{"protocolSection":{"identificationModule":{"nctId":"NCT04019197","orgStudyIdInfo":{"id":"STUDY20190121"},"secondaryIdInfos":[{"id":"R01DK121619","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DK121619"}],"organization":{"fullName":"Case Western Reserve University","class":"OTHER"},"briefTitle":"Effects of Semaglutide in HIV-Associated Lipohypertrophy","officialTitle":"Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy"},"statusModule":{"statusVerifiedDate":"2026-04","overallStatus":"ACTIVE_NOT_RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-05-16","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-04-30","type":"ACTUAL"},"completionDateStruct":{"date":"2026-09-01","type":"ESTIMATED"},"studyFirstSubmitDate":"2019-07-01","studyFirstSubmitQcDate":"2019-07-11","studyFirstPostDateStruct":{"date":"2019-07-15","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-10-22","resultsFirstSubmitQcDate":"2026-02-13","resultsFirstPostDateStruct":{"date":"2026-02-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-14","lastUpdatePostDateStruct":{"date":"2026-05-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Case Western Reserve University","class":"OTHER"},"collaborators":[{"name":"Medical University of South Carolina","class":"OTHER"},{"name":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a randomized, double-blinded, placebo-controlled trial designed to assess the effect of the GLP-1 receptor agonist, semaglutide, on visceral and ectopic fat, insulin resistance, inflammation markers, and the downstream effect of cardiovascular risk in people with HIV. The primary endpoints will be visceral and ectopic fat changes over the study period. The secondary endpoints will include changes in markers of inflammation, immune activation, gut integrity, and cardiovascular disease risk assessment.","detailedDescription":"This study is a phase IIb, randomized, double-blinded, placebo-controlled clinical trial of semaglutide in people with HIV-associated lipohypertrophy. Participants will be recruited from 1 site (Cleveland, OH). The duration of the study will be 56 weeks. The interventional phase will last 32 weeks, followed by a 24-week observational phase to assess the sustainability of the intervention. Participants will be randomized 1:1 to receive semaglutide by subcutaneous injection once weekly for 32 weeks (8-week dose escalation phase followed by full-dose for 24 weeks) or matching placebo. The primary objective of this clinical trial is to determine the efficacy of semaglutide in treating lipohypertrophy among non-diabetic people living with HIV by reducing fat accumulation and ectopic fat deposition, altering adipokine levels, improving endothelial function and arterial stiffness, down-regulating key pro-inflammatory cytokines and immune activation without modifying microbial translocation and gut integrity markers."},"conditionsModule":{"conditions":["HIV/AIDS","Lipohypertrophy","Obesity"],"keywords":["HIV","lipohypertrophy","semaglutide","GLP-1 receptor agonist","obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":108,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Participants with HIV and lipohypertrophy: semaglutide arm","type":"EXPERIMENTAL","description":"Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.","interventionNames":["Drug: Semaglutide Injectable Product"]},{"label":"Participants with HIV and lipohypertrophy: placebo arm","type":"PLACEBO_COMPARATOR","description":"Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Semaglutide Injectable Product","description":"semaglutide subcutaneous injection","armGroupLabels":["Participants with HIV and lipohypertrophy: semaglutide arm"],"otherNames":["semaglutide","Ozempic"]},{"type":"DRUG","name":"Placebo","description":"placebo injection","armGroupLabels":["Participants with HIV and lipohypertrophy: placebo arm"],"otherNames":["placebo injection","placebos"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of abdominal fat (total, subcutaneous, visceral) as measured in area via abdominal CT scan.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of body fat (total body fat, total limb fat, total trunk fat) as measured in mass via whole-body DXA scan.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes overtime between participants receiving semaglutide vs. placebo, in total pericardial fat as measured by chest CT scan.","timeFrame":"32 weeks"}],"secondaryOutcomes":[{"measure":"Effects of Semaglutide on Liver Fat at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on liver fat as measured by density via abdominal CT scan. (increased density = less fat)","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Quantity of Lean Body Mass at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of lean body mass as measured by whole-body DXA scan.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Quantity of Total Right Psoas Muscle at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of total right psoas muscle as measured in area via CT scan.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the quality of abdominal fat (total, subcutaneous, visceral) as measured by density via CT scan. (less negative = higher quality)","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Quality of Pericardial Fat at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes overtime between participants receiving semaglutide vs. placebo, on the quality of total pericardial fat as measured by density via CT scan. (less negative = higher quality)","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Quality of Total Right Psoas Muscle at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the quality/intermuscular fat content of total right psoas muscle as measured by density via CT scan.