{"protocolSection":{"identificationModule":{"nctId":"NCT05548647","orgStudyIdInfo":{"id":"850370"},"organization":{"fullName":"University of Pennsylvania","class":"OTHER"},"briefTitle":"Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects","officialTitle":"Short- and Long-term Effects of Once Weekly Semaglutide 2.4 mg on Appetite, Eating Behavior, and Psychosocial Status","acronym":"STABLE Wt Loss"},"statusModule":{"statusVerifiedDate":"2026-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-07-26","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-05-12","type":"ACTUAL"},"completionDateStruct":{"date":"2025-05-12","type":"ACTUAL"},"studyFirstSubmitDate":"2022-09-14","studyFirstSubmitQcDate":"2022-09-19","studyFirstPostDateStruct":{"date":"2022-09-21","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-03-30","resultsFirstSubmitQcDate":"2026-07-30","resultsFirstPostDateStruct":{"date":"2026-08-03","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-07-30","lastUpdatePostDateStruct":{"date":"2026-08-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Pennsylvania","class":"OTHER"},"collaborators":[{"name":"Novo Nordisk A/S","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"This study will evaluate the effect of semaglutide on eating behavior, appetite (hunger/fullness), and food liking in the long-term, as compared to placebo. All participants will receive lifestyle modification (diet and exercise) counseling, and will be prescribed the FDA-approved weight loss medication, semaglutide, or placebo (an inactive saline solution) for 72 weeks.","detailedDescription":"This trial consists of a single 72-week treatment period during which two studies will be conducted. Study 1 (i.e., long-term treatment trial; weeks 0-60) is a 60-week, single center, double-blinded, randomized controlled, parallel group design trial, and Study 2 (i.e., re-randomized medication withdrawal trial; weeks 60-72) is a separate, 12-week, double-blind, re-randomized medication withdrawal trial.\n\nThe long-term treatment trial (Study 1) will randomly assign (in a 3:2 semaglutide:placebo ratio) 120 subjects with a body mass index (BMI) ≥30 kg/m2, or ≥27 kg/m2 with ≥1 obesity-related co-morbidities, to 60 weeks of: 1) placebo with moderate intensity lifestyle intervention (as used in STEP 1); or 2) semaglutide 2.4 mg with the same lifestyle intervention. All subjects will receive 60 weeks of trial product, which will be up-titrated over 16 weeks in those assigned to semaglutide 2.4 mg. They will complete assessments of energy intake, appetite, food reward, mood, symptoms of disordered eating, and anthropomorphic measurements at baseline (week 0) and weeks 20, 40, and 60.\n\nThe primary aim in the initial long-term treatment trial will be to compare the long-term effect of semaglutide 2.4 mg vs placebo on ad libitum energy intake during a lunch meal at weeks 20, 40, and 60. Confirmatory secondary aims will test the effect of semaglutide 2.4 mg at weeks 20, 40 and 60 on subjective appetite ratings (both measured during a standardized breakfast in the lab and as experienced more globally over the past week), explicit food reward, as measured with the Power of Food Scale (24), and implicit food reward, as measured with the Leeds Food Preference Task (25, 26). Measures of food cravings, mood, eating disorder symptoms, and self-report measures of eating behavior will be considered supportive secondary endpoints and will provide additional evidence of the medication's safety and efficacy.\n\nFollowing the completion of Study 1 at week 60, all subjects who complete a week 60 assessment and remain on drug will be enrolled in Study 2. Semaglutide-treated subjects will be re-randomized (in a 1:4 semaglutide:placebo ratio) to receive semaglutide 2.4 mg or placebo for 12 weeks. All subjects originally assigned to placebo will continue with that medication for an additional 12 weeks. Both researchers and subjects will remain blinded to subjects' original and re-randomized (or continued) treatment assignments. The goal of this re-randomized medication withdrawal period will be to compare the 80% of subjects originally assigned to semaglutide 2.4 mg who receive placebo at week 60 (semaglutide-to-placebo group) to the subjects originally randomized to placebo (continuous-placebo group) on all primary and secondary outcome measures at week 72 (after controlling for Study 1 baseline/week 0 values). All subjects will terminate trial product at cumulative week 72 and will return to clinic for a final safety visit at week 76.\n\nOutcome assessments including ad libitum energy intake, subjective measures of appetite, food reward, eating behavior, mood, and eating disorder symptoms will occur at weeks 0, 20, 40, and 60 of Study 1 and at week 12 (72 weeks from original randomization) of the re-randomized treatment period. Measurements of body weight, waist circumference, blood pressure, pulse, and global, past-week appetite and food cravings (COEQ) also will be collected every 4 weeks throughout both treatment studies."},"conditionsModule":{"conditions":["Obesity"],"keywords":["Semaglutide","Body weight","Obesity","weight loss","medication","overweight","lifestyle modification","diet","exercise","Body Weight Changes","Appetitive Behavior"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Study 1 is a double-blind, placebo-controlled, randomized controlled, long-term treatment trial. Study 2 is a double-blind, medication withdrawal trial, re-randomized treatment trial.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Double-blind","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":120,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Behavioral Treatment + Placebo (weeks 0-60) // Continuous Placebo (weeks 60-72)","type":"ACTIVE_COMPARATOR","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group).","interventionNames":["Behavioral: Behavioral Treatment","Drug: Placebo"]},{"label":"Behavioral Treatment + Medication (weeks 0-60) // Switched to Placebo (weeks 60-72)","type":"ACTIVE_COMPARATOR","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). By re-allocating a small number of subjects to semaglutide-to-semaglutide at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the semaglutide-to-semaglutide group was not intended to be subject to statistical analysis. Therefore the week 72 results for this group represent those of the semaglutide-to-placebo group who took semaglutide for 60 weeks and then placebo for the last 12 weeks.","interventionNames":["Behavioral: Behavioral Treatment","Drug: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]"]}],"interventions":[{"type":"BEHAVIORAL","name":"Behavioral Treatment","description":"All participants, regardless of medication assignment, will receive the same 60-week behavioral weight loss program. Brief (15-minute), individual lifestyle counseling sessions will be delivered by a psychologist, behavioral health counselor, or registered dietitian (or other trained health care provider) at weeks 0 (i.e., baseline/randomization), 2, 4 and every fourth week from week 4 to week 60 (17 sessions) of Study 1. Subjects will be instructed to consume a self-selected diet of 1200-1500 kcal/day (for those who weigh \\< 250 lb) or 1500-1800 kcal/day (for those who weigh ≥250 lb). They will be instructed to engage in low-to-moderate intensity physical activity (e.g., walking), gradually building to a goal of ≥150 minutes per week (spread across 5 days) by week 40. They will be instructed to use calorie counting and self-monitoring to meet their goals.","armGroupLabels":["Behavioral Treatment + Medication (weeks 0-60) // Switched to Placebo (weeks 60-72)","Behavioral Treatment + Placebo (weeks 0-60) // Continuous Placebo (weeks 60-72)"],"otherNames":["Lifestyle modification","Behavioral weight loss","Lifestyle intervention"]},{"type":"DRUG","name":"Placebo","description":"An inactive saline solution administered via subcutaneous injection","armGroupLabels":["Behavioral Treatment + Placebo (weeks 0-60) // Continuous Placebo (weeks 60-72)"],"otherNames":["Placebo for medication"]},{"type":"DRUG","name":"Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]","description":"Semaglutide 2.4 mg is a once weekly subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonist that has been FDA approved for weight loss","armGroupLabels":["Behavioral Treatment + Medication (weeks 0-60) // Switched to Placebo (weeks 60-72)"],"otherNames":["Wegovy"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Study 1 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)","description":"Primary outcome (Study 1)","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 2 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)","description":"Primary outcome (Study 2)","timeFrame":"S2: Endpoint comparison at week 72"}],"secondaryOutcomes":[{"measure":"Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting","description":"Secondary confirmatory outcome (Study 1): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured when fasting prior to eating a standardized breakfast. Score range 0-100 mm. Higher values indicate greater suppression (i.e., less appetite).","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) After Eating (Area Under the Curve)","description":"Secondary confirmatory outcome (Study 1): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured every 30 minutes in the 4 hours after eating a standardized breakfast. Post-prandial scores were combined into a single area under the curve value using the trapezoidal method. Possible area range: 0 - 24,000. Higher values indicate greater suppression (i.e., less appetite).","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 1): Visual analogue scale rating of hunger during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater hunger.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 1): Visual analogue scale rating of fullness after meals during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater fullness after meals.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 1): Visual analogue scale rating of food preoccupation during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater food preoccupation.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)","description":"Secondary confirmatory outcome (Study 1): Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version). Score range 1-5. Higher scores indicate greater responsiveness to the food environment.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task","description":"Secondary confirmatory outcome (Study 1): Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task. Scores range from -100 to +100 with higher scores indicating a greater implicit wanting of high-fat savory foods.