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Anthropometric Measurements (Weight) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Anthropometric Measurements (Body Mass Index) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Anthropometric Measurements (Waist Circumference) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Anthropometric Measurements (Waist-to-hip Ratio) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - Fasting Glucose","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - 2-h OGTT Glucose","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Glucose Metabolism (HgA1C%) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Insulin Sensitivity/Resistance (Insulin Levels) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on insulin sensitivity/insulin resistance by assessing insulin levels and HOMA-IR (calculated based on insulin levels and glucose levels)","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Insulin Sensitivity/Resistance (HOMA-IR) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on insulin sensitivity/insulin resistance by assessing insulin levels and HOMA-IR, calculated based on insulin levels and glucose levels with the formula (Fasting insulin, uIU/mL)\\*(Fasting glucose, mg/dL) / 405). Reference levels for HOMA-IR insulin resistance range from 0.5 - 2.9 with higher values suggesting higher insulin resistance.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on lipoprotein profiles.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Vital Signs (Heart Rate) at 32 Weeks Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Vital Signs (Blood Pressure) at 32 Weeks Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Overall Cardiovascular Disease (CVD) Risk at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in overall cardiovascular disease (CVD) risk. 10-year atherosclerotic cardiovascular disease risk was estimated using the American College of Cardiology's atherosclerotic cardiovascular disease risk estimator plus (https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/). 10-year risk for ASCVD is categorized as: Low-risk (\\<5%), Borderline risk (5% to 7.4%), Intermediate risk (7.5% to 19.9%), High risk (≥20%); minimum to maximum values of 0-100% are required to interpret the median 10-year atherosclerotic cardiovascular disease risk.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Dietary Intake at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on dietary intake via comprehensive dietary intake assessments.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Physical Activity at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on physical activity status via comprehensive physical activity assessments \\[International Physical Activity Questionnaire Short Version (physical activity across the previous 7 days)\\]","timeFrame":"32 weeks"},{"measure":"Safety Analyses","description":"Safety of semaglutide in HIV will be investigated, including a comparison between participants receiving semaglutide vs. placebo, on adverse events, side effects, and related safety endpoints.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (sTNFR-I, sTNFR-II, sCD14, sCD163, sVCAM-1, sICAM-1) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on soluble markers of inflammation and immune activation to assess overall level of systemic inflammation.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (D-dimer, hsCRP) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on soluble markers of inflammation and immune activation to assess overall level of systemic inflammation.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (IL-6) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on soluble markers of inflammation and immune activation to assess overall level of systemic inflammation.","timeFrame":"32 weeks"},{"measure":"Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline","description":"Effects of semaglutide on cellular markers of inflammation and immune activation markers will be investigated to assess overall level of systemic immune activation, including a comparison of changes over time between participants receiving semaglutide vs. placebo. Cellular markers of immune activation were measured on cryopreserved PBMCs by flow cytometry. Monocyte subsets were identified based on CD14 and CD16 expression, including CD14+ CD16+ (inflammatory) and CD14dim CD16+ (patrolling) monocytes; activated CD4+ and CD8+ lymphocytes were identified as those expressing both CD38 and human leukocyte antigen (HLA)-DR; senescence/exhaustion was measured among T cells based on expression of CD28 and CD57 (CD28-CD57+) and on positive expression of PD-1. Each individual immune activation marker was quantified as the % of the total population of that particular cellular subset.","timeFrame":"32 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat)","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of total fat, limb fat, and trunk fat as measured in mass via whole-body DXA scan.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Quantity of Pericardial Fat","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of pericardial fat as measured in volume by chest CT scan.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Liver Fat","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on liver fat as measured by density via abdominal CT scan.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Quantity of Lean Body Mass","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of lean body mass as measured by whole-body DXA scan.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Quantity of Total Right Psoas Muscle","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of total right psoas muscle as measured in area via CT scan.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral)","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality of abdominal fat (total, subcutaneous, visceral) as measured by density via CT scan.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Quality of Pericardial Fat","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality of pericardial fat as measured by density via chest CT scan.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Quality of Total Right Psoas Muscle","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality/intermuscular fat content of total right psoas muscle as measured in density via CT scan.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Anthropometric Measurements (Weight, Waist Circumference, Waist-to-hip Ratio)","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on anthropometric measurements.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Glucose Metabolism","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Lipoprotein Profiles","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on lipoprotein profiles and oxidized LDL levels.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Systemic Inflammation","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on soluble markers of inflammation and immune activation markers to assess overall level of systemic inflammation.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Systemic Immune Activation","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on cellular markers of inflammation and immune activation markers to assess overall level of systemic immune activation.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Insulin Sensitivity/Resistance","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on soluble markers of inflammation and immune activation markers by assessing insulin levels, HOMA-IR (calculated based on insulin levels and glucose levels), and timed insulin levels as part of a 4-hour mixed meal tolerance test.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Gut Hormones","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on gut hormones, GIP and GLP-1 levels, by means of a 4-hour mixed-meal tolerance test.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Gut Integrity","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on gut integrity and microbial translocation (e.g., I-FABP, zonulin-1, LPS).","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Resting Energy Expenditure","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on resting energy expenditure by means of indirect calorimetry.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Pulse Wave Velocity","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on pulse wave velocity, a measure of arterial stiffness, as a surrogate measure of cardiovascular disease risk.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on EndoPat","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on EndoPat, a measure of endothelial function, as a surrogate measure of cardiovascular disease risk.","timeFrame":"56 weeks"},{"measure":"Sustainability of Effects of Semaglutide on Coronary Artery Calcium (CAC) Score","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on coronary artery calcium (CAC) score as measured by chest CT scan.","timeFrame":"56 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Male or female, aged ≥18 years.\n2. HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.\n3. Body mass index ≥25 kg/m2.\n4. Waist circumference and waist-to-hip ratio \\>95 cm and \\>0.94 cm, respectively, for men, and \\>94 cm and \\>0.88 cm, respectively, for women occurring in the context of HIV treatment.\n5. Subjective evidence of increased abdominal girth occurring after initiation of HIV treatment.\n6. HIV-1 RNA \\<400 copies/mL for ≥6 months.\n7. Receiving a stable antiretroviral regimen for at least the last 12 weeks prior to study entry with cumulative duration of 1 year of treatment at the time of study entry.\n8. Provision of signed and dated informed consent form and is capable of reading and comprehending the informed consent.\n9. Stated willingness to comply with all study procedures and availability for the duration of the study.\n10. All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea 12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level 35 mIU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered of child-bearing potential.\n11. Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, bilateral oophorectomy or tubal ligation) or whose male partner has undergone successful vasectomy with resulting azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Patient-reported history of menopause, sterilization, and azoospermia is considered acceptable documentation.\n12. All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female subject/male partner must use condoms (male or female) in addition to one of the following forms of contraception while on study: either a spermicidal agent, diaphragm, cervical cap, IUD, or hormonal-based contraception.\n13. Have no plans to alter antiretroviral therapy, or to undergo any weight loss program, formal exercise training or surgery during the study period, or initiate structured/strategic antiretroviral treatment interruptions.\n\nExclusion Criteria:\n\n1. Known cardiovascular disease or diagnosed diabetes. If on metformin without a diabetes diagnoses metformin use has to be constant, uninterrupted for 6 months prior to entry.\n2. Any active or chronic uncontrolled inflammatory condition, infection or cancer.\n3. Women who are pregnant or breastfeeding.\n4. Women with a positive pregnancy test on enrollment or prior to study drug administration.\n5. A clinically-relevant illness within 14 days prior to study entry not explicitly excluded by the protocol, a physical or psychiatric disability, or a laboratory abnormality that might place the subject at increased risk by being exposed to the medications in this study or which might confound the interpretation of this investigation.\n6. Active gastrointestinal symptom Grade \\>1 within the last month.\n7. Regular use of immunomodulators/agents which could impact inflammation. Regular use of NSAIDS allowed if constant, uninterrupted for 6 months and no plans to alter. Statin use must also be constant, uninterrupted for 6 months prior to study entry. Thyroid medication allowed unless diagnosed with uncontrolled thyroid disease.