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting","description":"Secondary confirmatory outcome (Study 2): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured when fasting prior to eating a standardized breakfast. Score range 0-100 mm. Higher values indicate greater suppression (i.e., less appetite).","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline"},{"measure":"Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) After Eating (Area Under the Curve)","description":"Secondary confirmatory outcome (Study 2): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured every 30 minutes in the 4 hours after eating a standardized breakfast. Post-prandial scores were combined into a single area under the curve value using the trapezoidal method. Possible area range: 0 - 24,000. Higher values indicate greater suppression (i.e., less appetite).","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline"},{"measure":"Study 2 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 2): Visual analogue scale rating of hunger during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater hunger.","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline"},{"measure":"Study 2 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 2): Visual analogue scale rating of fullness after meals during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater fullness after meals.","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline"},{"measure":"Study 2 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 2): Visual analogue scale rating of food preoccupation during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater food preoccupation.","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline"},{"measure":"Study 2 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)","description":"Secondary confirmatory outcome (Study 2): Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version). Score range 1-5. Higher scores indicate greater responsiveness to the food environment.","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline"},{"measure":"Study 2 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task","description":"Secondary confirmatory outcome (Study 2): Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task. Scores range from -100 to +100 with higher scores indicating a greater implicit wanting of high-fat savory foods.","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline"}],"otherOutcomes":[{"measure":"Study 1 Body Weight (kg)","description":"Supportive secondary outcome (Study 1): Body weight change (kg)","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Craving Control Over the Past Week as Measured by the COEQ","description":"Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving control (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater ability to control food cravings.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Craving for Savory Over the Past Week as Measured by the COEQ","description":"Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for savory foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for savory foods.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Craving for Sweet Over the Past Week as Measured by the COEQ","description":"Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for sweet foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for sweet foods.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Food Cravings as Measured by the General Food Cravings Questionnaire - Trait","description":"Supportive secondary outcome (Study 1): Food cravings as measured by the General Food Cravings Questionnaire - Trait (G-FCQ-T 21-item). Score range 21-126, higher scores indicate more/stronger food cravings.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Explicit Liking of High-fat Savory Foods (LFPT)","description":"Supportive secondary outcome (Study 1) Explicit liking of high-fat savory foods as measured on 100-mm VAS scales (mean of high-fat savory items) during the Leeds Food Preference Task. Score range 0 - 100 mm with higher scores indicating greater liking of high-fat savory foods.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Cognitive Restraint (Eating Inventory)","description":"Supportive secondary outcome (Study 1): Eating behavior - cognitive restraint subscale of the Eating Inventory (EI). Score range 0-21, higher=more dietary restraint.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Disinhibition (Eating Inventory)","description":"Supportive secondary outcome (Study 1): Eating behavior - disinhibition subscale of the Eating Inventory. Score range 0-16, higher=more disinhibition.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Weight-related Self-efficacy","description":"Supportive secondary outcome (Study 1) Mean score on the Weight-related self-efficacy (WEL-short form). Sum of 8 items, score range 0-80, higher scores indicate greater weight-related self-efficacy.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Mood as Assessed Using the PHQ-9","description":"Supportive secondary outcome (Study 1): Depressed mood as assessed using the PHQ-9. Score range 0 - 27; higher scores indicate more symptoms of depressed mood.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Clinician-rated Binge Eating Frequency (Sum of Objective and Subjective Binge Eating Frequency)","description":"Supportive secondary outcome (Study 1): Clinician-rated binge eating frequency (sum of objective and subjective binge eating frequency) in the past 12 weeks as assessed by the Eating Disorder Examination (EDE). Score is the count of binge episodes, range ≥0, more episodes indicates more frequent binge eating in the past 12 weeks.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Self-reported Loss-of-control Eating (Loss of Control Eating Scale)","description":"Supportive secondary outcome (Study 1): Self-reported loss-of-control eating as measured by the Loss of Control Eating Scale (LOCES). Mean score range 1-5; higher scores indicate greater/more frequent loss of control over eating.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Food Addiction Symptoms Measured by Yale Food Addiction Scale","description":"Exploratory outcome (Study 1): Food addiction symptoms measured by Yale Food Addiction Scale (YFAS). Symptom number range 0-11, higher scores indicate more food addiction symptoms","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Drive for Thinness (Eating Disorder Inventory [EDI])","description":"Supportive secondary outcome (Study 1): Study 1 Drive for thinness as measured by the Eating Disorder Inventory (EDI). Score range 0-28; higher scores indicate greater drive for thinness.","timeFrame":"Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Ratings of Nausea When Fasting","description":"Exploratory outcome (Study 1): Ratings of nausea using 100 mm visual analogue scales when fasting in the laboratory prior to consuming the standard breakfast meal. Score range 0-100 mm; higher scores indicate greater nausea.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Ratings of Food Palatability","description":"Exploratory outcome (Study 1): Ratings of food palatability using 100 mm visual analogue scales during a laboratory test meal. Score range 0-100 mm; higher scores indicate higher liking of the food taste.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Body Image Dissatisfaction (Body Satisfaction Scale)","description":"Exploratory outcome (Study 1): Body image dissatisfaction (Body Satisfaction Scale). Mean of 13 items, score range 1-7, higher scores indicate greater body part dissatisfaction.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 1 Weight-related Self Stigmatization","description":"Exploratory outcome (Study 1): Weight-related self stigmatization by the Weight Bias Internalization Scale. Mean of 11 items; score range 1-7; higher scores indicate greater weight-related self-stigmatization.","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60"},{"measure":"Study 2 Body Weight (kg)","description":"Supportive secondary outcome (Study 2): Body weight (kg) at week 72","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Men and women who report a desire to lose weight\n2. Aged 18-70 years\n3. Body mass index \\[BMI\\] ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 with an obesity-related comorbidity (e.g., treated or untreated hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)\n4. Eligible female patients will be:\n\n   * non-pregnant, evidenced by a negative urine pregnancy test\n   * non-lactating\n   * surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study\n5. Subjects must\n\n   * Plan to remain in the Philadelphia area for the next 1.5 years.\n   * Ability to provide informed consent before any trial-related activities.\n\nExclusion Criteria:\n\n1. A diagnosis of type I or II diabetes\n2. Hemoglobin A1c (HbA1c) \\> 6.5%\n3. Uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg)\n4. Clinically significant hepatic (i.e., liver fibrosis, cirrhosis or confirmed NASH) or renal disease\n5. Uncontrolled thyroid disease\n6. Experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 6 months, congestive heart failure, or heart block greater than first degree\n7. A history of acute pancreatitis in the last 6 months\n8. Any history of chronic pancreatitis\n9. A history of malignancy (other than non-melanoma skin cancer) within the last 5 years\n10. A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2\n11. A self-reported change in body weight \\>5kg (11 lbs) within 90 days before screening\n12. Used within the last 6 months medications known to produce weight loss/gain (e.g., medications approved for weight loss, oral steroids, antipsychotic medications) or any GLP-1 receptor agonist.\n13. Known or suspected allergy or hypersensitivity to trial medication(s), excipients, or related products\n14. The receipt of any investigational drug within 6 months prior to this trial\n15. Applicants with current severe major depressive disorder (BDI-II score ≥ 29 or Patient Health Questionnaire-9 \\[PHQ-9\\] score \\> 15) or severe anxiety disorder\n16. Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year (such individuals will be referred for psychiatric treatment if they have not previously received it).\n17. Any severity of psychotic or bipolar disorder\n18. Bulimia nervosa diagnosis within the past 5 years\n19. Self-reported alcohol or substance abuse within the past 6 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)\n20. History of (or plans to receive in the next 1.5 years) bariatric surgery or a weight loss device. (However, the following will be allowed: liposuction or abdominoplasty \\> 1 year before screening, laparoscopic banding if removed \\> 1 year before screening, intragastric balloon or aspire assist if removed \\> 1 year before screening.)\n21. Inability to walk 5 blocks or more (comfortably) or engage in another form of aerobic activity.\n22. Women who are nursing, pregnant, or planning to become pregnant in the next 1.5 years or are not using adequate contraceptive measures\n23. Previous participation in this trial (e.g., randomized but failed to participate)\n24. Changes to any chronic medication (type or dosage) within the past 3 months.\n25. Food allergy or dietary preference that would prevent the individual from consuming the standard breakfast or ad libitum lunch.