\n8. Inability to communicate effectively with study personnel.\n9. Use of megestrol acetate, testosterone, or any steroid use beyond normal amounts found in the body within 6 months of study, or intend to start.\n10. Glomerular filtration rate \\<50 cc/min/1.73 m2.\n11. Hemoglobin \\<10 g/dL.\n12. Elevated lipase level \\>1.5 upper limit of normal\n13. AST AND ALT \\>2.5x upper limit of normal.\n14. Use of growth hormone or growth hormone-releasing hormone in the last year, or intent to start.\n15. History of excessive alcohol use (on average 2 or more drinks a day) , pancreatitis, thyroid cancer, or a diagnosis of multiple endocrine neoplasia (MEN) syndrome type 2.\n16. History of lactose intolerance or inability to consume milk products will be exclusionary for participation in the mixed-meal tolerance test portion of the study.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Grace A McComsey, MD","affiliation":"Case Western Reserve University","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Allison R Eckard, MD","affiliation":"Medical University of South Carolina","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Case Western Reserve University","city":"Cleveland","state":"Ohio","zip":"44106","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","zip":"29425","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}}]},"referencesModule":{"references":[{"pmid":"42752515","type":"DERIVED","citation":"Daher J, Koberssy Z, Moussallem N, Wu Q, Sattar A, Fletcher AA, McComsey CM, Funderburg NT, Ailstock K, Eckard AR. Effects of semaglutide on subclinical cardiovascular health in people with HIV. AIDS. 2026 Sep 17. doi: 10.1097/QAD.0000000000004624. Online ahead of print."},{"pmid":"41098140","type":"DERIVED","citation":"Atieh O, Daher J, Abboud M, Wu Q, Sattar A, Baissary J, Koberssy Z, Labbato D, Eckard AR, McComsey GA. Effects of Semaglutide on Cognitive Function in People With HIV: A Randomized, Controlled Trial. Clin Infect Dis. 2026 May 20;82(5):753-761. doi: 10.1093/cid/ciaf577."},{"pmid":"40160348","type":"DERIVED","citation":"Funderburg NT, Ross Eckard A, Wu Q, Sattar A, Ailstock K, Cummings M, Labbato D, McComsey GA. The Effects of Semaglutide on Inflammation and Immune Activation in HIV-associated Lipohypertrophy. Open Forum Infect Dis. 2025 Mar 20;12(4):ofaf152. doi: 10.1093/ofid/ofaf152. eCollection 2025 Apr."},{"pmid":"38964353","type":"DERIVED","citation":"Eckard AR, Wu Q, Sattar A, Ansari-Gilani K, Labbato D, Foster T, Fletcher AA, Adekunle RO, McComsey GA. Once-weekly semaglutide in people with HIV-associated lipohypertrophy: a randomised, double-blind, placebo-controlled phase 2b single-centre clinical trial. Lancet Diabetes Endocrinol. 2024 Aug;12(8):523-534. doi: 10.1016/S2213-8587(24)00150-5. Epub 2024 Jul 1."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Sharing of data generated by this project is an essential part of our proposed activities and will be carried out to comply with the NIH policy on Sharing Research Data. We wish to make our results available both to the community of scientists interested in HIV infection, immune activation and co-morbidities, as well as to people living with HIV infection. The data generated in this project will be presented at local, national and international conferences and published in peer-reviewed journals in a timely fashion. All final peer-reviewed manuscripts that arise from this project will be submitted to PubMed Central. The PI will work to facilitate any request made for data produced under this proposal upon publication of data, using standard, university-approved material/data transfer agreements.","timeFrame":"after completion of total study and publication","accessCriteria":"individual requests will be reviewed by study PIs."}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Participants With HIV and Lipohypertrophy: Semaglutide Arm","description":"Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.\n\nSemaglutide Injectable Product: semaglutide subcutaneous injection"},{"id":"FG001","title":"Participants With HIV and Lipohypertrophy: Placebo Arm","description":"Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.\n\nPlacebo: placebo injection"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"total number assessed for eligibility","numSubjects":"54"},{"groupId":"FG001","comment":"total number assessed for eligibility","numSubjects":"54"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"primary completion date at study week 32","numSubjects":"46"},{"groupId":"FG001","comment":"primary completion date at study week 32","numSubjects":"46"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"8"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by 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cm^2","categories":[{"measurements":[{"groupId":"OG000","value":"-9.45","lowerLimit":"-25.80","upperLimit":"3.00"},{"groupId":"OG001","value":"2.60","lowerLimit":"-13.60","upperLimit":"19.60"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quantity of Abdominal Total Adipose Tissue, cm\\^2","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"<0.0001","statisticalMethod":"linear combination of regression coeff.","paramType":"β 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0.0989."