\n\n1\\. To be eligible to participate in the re-randomized treatment period from weeks 60 to 72, subjects must also:\n\n* complete a week 60 assessment\n* be classified as \"on drug\" as at the week 60 assessment and report taking at least one dose of trial product within the past 2 weeks","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"University of Pennsylvania Center for Weight and Eating Disorders","city":"Philadelphia","state":"Pennsylvania","zip":"19104","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}}]},"referencesModule":{"references":[{"pmid":"42323166","type":"DERIVED","citation":"Tronieri JS, Allison KC, DeRouen K, Amaro A, Collins KG, Roy A, Watts S, Ananna T, Wadden TA. Short- and long-term effects of semaglutide 2.4 mg on energy intake, appetite, and food reward: a 60-week, double-blind randomized controlled trial. Am J Clin Nutr. 2026 Aug;124(2):101403. doi: 10.1016/j.ajcnut.2026.101403. Epub 2026 Jun 20."},{"pmid":"38655793","type":"DERIVED","citation":"Gordon K, Matthews A, Zeller MH, Lin J. Practical guidelines for eating disorder risk mitigation in patients undergoing obesity treatment for the pediatric provider. Curr Opin Pediatr. 2024 Aug 1;36(4):367-374. doi: 10.1097/MOP.0000000000001356. Epub 2024 Apr 5."}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"We sought to capitalize on the long-term design of Study 1 by conducting a separate, 12-week, medication withdrawal trial (Study 2) to compare subjects who discontinued semaglutide 2.4 mg to those who had never received active medication (continuous placebo). A very small number of subjects were randomized to continue taking semaglutide at week 60 to maintain blinding. Number of continued subjects was not sufficient for statistical comparison and their Study 2 results are not reported.","recruitmentDetails":"Participants were recruited between July 2022 and February 2024 via print and social media advertisements.","groups":[{"id":"FG000","title":"Behavioral Treatment + Placebo (Weeks 0-60) // Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60. At week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"FG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nOnly Study 1 completers who were on drug were eligible for participation in Study 2, and reassignment of the semaglutide group did not occur until week 60. Therefore it is not possible to separate Medication - switched to placebo and Continued medication prior to that timepoint."},{"id":"FG002","title":"Behavioral Treatment + Medication (Weeks 0-60) // Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60. At week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). By re-allocating a small number of subjects to semaglutide-to-semaglutide at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. Participant flow for this group is being used to show the number of participants, out of those who were originally assigned to Behavioral Treatment + Medication, who were enrolled in Study 2 and re-randomized to take placebo from weeks 60 - 72.\n\nOnly Study 1 completers who were on drug were eligible for participation in Study 2, and reassignment of the semaglutide group did not occur until week 60. Therefore it is not possible to separate the Medication - Switched to Placebo and Continued Medication groups prior to that timepoint."},{"id":"FG003","title":"Behavioral Treatment + Medication (Weeks 0-60) // Continuous Medication (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60. At week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). By re-allocating a small number of subjects to semaglutide-to-semaglutide at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. Participant flow for this group is being used to show the number of participants, out of those who were originally assigned to Behavioral Treatment + Medication, who were enrolled in Study 2 and re-randomized to continue to take semaglutide (Continuous Medication) from weeks 60 - 72.\n\nOnly Study 1 completers who were on drug were eligible for participation in Study 2, and reassignment of the semaglutide group did not occur until week 60. Therefore it is not possible to separate the Medication - Switched to Placebo and Continued Medication prior to that timepoint.\n\nRe-allocation of a small number of participants to Continuous Medication was used to maintain blinding of researchers and participants to treatment condition. (Re-randomization was conducted by staff not involved in the trial and thus both also remained blinded to original treatment assignment.) This group was not intended to be analyzed or subject to statistical comparisons."}],"periods":[{"title":"Study 1: Weeks 0-60","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"72"},{"groupId":"FG002","comment":"Participants in the original Behavioral Treatment + Medication group were not yet enrolled in Study 2 and re-randomized to be Switched to Placebo or to Continuous Medication until after completion of Study 1. Therefore completion values do not exist for the re-randomized groups during Study 1.","numSubjects":"0"},{"groupId":"FG003","comment":"Participants in the original Behavioral Treatment + Medication group were not yet enrolled in Study 2 and re-randomized to be Switched to Placebo or to Continuous Medication until after completion of Study 1. Therefore completion values do not exist for the re-randomized groups during Study 1.","numSubjects":"0"}]},{"type":"Week 20","achievements":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"70"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Week 40","achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"62"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"61"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Study 2: Weeks 60-72","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","comment":"After completion of the week 60 assessment (end of Study 1), the subset of eligible participants in the original Behavioral Treatment + Medication group were re-randomized to be Switched to Placebo or to Continuous Medication during a separate 12-week withdrawal study. The total number of participants assigned to Behavioral Treatment + Medication who then enrolled in Study 2 was 53. Their Study 2 progress is shown based on their Study 2 assignment.","numSubjects":"0"},{"groupId":"FG002","numSubjects":"43"},{"groupId":"FG003","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"41"},{"groupId":"FG003","numSubjects":"9"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, eligible placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group) in Study 2."},{"id":"BG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, eligible medication-treated participants were re-randomized to be switched to placebo or continue active medication for an additional 12 weeks (i.e., continuous placebo group) in Study 2. Only Study 1 completers who were on drug at week 60 were eligible for participation in Study 2, and reassignment of the semaglutide group did not occur until week 60. Therefore it is not possible to separate the Medication - Switched to Placebo and Continued Medication groups prior to that timepoint, including at baseline of Phase 1."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"120"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.2","spread":"12.7"},{"groupId":"BG001","value":"46.7","spread":"11.5"},{"groupId":"BG002","value":"45.7","spread":"12.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"94"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"26"}]}]}]},{"title":"Race/Ethnicity, Customized","description":"Race (self-identified)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"86"}]}]},{"title":"Black","categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"26"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}]},{"title":"Other or more than one","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Race/Ethnicity, Customized","description":"Ethnicity (self-identified)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"11"}]}]},{"title":"Middle Eastern/Arab","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}]},{"title":"Both Hispanic and Middle Eastern/Arab","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]},{"title":"Not Hispanic or Middle Eastern/Arab","categories":[{"measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"63"},{"groupId":"BG002","value":"105"}]}]}]},{"title":"Body weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"106.2","spread":"19.4"},{"groupId":"BG001","value":"106.9","spread":"21.4"},{"groupId":"BG002","value":"106.6","spread":"20.6"}]}]}]},{"title":"Lunch intake","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kcal","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1053.0","spread":"329.4"},{"groupId":"BG001","value":"1050.6","spread":"358.9"},{"groupId":"BG002","value":"1051.5","spread":"345.9"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Study 1 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)","description":"Primary outcome (Study 1)","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"kcal","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-75.1","spread":"52.6"},{"groupId":"OG001","value":"-367.0","spread":"37.2"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-76.8","spread":"73.8"},{"groupId":"OG001","value":"-317.0","spread":"49.7"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"69.6","spread":"73.9"},{"groupId":"OG001","value":"-200.0","spread":"50.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"291.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"164.0","ciUpperLimit":"419.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"64.4"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0078","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"240.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"65.2","ciUpperLimit":"415.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"87.8"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0019","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"269.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"102.8","ciUpperLimit":"436.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"83.6"}]},{"type":"SECONDARY","title":"Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting","description":"Secondary confirmatory outcome (Study 1): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured when fasting prior to eating a standardized breakfast. Score range 0-100 mm. Higher values indicate greater suppression (i.e., less appetite).","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"3.8","spread":"2.6"},{"groupId":"OG001","value":"16.0","spread":"2.0"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"3.6"},{"groupId":"OG001","value":"6.9","spread":"2.4"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"3.6"},{"groupId":"OG001","value":"2.3","spread":"2.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0004","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-12.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-18.6","ciUpperLimit":"-5.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.3"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0784","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-7.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.6","ciUpperLimit":"0.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.1"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.9","ciUpperLimit":"7.