},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quantity of Abdominal Visceral Adipose Tissue, cm\\^2","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.0017","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-30.83","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-50.13","ciUpperLimit":"-11.51","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"9.85","estimateComment":"Estimated % change = -30.6% (calculated from the final fitted model using the formula, 100(β/regression intercept))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"PRIMARY","title":"Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of body fat (total body fat, total limb fat, total trunk fat) as measured in mass via whole-body DXA scan.","populationDescription":"absolute changes for primary outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"kg","timeFrame":"32 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kg","categories":[{"measurements":[{"groupId":"OG000","value":"-2.86","lowerLimit":"-4.47","upperLimit":"-1.40"},{"groupId":"OG001","value":"0.17","lowerLimit":"-1.22","upperLimit":"1.27"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quantity of ln(Total Body Fat, kg)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0009","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.33","ciUpperLimit":"-0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"-18.9","estimateComment":"Estimated % change = -18.9% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quantity of ln(Total Limb Fat, kg)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0065","statisticalMethod":"[linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.32","ciUpperLimit":"-0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.07","estimateComment":"Estimated % change = -17.3% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quantity of ln(Trunk Fat, kg)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"<0.0001","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"-0.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.37","ciUpperLimit":"-0.11","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.07","estimateComment":"Estimated % change = -18.9% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"PRIMARY","title":"Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes overtime between participants receiving semaglutide vs. placebo, in total pericardial fat as measured by chest CT scan.","populationDescription":"absolute changes over 32 weeks in each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mL","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.85","lowerLimit":"-17.90","upperLimit":"11.00"},{"groupId":"OG001","value":"0.00","lowerLimit":"-10.30","upperLimit":"10.40"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quantity of ln(Pericardial Fat, mL)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.13","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.41","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.12","estimateComment":"Estimated % change = -16.5% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Liver Fat at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on liver fat as measured by density via abdominal CT scan. 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p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Quantity of Lean Body Mass at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of lean body mass as measured by whole-body DXA scan.","populationDescription":"absolute changes in lean body mass over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"kg","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to the semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to the placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.94","lowerLimit":"-3.89","upperLimit":"-1.49"},{"groupId":"OG001","value":"-0.17","lowerLimit":"-11.61","upperLimit":"0.66"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quantity of Lean Body Mass, kg","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.13","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-2.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.83","ciUpperLimit":"0.83","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.96","estimateComment":"Estimated % change = -5.7% (calculated from the final fitted models using the formula 100(β/regression intercept)","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Quantity of Total Right Psoas Muscle at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of total right psoas muscle as measured in area via CT scan.","populationDescription":"absolute changes in total right psoas muscle in each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"cm^2","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to the semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to the placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.10","lowerLimit":"-1.90","upperLimit":"1.00"},{"groupId":"OG001","value":"-0.20","lowerLimit":"-2.70","upperLimit":"2.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quantity of ln(Total Right Psoas Muscle, cm\\^2)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.69","statisticalMethod":"[linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.15","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.05","estimateComment":"Estimated % change = -5.3% (calculated from the final fitted models using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the quality of abdominal fat (total, subcutaneous, visceral) as measured by density via CT scan. (less negative = higher quality)","populationDescription":"absolute changes in quality of abdominal fat for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Hounsfield units","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to the semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to the placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"title":"Abdominal total adipose tissue, Hounsfield unit","categories":[{"measurements":[{"groupId":"OG000","value":"0.40","lowerLimit":"-2.30","upperLimit":"2.50"},{"groupId":"OG001","value":"6.65","lowerLimit":"-18.90","upperLimit":"42.50"}]}]},{"title":"Abdominal subcutaneous adipose tissue, Hounsfield unit","categories":[{"measurements":[{"groupId":"OG000","value":"-34.65","lowerLimit":"-64.40","upperLimit":"-12.40"},{"groupId":"OG001","value":"3.90","lowerLimit":"-15.00","upperLimit":"20.20"}]}]},{"title":"Abdominal visceral adipose tissue, Hounsfield unit","categories":[{"measurements":[{"groupId":"OG000","value":"-9.45","lowerLimit":"-25.80","upperLimit":"3.00"},{"groupId":"OG001","value":"2.60","lowerLimit":"-13.60","upperLimit":"19.60"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quality of Abdominal Total Adipose Tissue, HU (higher density = higher quality)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.58","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"0.52","ciPctValue":"-1.30","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.39","ciUpperLimit":"2.33","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.93","estimateComment":"Estimated % change = 0.60% (calculated from the final fitted model using the formulas 100(β/regression intercept))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quality of Abdominal Subcutaneous Adipose Tissue, HU (higher density = higher quality)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.90","statisticalMethod":"[linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.05","ciUpperLimit":"1.82","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.93","estimateComment":"Estimated % change = 0.10% (calculated from the final fitted model using the formulas 100(β/regression intercept))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quality of Abdominal Visceral Adipose Tissue, HU (less negative = higher quality)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.0031","statisticalMethod":"linear combination of regression coeff.","statisticalComment":"β coefficient","paramType":"β coefficient","paramValue":"3.70","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.25","ciUpperLimit":"6.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.25","estimateComment":"Estimated % change = -4.4% (calculated from the final fitted model using the formulas 100(β/regression intercept))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Quality of Pericardial Fat at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes overtime between participants receiving semaglutide vs. placebo, on the quality of total pericardial fat as measured by density via CT scan. (less negative = higher quality)","populationDescription":"absolute changes in quality of a total pericardial fat for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Hounsfield units","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.20","lowerLimit":"-0.90","upperLimit":"1.10"},{"groupId":"OG001","value":"0.00","lowerLimit":"-1.40","upperLimit":"0.30"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quality of Pericardial Fat, HU (higher density = higher quality)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.17","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"0.80","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.33","ciUpperLimit":"1.93","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.57","estimateComment":"Estimated % change = -0.7% (calculated from the final fitted model using the formulas 100(β/regression intercept))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Quality of Total Right Psoas Muscle at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the quality/intermuscular fat content of total right psoas muscle as measured by density via CT scan.","populationDescription":"absolute changes in right psoas muscle density","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Hounsfield units","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.10","lowerLimit":"-1.90","upperLimit":"1.00"},{"groupId":"OG001","value":"-0.20","lowerLimit":"-2.70","upperLimit":"2.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Quality of Total Right Psoas Muscle, HU","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.69","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.02","ciUpperLimit":"1.99","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.28","estimateComment":"Estimated % change = 0.60% (calculated from the final fitted model using the formulas 100(β/regression intercept))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Anthropometric Measurements (Weight) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.","populationDescription":"absolute changes for outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"kg","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to the semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to the placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.82","lowerLimit":"-11.88","upperLimit":"-3.90"},{"groupId":"OG001","value":"0.16","lowerLimit":"-2.54","upperLimit":"2.59"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(Weight, kg)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0057","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.19","ciUpperLimit":"-0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.04","estimateComment":"Estimated % change = -10.4% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Anthropometric Measurements (Body Mass Index) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.","populationDescription":"absolute changes for outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"kg/m^2","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to the semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to the placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.64","lowerLimit":"-4.00","upperLimit":"-1.37"},{"groupId":"OG001","value":"-0.02","lowerLimit":"-1.05","upperLimit":"0.66"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Body Mass Index, kg/m2","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.0018","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-4.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.77","ciUpperLimit":"-1.54","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.33","estimateComment":"Estimated % change = -11.2 (calculated from the final fitted model using the formula 100(β/regression intercept))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Anthropometric Measurements (Waist Circumference) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.","populationDescription":"absolute changes for outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"cm","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to the semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to the placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.50","lowerLimit":"-11.17","upperLimit":"-0.50"},{"groupId":"OG001","value":"0.17","lowerLimit":"-2.33","upperLimit":"2.67"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Waist Circumference, cm","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"<0.0001","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-9.