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.0"}]},{"type":"SECONDARY","title":"Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) After Eating (Area Under the Curve)","description":"Secondary confirmatory outcome (Study 1): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured every 30 minutes in the 4 hours after eating a standardized breakfast. Post-prandial scores were combined into a single area under the curve value using the trapezoidal method. Possible area range: 0 - 24,000. Higher values indicate greater suppression (i.e., less appetite).","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm*min","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"1112.3","spread":"665.2"},{"groupId":"OG001","value":"3309.3","spread":"470.4"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"645.5","spread":"1125.5"},{"groupId":"OG001","value":"2595.1","spread":"608.8"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"712.5","spread":"1050.4"},{"groupId":"OG001","value":"2065.8","spread":"650.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0090","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-2197.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3832.2","ciUpperLimit":"822.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"822.9"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.1383","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1949.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4550.1","ciUpperLimit":"650.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1293.5"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1353.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3799.2","ciUpperLimit":"1092.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1219.6"}]},{"type":"SECONDARY","title":"Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 1): Visual analogue scale rating of hunger during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater hunger.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-14.4","spread":"4.0"},{"groupId":"OG001","value":"-31.9","spread":"2.7"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-14.6","spread":"5.0"},{"groupId":"OG001","value":"-25.4","spread":"3.2"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-10.6","spread":"4.4"},{"groupId":"OG001","value":"-17.4","spread":"3.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0004","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"17.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"7.9","ciUpperLimit":"27.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.8"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.061","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"10.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.5","ciUpperLimit":"22.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"6.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.5","ciUpperLimit":"17.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.2"}]},{"type":"SECONDARY","title":"Study 1 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 1): Visual analogue scale rating of fullness after meals during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater fullness after meals.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"8.9","spread":"3.7"},{"groupId":"OG001","value":"10.8","spread":"2.5"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"8.2","spread":"4.4"},{"groupId":"OG001","value":"4.9","spread":"2.9"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"5.9","spread":"4.1"},{"groupId":"OG001","value":"4.3","spread":"2.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.671","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.0","ciUpperLimit":"7.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.5"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"3.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.1","ciUpperLimit":"13.7","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.2"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"1.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.9","ciUpperLimit":"11.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.8"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Body Weight (kg)","description":"Supportive secondary outcome (Study 1): Body weight change (kg)","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-5.2","spread":"0.9"},{"groupId":"OG001","value":"-9.9","spread":"0.6"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-6.0","spread":"1.4"},{"groupId":"OG001","value":"-15.0","spread":"1.0"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-3.6","spread":"1.9"},{"groupId":"OG001","value":"-15.4","spread":"1.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"4.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.5","ciUpperLimit":"6.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.1"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"9.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.7","ciUpperLimit":"12.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"11.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"7.3","ciUpperLimit":"16.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.2"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Craving Control Over the Past Week as Measured by the COEQ","description":"Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving control (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater ability to control food cravings.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"19.3","spread":"3.8"},{"groupId":"OG001","value":"32.2","spread":"2.8"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"15.8","spread":"4.1"},{"groupId":"OG001","value":"30.2","spread":"2.7"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"14.7","spread":"4.6"},{"groupId":"OG001","value":"27.1","spread":"3.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.007","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-12.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-22.2","ciUpperLimit":"-3.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.005","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-14.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-24.3","ciUpperLimit":"-4.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.9"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.020","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-12.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-22.8","ciUpperLimit":"-2.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.2"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Craving for Savory Over the Past Week as Measured by the COEQ","description":"Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for savory foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for savory foods.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-18.5","spread":"3.7"},{"groupId":"OG001","value":"-29.9","spread":"2.6"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-16.6","spread":"4.0"},{"groupId":"OG001","value":"-27.1","spread":"2.6"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-14.9","spread":"4.4"},{"groupId":"OG001","value":"-19.8","spread":"2.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":".016","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"11.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.2","ciUpperLimit":"20.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.6"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.031","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"10.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.0","ciUpperLimit":"20.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.8"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.320","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"4.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.9","ciUpperLimit":"14.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.9"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Craving for Sweet Over the Past Week as Measured by the COEQ","description":"Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for sweet foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for sweet foods.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-17.5","spread":"3.9"},{"groupId":"OG001","value":"-23.0","spread":"2.8"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-17.5","spread":"3.9"},{"groupId":"OG001","value":"-15.8","spread":"2.9"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-15.0","spread":"4.2"},{"groupId":"OG001","value":"-11.7","spread":"3.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.256","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"5.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.0","ciUpperLimit":"14.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.8"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.726","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.5","ciUpperLimit":"8.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.9"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.496","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-3.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-13.0","ciUpperLimit":"6.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.9"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Food Cravings as Measured by the General Food Cravings Questionnaire - Trait","description":"Supportive secondary outcome (Study 1): Food cravings as measured by the General Food Cravings Questionnaire - Trait (G-FCQ-T 21-item). Score range 21-126, higher scores indicate more/stronger food cravings.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-11.0","spread":"2.6"},{"groupId":"OG001","value":"-18.4","spread":"1.8"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-8.8","spread":"2.9"},{"groupId":"OG001","value":"-20.2","spread":"1.9"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-9.7","spread":"3.6"},{"groupId":"OG001","value":"-18.6","spread":"2.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.022","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"7.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.1","ciUpperLimit":"13.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.2"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"11.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.7","ciUpperLimit":"18.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.4"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.035","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"8.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.7","ciUpperLimit":"17.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.1"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Explicit Liking of High-fat Savory Foods (LFPT)","description":"Supportive secondary outcome (Study 1) Explicit liking of high-fat savory foods as measured on 100-mm VAS scales (mean of high-fat savory items) during the Leeds Food Preference Task. Score range 0 - 100 mm with higher scores indicating greater liking of high-fat savory foods.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-5.1","spread":"4.0"},{"groupId":"OG001","value":"-15.4","spread":"2.5"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"5.5"},{"groupId":"OG001","value":"-10.3","spread":"3.3"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-7.0","spread":"4.8"},{"groupId":"OG001","value":"-9.8","spread":"3.