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.55","ciUpperLimit":"-4.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.67","estimateComment":"Estimated % change = -8.3% (calculated from the final fitted model using the formula 100(β/regression intercept))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Anthropometric Measurements (Waist-to-hip Ratio) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.","populationDescription":"absolute changes for outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"ratio","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to the semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to the placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.01","lowerLimit":"-0.04","upperLimit":"0.02"},{"groupId":"OG001","value":"-0.01","lowerLimit":"-0.05","upperLimit":"0.02"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(Waist-to-Hip Ratio)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0854","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.05","ciUpperLimit":"0.00","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.01","estimateComment":"Estimated % change = -2.3% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - Fasting Glucose","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.","populationDescription":"absolute changes for outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/dL","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.50","lowerLimit":"-5.00","upperLimit":"7.00"},{"groupId":"OG001","value":"0.00","lowerLimit":"-11.00","upperLimit":"9.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(Fasting Glucose)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.14","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.09","ciUpperLimit":"0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.02","estimateComment":"Estimated % change = -3.6% (calculated from the final fitted model using the formula 100(eβ-1))"}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - 2-h OGTT Glucose","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.","populationDescription":"absolute changes for outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/mL","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.50","lowerLimit":"-41.50","upperLimit":"2.00"},{"groupId":"OG001","value":"-2.00","lowerLimit":"-16.00","upperLimit":"16.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on 2-h OGTT Glucose","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.0324","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-18.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-34.50","ciUpperLimit":"-1.50","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"8.42","estimateComment":"Estimated % change = -15.5% (calculated from the final fitted model using the formula 100(β regression intercept))"}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Glucose Metabolism (HgA1C%) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.","populationDescription":"absolute changes for outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"% of glycosylated hemoglobin","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.20","lowerLimit":"-0.60","upperLimit":"-0.10"},{"groupId":"OG001","value":"0.10","lowerLimit":"-0.10","upperLimit":"0.20"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on HbA1C %","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"<0.0001","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.67","ciUpperLimit":"-0.28","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.10","estimateComment":"Estimated % change = -8.5% (calculated from the final fitted model using the formula 100(β/regression intercept))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Insulin Sensitivity/Resistance (Insulin Levels) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on insulin sensitivity/insulin resistance by assessing insulin levels and HOMA-IR (calculated based on insulin levels and glucose levels)","populationDescription":"absolute changes of outcome variables over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"uIU/mL","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"title":"Fasting insulin, uIU/mL","categories":[{"measurements":[{"groupId":"OG000","value":"2.00","lowerLimit":"-3.00","upperLimit":"7.00"},{"groupId":"OG001","value":"-1.00","lowerLimit":"-6.00","upperLimit":"4.00"}]}]},{"title":"2-h OGTT insulin, uIU/mL","categories":[{"measurements":[{"groupId":"OG000","value":"4.50","lowerLimit":"-13.50","upperLimit":"18.50"},{"groupId":"OG001","value":"2.00","lowerLimit":"-18.00","upperLimit":"26.