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.032","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"10.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.9","ciUpperLimit":"19.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.171","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"8.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.6","ciUpperLimit":"19.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.8"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.584","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"2.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.3","ciUpperLimit":"12.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.0"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Cognitive Restraint (Eating Inventory)","description":"Supportive secondary outcome (Study 1): Eating behavior - cognitive restraint subscale of the Eating Inventory (EI). Score range 0-21, higher=more dietary restraint.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"3.8","spread":"0.6"},{"groupId":"OG001","value":"4.5","spread":"0.4"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"3.5","spread":"0.7"},{"groupId":"OG001","value":"4.0","spread":"0.5"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"2.3","spread":"0.5"},{"groupId":"OG001","value":"3.2","spread":"0.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.334","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-0.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.2","ciUpperLimit":"0.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.593","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-0.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.2","ciUpperLimit":"1.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.9"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.159","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.3","ciUpperLimit":"0.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.7"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Disinhibition (Eating Inventory)","description":"Supportive secondary outcome (Study 1): Eating behavior - disinhibition subscale of the Eating Inventory. Score range 0-16, higher=more disinhibition.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"0.5"},{"groupId":"OG001","value":"-3.3","spread":"0.3"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"0.6"},{"groupId":"OG001","value":"-3.8","spread":"0.4"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"0.6"},{"groupId":"OG001","value":"-3.5","spread":"0.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.003","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"1.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.7","ciUpperLimit":"3.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.6"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"2.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.1","ciUpperLimit":"3.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.008","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"1.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.5","ciUpperLimit":"3.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.7"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Weight-related Self-efficacy","description":"Supportive secondary outcome (Study 1) Mean score on the Weight-related self-efficacy (WEL-short form). Sum of 8 items, score range 0-80, higher scores indicate greater weight-related self-efficacy.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"10.3","spread":"2.6"},{"groupId":"OG001","value":"14.5","spread":"1.9"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"8.6","spread":"3.5"},{"groupId":"OG001","value":"16.6","spread":"2.3"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"3.9","spread":"3.9"},{"groupId":"OG001","value":"14.5","spread":"2.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.204","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-4.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-10.7","ciUpperLimit":"2.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.3"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.051","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-7.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.8","ciUpperLimit":"0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.0"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.023","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-10.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-19.7","ciUpperLimit":"-1.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.6"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Mood as Assessed Using the PHQ-9","description":"Supportive secondary outcome (Study 1): Depressed mood as assessed using the PHQ-9. Score range 0 - 27; higher scores indicate more symptoms of depressed mood.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"0.6"},{"groupId":"OG001","value":"-1.0","spread":"0.4"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"0.6"},{"groupId":"OG001","value":"-1.6","spread":"0.4"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"0.8"},{"groupId":"OG001","value":"-2.0","spread":"0.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.822","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.5","ciUpperLimit":"1.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.626","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.8","ciUpperLimit":"1.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.549","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.3","ciUpperLimit":"2.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.9"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Clinician-rated Binge Eating Frequency (Sum of Objective and Subjective Binge Eating Frequency)","description":"Supportive secondary outcome (Study 1): Clinician-rated binge eating frequency (sum of objective and subjective binge eating frequency) in the past 12 weeks as assessed by the Eating Disorder Examination (EDE). Score is the count of binge episodes, range ≥0, more episodes indicates more frequent binge eating in the past 12 weeks.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Binge episodes","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-4.2","spread":"2.3"},{"groupId":"OG001","value":"-4.9","spread":"1.3"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-3.9","spread":"2.3"},{"groupId":"OG001","value":"-5.0","spread":"1.3"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-3.7","spread":"2.4"},{"groupId":"OG001","value":"-4.9","spread":"1.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.583","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.6","ciUpperLimit":"6.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.274","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"1.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.2","ciUpperLimit":"6.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.324","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"1.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.1","ciUpperLimit":"6.7","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.7"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Self-reported Loss-of-control Eating (Loss of Control Eating Scale)","description":"Supportive secondary outcome (Study 1): Self-reported loss-of-control eating as measured by the Loss of Control Eating Scale (LOCES). Mean score range 1-5; higher scores indicate greater/more frequent loss of control over eating.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.1"},{"groupId":"OG001","value":"-0.8","spread":"0.1"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.1"},{"groupId":"OG001","value":"-0.9","spread":"0.1"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.1"},{"groupId":"OG001","value":"-0.8","spread":"0.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.005","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.1","ciUpperLimit":"0.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.1"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.2","ciUpperLimit":"0.7","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.1"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.076","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.03","ciUpperLimit":"0.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.1"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Food Addiction Symptoms Measured by Yale Food Addiction Scale","description":"Exploratory outcome (Study 1): Food addiction symptoms measured by Yale Food Addiction Scale (YFAS). Symptom number range 0-11, higher scores indicate more food addiction symptoms","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Number of symptoms","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"0.4"},{"groupId":"OG001","value":"-1.6","spread":"0.3"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"0.4"},{"groupId":"OG001","value":"-1.9","spread":"0.2"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"0.4"},{"groupId":"OG001","value":"-2.1","spread":"0.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.425","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.5","ciUpperLimit":"1.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.5"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.776","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.8","ciUpperLimit":"1.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.5"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.492","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.7","ciUpperLimit":"1.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.5"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Drive for Thinness (Eating Disorder Inventory [EDI])","description":"Supportive secondary outcome (Study 1): Study 1 Drive for thinness as measured by the Eating Disorder Inventory (EDI). Score range 0-28; higher scores indicate greater drive for thinness.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"0.8"},{"groupId":"OG001","value":"-1.9","spread":"0.6"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"0.9"},{"groupId":"OG001","value":"-2.6","spread":"0.7"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"0.9"},{"groupId":"OG001","value":"-3.8","spread":"0.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.046","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"2.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.04","ciUpperLimit":"4.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.1"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.009","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"3.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.8","ciUpperLimit":"5.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.2"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.022","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"2.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.4","ciUpperLimit":"4.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.1"}]},{"type":"PRIMARY","title":"Study 2 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)","description":"Primary outcome (Study 2)","populationDescription":"Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation.\n\nThe goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"kcal","timeFrame":"S2: Endpoint comparison at week 72","groups":[{"id":"OG000","title":"Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"OG001","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60.\n\nThe primary goal of the 12-week withdrawal trial (Study 2) was to compare individuals who had discontinued semaglutide at week 60 (by being randomly assigned to switch to placebo at that time) to those who had never taken active medication (Continuous Placebo group), in order to evaluate whether those who discontinued medication were significantly worse off, in terms of appetite, than those who had never been exposed to the medication at week 72.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis."},{"id":"OG002","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1073.0","spread":"71.1"},{"groupId":"OG001","value":"951.8","spread":"42.9"},{"groupId":"OG002","value":"657.7","spread":"81.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared the week 72 endpoint controlling for baseline values (week 0 of study 1) between the Switched to Placebo and Continuous Placebo groups.\n\nThe Continued Medication group was used for blinding and not intended for statistical comparison. Continued Medication participants may appear different by chance due to small sample size.","nonInferiorityType":"SUPERIORITY","pValue":"0.1513","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"121.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-46.0","ciUpperLimit":"288.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"83.1"}]},{"type":"SECONDARY","title":"Study 1 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 1): Visual analogue scale rating of food preoccupation during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater food preoccupation.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-14.7","spread":"3.7"},{"groupId":"OG001","value":"-29.6","spread":"2.6"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-17.0","spread":"4.1"},{"groupId":"OG001","value":"-24.9","spread":"2.7"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-13.1","spread":"3.6"},{"groupId":"OG001","value":"-22.4","spread":"2.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0014","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"14.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.0","ciUpperLimit":"23.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.5"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.111","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"7.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.8","ciUpperLimit":"17.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.9"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Median Difference (Net)","paramValue":"9.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.9","ciUpperLimit":"17.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.3"}]},{"type":"SECONDARY","title":"Study 1 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)","description":"Secondary confirmatory outcome (Study 1): Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version). Score range 1-5. Higher scores indicate greater responsiveness to the food environment.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-0.55","spread":"0.13"},{"groupId":"OG001","value":"-0.98","spread":"0.09"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-0.51","spread":"0.15"},{"groupId":"OG001","value":"-1.10","spread":"0.09"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-0.67","spread":"0.18"},{"groupId":"OG001","value":"-1.01","spread":"0.12"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0059","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.13","ciUpperLimit":"0.74","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.15"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0009","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.25","ciUpperLimit":"0.94","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.17"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.0987","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.07","ciUpperLimit":"0.74","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.20"}]},{"type":"SECONDARY","title":"Study 1 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task","description":"Secondary confirmatory outcome (Study 1): Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task. Scores range from -100 to +100 with higher scores indicating a greater implicit wanting of high-fat savory foods.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-3.7","spread":"4.1"},{"groupId":"OG001","value":"-5.9","spread":"2.7"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"4.7","spread":"4.7"},{"groupId":"OG001","value":"-0.6","spread":"2.9"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"2.6","spread":"5.1"},{"groupId":"OG001","value":"-1.9","spread":"3.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.6401","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"2.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.4","ciUpperLimit":"11.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.9"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"5.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.9","ciUpperLimit":"15.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.1"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValueComment":"Sequential testing was used for these primary and secondary endpoints in order to control for type 1 error. Thus, p values are not displayed if the earlier time point did not reach statistical significance at an alpha of 0.05.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"4.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.3","ciUpperLimit":"15.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.4"}]},{"type":"SECONDARY","title":"Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting","description":"Secondary confirmatory outcome (Study 2): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured when fasting prior to eating a standardized breakfast. Score range 0-100 mm. Higher values indicate greater suppression (i.e., less appetite).","populationDescription":"Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation.\n\nThe goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline","groups":[{"id":"OG000","title":"Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"OG001","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60.\n\nThe primary goal of the 12-week withdrawal trial (Study 2) was to compare individuals who had discontinued semaglutide at week 60 (by being randomly assigned to switch to placebo at that time) to those who had never taken active medication (Continuous Placebo group), in order to evaluate whether those who discontinued medication were significantly worse off, in terms of appetite, than those who had never been exposed to the medication at week 72.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis."},{"id":"OG002","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.7","spread":"3.8"},{"groupId":"OG001","value":"32.7","spread":"2.3"},{"groupId":"OG002","value":"47.7","spread":"5.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared the week 72 endpoint controlling for baseline values (week 0 of study 1) between the Switched to Placebo and Continuous Placebo groups.\n\nThe Continued Medication group was used for blinding and not intended for statistical comparison. Continued Medication participants may appear different by chance due to small sample size.","nonInferiorityType":"SUPERIORITY","pValue":"0.8199","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"1.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.1","ciUpperLimit":"10.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.5"}]},{"type":"SECONDARY","title":"Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) After Eating (Area Under the Curve)","description":"Secondary confirmatory outcome (Study 2): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured every 30 minutes in the 4 hours after eating a standardized breakfast. Post-prandial scores were combined into a single area under the curve value using the trapezoidal method. Possible area range: 0 - 24,000. Higher values indicate greater suppression (i.e., less appetite).","populationDescription":"Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation.\n\nThe goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm*min","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline","groups":[{"id":"OG000","title":"Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"OG001","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60.\n\nThe primary goal of the 12-week withdrawal trial (Study 2) was to compare individuals who had discontinued semaglutide at week 60 (by being randomly assigned to switch to placebo at that time) to those who had never taken active medication (Continuous Placebo group), in order to evaluate whether those who discontinued medication were significantly worse off, in terms of appetite, than those who had never been exposed to the medication at week 72.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis."},{"id":"OG002","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14354","spread":"997"},{"groupId":"OG001","value":"14533","spread":"668"},{"groupId":"OG002","value":"16914","spread":"1292"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared the week 72 endpoint controlling for baseline values (week 0 of study 1) between the Switched to Placebo and Continuous Placebo groups.\n\nThe Continued Medication group was used for blinding and not intended for statistical comparison. Continued Medication participants may appear different by chance due to small sample size.","nonInferiorityType":"SUPERIORITY","pValue":"0.8832","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-179","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2608","ciUpperLimit":"2250","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1209"}]},{"type":"SECONDARY","title":"Study 2 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 2): Visual analogue scale rating of hunger during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater hunger.","populationDescription":"Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation.\n\nThe goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline","groups":[{"id":"OG000","title":"Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"OG001","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"BehavBehavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60.\n\nThe primary goal of the 12-week withdrawal trial (Study 2) was to compare individuals who had discontinued semaglutide at week 60 (by being randomly assigned to switch to placebo at that time) to those who had never taken active medication (Continuous Placebo group), in order to evaluate whether those who discontinued medication were significantly worse off, in terms of appetite, than those who had never been exposed to the medication at week 72.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis."},{"id":"OG002","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"48.5","spread":"5.2"},{"groupId":"OG001","value":"63.6","spread":"3.5"},{"groupId":"OG002","value":"38.5","spread":"7.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared the week 72 endpoint controlling for baseline values (week 0 of study 1) between the Switched to Placebo and Continuous Placebo groups.\n\nThe Continued Medication group was used for blinding and not intended for statistical comparison. Continued Medication participants may appear different by chance due to small sample size.","nonInferiorityType":"SUPERIORITY","pValue":"0.0196","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-15.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-27.6","ciUpperLimit":"-2.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"6.3"}]},{"type":"SECONDARY","title":"Study 2 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 2): Visual analogue scale rating of fullness after meals during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater fullness after meals.","populationDescription":"Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation.\n\nThe goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline","groups":[{"id":"OG000","title":"Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"OG001","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60.\n\nThe primary goal of the 12-week withdrawal trial (Study 2) was to compare individuals who had discontinued semaglutide at week 60 (by being randomly assigned to switch to placebo at that time) to those who had never taken active medication (Continuous Placebo group), in order to evaluate whether those who discontinued medication were significantly worse off, in terms of appetite, than those who had never been exposed to the medication at week 72.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis."},{"id":"OG002","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57.4","spread":"5.0"},{"groupId":"OG001","value":"59.4","spread":"3.5"},{"groupId":"OG002","value":"76.7","spread":"6.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared the week 72 endpoint controlling for baseline values (week 0 of study 1) between the Switched to Placebo and Continuous Placebo groups.\n\nThe Continued Medication group was used for blinding and not intended for statistical comparison. Continued Medication participants may appear different by chance due to small sample size.","nonInferiorityType":"SUPERIORITY","pValue":"0.7407","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-2.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.2","ciUpperLimit":"10.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"6.1"}]},{"type":"SECONDARY","title":"Study 2 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)","description":"Secondary confirmatory outcome (Study 2): Visual analogue scale rating of food preoccupation during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater food preoccupation.","populationDescription":"Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation.\n\nThe goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline","groups":[{"id":"OG000","title":"Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"OG001","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60.\n\nThe primary goal of the 12-week withdrawal trial (Study 2) was to compare individuals who had discontinued semaglutide at week 60 (by being randomly assigned to switch to placebo at that time) to those who had never taken active medication (Continuous Placebo group), in order to evaluate whether those who discontinued medication were significantly worse off, in terms of appetite, than those who had never been exposed to the medication at week 72.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis."},{"id":"OG002","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42.7","spread":"5.0"},{"groupId":"OG001","value":"62.9","spread":"3.5"},{"groupId":"OG002","value":"26.4","spread":"7.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared the week 72 endpoint controlling for baseline values (week 0 of study 1) between the Switched to Placebo and Continuous Placebo groups.\n\nThe Continued Medication group was used for blinding and not intended for statistical comparison. Continued Medication participants may appear different by chance due to small sample size.","nonInferiorityType":"SUPERIORITY","pValue":"0.0017","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-20.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-32.6","ciUpperLimit":"-8.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"6.1"}]},{"type":"SECONDARY","title":"Study 2 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)","description":"Secondary confirmatory outcome (Study 2): Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version). Score range 1-5. Higher scores indicate greater responsiveness to the food environment.","populationDescription":"Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation.\n\nThe goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline","groups":[{"id":"OG000","title":"Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"OG001","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60.\n\nThe primary goal of the 12-week withdrawal trial (Study 2) was to compare individuals who had discontinued semaglutide at week 60 (by being randomly assigned to switch to placebo at that time) to those who had never taken active medication (Continuous Placebo group), in order to evaluate whether those who discontinued medication were significantly worse off, in terms of appetite, than those who had never been exposed to the medication at week 72.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis."},{"id":"OG002","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"0.2"},{"groupId":"OG001","value":"2.5","spread":"0.1"},{"groupId":"OG002","value":"1.7","spread":"0.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared the week 72 endpoint controlling for baseline values (week 0 of study 1) between the Switched to Placebo and Continuous Placebo groups.\n\nThe Continued Medication group was used for blinding and not intended for statistical comparison. Continued Medication participants may appear different by chance due to small sample size.","nonInferiorityType":"SUPERIORITY","pValue":"0.1237","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.8","ciUpperLimit":"0.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.2"}]},{"type":"SECONDARY","title":"Study 2 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task","description":"Secondary confirmatory outcome (Study 2): Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task. Scores range from -100 to +100 with higher scores indicating a greater implicit wanting of high-fat savory foods.","populationDescription":"Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation.\n\nThe goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline","groups":[{"id":"OG000","title":"Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"OG001","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60.\n\nThe primary goal of the 12-week withdrawal trial (Study 2) was to compare individuals who had discontinued semaglutide at week 60 (by being randomly assigned to switch to placebo at that time) to those who had never taken active medication (Continuous Placebo group), in order to evaluate whether those who discontinued medication were significantly worse off, in terms of appetite, than those who had never been exposed to the medication at week 72.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis."},{"id":"OG002","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.6","spread":"4.8"},{"groupId":"OG001","value":"-7.2","spread":"3.0"},{"groupId":"OG002","value":"-2.9","spread":"8.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared the week 72 endpoint controlling for baseline values (week 0 of study 1) between the Switched to Placebo and Continuous Placebo groups.\n\nThe Continued Medication group was used for blinding and not intended for statistical comparison. Continued Medication participants may appear different by chance due to small sample size.","nonInferiorityType":"SUPERIORITY","pValue":"0.044","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"11.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.3","ciUpperLimit":"23.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.7"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Ratings of Nausea When Fasting","description":"Exploratory outcome (Study 1): Ratings of nausea using 100 mm visual analogue scales when fasting in the laboratory prior to consuming the standard breakfast meal. Score range 0-100 mm; higher scores indicate greater nausea.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"4.3"},{"groupId":"OG001","value":"7.6","spread":"3.0"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"4.8"},{"groupId":"OG001","value":"0.7","spread":"3.1"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"0.4","spread":"5.1"},{"groupId":"OG001","value":"0.8","spread":"3.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.195","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-6.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.1","ciUpperLimit":"3.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.2"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.807","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.2","ciUpperLimit":"9.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.4"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.941","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.9","ciUpperLimit":"11.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.7"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Ratings of Food Palatability","description":"Exploratory outcome (Study 1): Ratings of food palatability using 100 mm visual analogue scales during a laboratory test meal. Score range 0-100 mm; higher scores indicate higher liking of the food taste.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-1.9","spread":"2.2"},{"groupId":"OG001","value":"-9.8","spread":"2.2"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"3.7"},{"groupId":"OG001","value":"-11.8","spread":"2.5"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-6.2","spread":"3.2"},{"groupId":"OG001","value":"-10.1","spread":"2.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.033","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"7.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.7","ciUpperLimit":"15.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.6"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.021","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"10.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.6","ciUpperLimit":"19.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.4"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.333","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"3.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.0","ciUpperLimit":"11.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.9"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Body Image Dissatisfaction (Body Satisfaction Scale)","description":"Exploratory outcome (Study 1): Body image dissatisfaction (Body Satisfaction Scale). Mean of 13 items, score range 1-7, higher scores indicate greater body part dissatisfaction.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.2"},{"groupId":"OG001","value":"-0.6","spread":"0.1"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.2"},{"groupId":"OG001","value":"-1.0","spread":"0.1"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.2"},{"groupId":"OG001","value":"-1.1","spread":"0.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.158","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1","ciUpperLimit":"0.7","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.2"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.034","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.03","ciUpperLimit":"0.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.2"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.041","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.02","ciUpperLimit":"1.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.3"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 1 Weight-related Self Stigmatization","description":"Exploratory outcome (Study 1): Weight-related self stigmatization by the Weight Bias Internalization Scale. Mean of 11 items; score range 1-7; higher scores indicate greater weight-related self-stigmatization.","populationDescription":"Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"S1: Change from baseline to weeks 20, 40, and 60","groups":[{"id":"OG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60."},{"id":"OG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"72"}]}],"classes":[{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.1"},{"groupId":"OG001","value":"-0.4","spread":"0.1"}]}]},{"title":"Week 40","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"0.2"},{"groupId":"OG001","value":"-0.7","spread":"0.1"}]}]},{"title":"Week 60","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.2"},{"groupId":"OG001","value":"-0.9","spread":"0.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 20 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.879","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.3","ciUpperLimit":"0.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.2"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 40 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.022","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.1","ciUpperLimit":"0.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.2"},{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared mean change at week 60 controlling for baseline values.","nonInferiorityType":"SUPERIORITY","pValue":"0.087","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1","ciUpperLimit":"0.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.3"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Study 2 Body Weight (kg)","description":"Supportive secondary outcome (Study 2): Body weight (kg) at week 72","populationDescription":"Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation.\n\nThe goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"S2: Week 72 endpoint controlling for S1 baseline","groups":[{"id":"OG000","title":"Continuous Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.\n\nAt week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group)."},{"id":"OG001","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60. The primary goal of the 12-week withdrawal trial (Study 2) was to compare individuals who had discontinued semaglutide at week 60 (by being randomly assigned to switch to placebo at that time) to those who had never taken active medication (Continuous Placebo group), in order to evaluate whether those who discontinued medication were significantly worse off, in terms of appetite, than those who had never been exposed to the medication at week 72. By re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis."},{"id":"OG002","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide. By re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"98.3","spread":"2.1"},{"groupId":"OG001","value":"88.9","spread":"1.3"},{"groupId":"OG002","value":"85.3","spread":"3.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analyses compared the week 72 endpoint controlling for baseline values (week 0 of study 1) between the Switched to Placebo and Continuous Placebo groups.\n\nThe Continued Medication group was used for blinding and not intended for statistical comparison. Continued Medication participants may appear different by chance due to small sample size.","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"9.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.5","ciUpperLimit":"14.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.4"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From enrollment until end of treatment, up to 72 weeks","eventGroups":[{"id":"EG000","title":"Behavioral Treatment + Placebo (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.","deathsNumAffected":0,"deathsNumAtRisk":48,"seriousNumAffected":0,"seriousNumAtRisk":48,"otherNumAffected":42,"otherNumAtRisk":48},{"id":"EG001","title":"Behavioral Treatment + Medication (Weeks 0-60)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.","deathsNumAffected":0,"deathsNumAtRisk":72,"seriousNumAffected":3,"seriousNumAtRisk":72,"otherNumAffected":70,"otherNumAtRisk":72},{"id":"EG002","title":"Continuous Placebo (Weeks 60-72)","description":"At week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group).","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":6,"otherNumAtRisk":20},{"id":"EG003","title":"Medication (Semaglutide) Switched to Placebo (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis.","deathsNumAffected":0,"deathsNumAtRisk":43,"seriousNumAffected":0,"seriousNumAtRisk":43,"otherNumAffected":17,"otherNumAtRisk":43},{"id":"EG004","title":"Continued Medication (Semaglutide) (Weeks 60-72)","description":"Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.\n\nAt week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide.\n\nBy re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance.","deathsNumAffected":0,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":3,"otherNumAtRisk":10}],"seriousEvents":[{"term":"Bronchitis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Appendicitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAtRisk":48},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAtRisk":48},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":48},{"groupId":"EG001","numAffected":53,"numAtRisk":72},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":48},{"groupId":"EG001","numAffected":38,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":43},{"groupId":"EG004","numAffected":1,"numAtRisk":10}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":48},{"groupId":"EG001","numAffected":27,"numAtRisk":72},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":2,"numAtRisk":10}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":48},{"groupId":"EG001","numAffected":24,"numAtRisk":72},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":48},{"groupId":"EG001","numAffected":23,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":48},{"groupId":"EG001","numAffected":23,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48},{"groupId":"EG001","numAffected":25,"numAtRisk":72},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":43},{"groupId":"EG004","numAffected":1,"numAtRisk":10}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":48},{"groupId":"EG001","numAffected":17,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":1,"numAtRisk":10}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48},{"groupId":"EG001","numAffected":17,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":1,"numAtRisk":10}]},{"term":"COVID-19","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":48},{"groupId":"EG001","numAffected":13,"numAtRisk":72},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":48},{"groupId":"EG001","numAffected":11,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Gastroenteritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48},{"groupId":"EG001","numAffected":12,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":48},{"groupId":"EG001","numAffected":11,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Musculoskeletal injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":48},{"groupId":"EG001","numAffected":8,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48},{"groupId":"EG001","numAffected":9,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Musculoskeletal pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48},{"groupId":"EG001","numAffected":8,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48},{"groupId":"EG001","numAffected":6,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":1,"numAtRisk":10}]},{"term":"Injection site bruising","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":48},{"groupId":"EG001","numAffected":4,"numAtRisk":72},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Alopecia","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48},{"groupId":"EG001","numAffected":7,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48},{"groupId":"EG001","numAffected":6,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48},{"groupId":"EG001","numAffected":5,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Depressed mood","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48},{"groupId":"EG001","numAffected":5,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48},{"groupId":"EG001","numAffected":4,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Thirst","organSystem":"General disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48},{"groupId":"EG001","numAffected":4,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48},{"groupId":"EG001","numAffected":4,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Injection site pain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48},{"groupId":"EG001","numAffected":0,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 29.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48},{"groupId":"EG001","numAffected":0,"numAtRisk":72},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":43},{"groupId":"EG004","numAffected":0,"numAtRisk":10}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Jena Shaw Tronieri, PI","organization":"University of Pennsylvania","email":"jenashaw@mail.med.upenn.edu","phone":"2157465045"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2024-02-10","uploadDate":"2026-03-27T13:46","filename":"Prot_SAP_000.pdf","size":777113}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2026-04-20","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"},{"id":"D001835","term":"Body Weight"},{"id":"D015431","term":"Weight Loss"},{"id":"D050177","term":"Overweight"},{"id":"D009043","term":"Motor Activity"},{"id":"D001836","term":"Body Weight Changes"},{"id":"D001070","term":"Appetitive Behavior"}],"ancestors":[{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D001522","term":"Behavior, Animal"}]},"interventionBrowseModule":{"meshes":[{"id":"D001521","term":"Behavior Therapy"},{"id":"D004304","term":"Dosage Forms"},{"id":"C000591245","term":"semaglutide"}],"ancestors":[{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"},{"id":"D004364","term":"Pharmaceutical Preparations"},{"id":"D013678","term":"Technology, Pharmaceutical"},{"id":"D008919","term":"Investigative Techniques"}]}},"hasResults":true}