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(Fasting Insulin, uIU/mL)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.91","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.29","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.14","estimateComment":"Estimated % change = 1.6% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(2-h OGTT Insulin, uIU/mL)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0819","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.76","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.21","estimateComment":"Estimated % change = -30.1% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Insulin Sensitivity/Resistance (HOMA-IR) at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on insulin sensitivity/insulin resistance by assessing insulin levels and HOMA-IR, calculated based on insulin levels and glucose levels with the formula (Fasting insulin, uIU/mL)\\*(Fasting glucose, mg/dL) / 405). Reference levels for HOMA-IR insulin resistance range from 0.5 - 2.9 with higher values suggesting higher insulin resistance.","populationDescription":"absolute changes of outcome variables over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"index","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"title":"Fasting HOMA-IR","categories":[{"measurements":[{"groupId":"OG000","value":"0.33","lowerLimit":"-0.76","upperLimit":"1.93"},{"groupId":"OG001","value":"-0.37","lowerLimit":"-1.58","upperLimit":"0.86"}]}]},{"title":"2-h OGTT HOMA-IR","categories":[{"measurements":[{"groupId":"OG000","value":"-0.29","lowerLimit":"-6.94","upperLimit":"3.98"},{"groupId":"OG001","value":"1.30","lowerLimit":"-6.26","upperLimit":"7.19"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(Fasting HOMA-IR)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.89","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.31","ciUpperLimit":"0.27","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.15","estimateComment":"Estimated % change = -2.1% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(2-h OGTT HOMA-IR)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0238","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"-0.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.05","ciUpperLimit":"-0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.25","estimateComment":"Estimated % change = -43.0% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on lipoprotein profiles.","populationDescription":"absolute changes in outcome variable over 32 weeks in each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/dL","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to the semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to the placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"title":"Total cholesterol, mg/dL","categories":[{"measurements":[{"groupId":"OG000","value":"-12.5","lowerLimit":"-28.00","upperLimit":"-3.00"},{"groupId":"OG001","value":"-10.50","lowerLimit":"-27.00","upperLimit":"7.00"}]}]},{"title":"High-density lipoprotein cholesterol, mg/dL","categories":[{"measurements":[{"groupId":"OG000","value":"-2.50","lowerLimit":"-6.30","upperLimit":"2.20"},{"groupId":"OG001","value":"-1.60","lowerLimit":"-5.3","upperLimit":"3.00"}]}]},{"title":"Low-density lipoprotein cholesterol, mg/dL","categories":[{"measurements":[{"groupId":"OG000","value":"-9.00","lowerLimit":"-21.00","upperLimit":"0.00"},{"groupId":"OG001","value":"-6.00","lowerLimit":"-20.00","upperLimit":"7.00"}]}]},{"title":"Very low-density lipoprotein cholesterol, mg/dL","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","lowerLimit":"-7.00","upperLimit":"3.00"},{"groupId":"OG001","value":"-2.00","lowerLimit":"-10.00","upperLimit":"6.00"}]}]},{"title":"Triglycerides, mg/dL","categories":[{"measurements":[{"groupId":"OG000","value":"-1.00","lowerLimit":"-33.00","upperLimit":"14.00"},{"groupId":"OG001","value":"-13.00","lowerLimit":"-50.00","upperLimit":"25.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Total Cholesterol, mg/dL","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.35","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"-7.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-22.20","ciUpperLimit":"7.85","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"7.67","estimateComment":"Estimated % change = -18.9% (calculated from the final fitted model using the formula 100(β/regression intercept)"},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Low-Density Lipoprotein Cholesterol, mg/dL","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time.","pValue":"0.54","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-4.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.72","ciUpperLimit":"9.25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"6.88","estimateComment":"Estimated % change = -3.7% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(High-Density Lipoprotein Cholesterol, mg/dL)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0989","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.01","ciUpperLimit":"0.17","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.05","estimateComment":"Estimated % change = -8.1% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(Very Low-Density Lipoprotein Cholesterol, mg/dL)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0375","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"-0.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.39","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.10","estimateComment":"Estimated % change = -18.0% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(Triglycerides, mg/dL)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0220","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.43","ciUpperLimit":"-0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.10","estimateComment":"Estimated % change = -20.7% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Vital Signs (Heart Rate) at 32 Weeks Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs.","populationDescription":"absolute changes in outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"beats/minute","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.50","lowerLimit":"-9.00","upperLimit":"10.00"},{"groupId":"OG001","value":"2.00","lowerLimit":"-6.00","upperLimit":"8.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Heart Rate","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.90","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.39","ciUpperLimit":"4.73","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.58","estimateComment":"Estimated % change = -0.4% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Vital Signs (Blood Pressure) at 32 Weeks Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs.","populationDescription":"absolute changes in outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mmHg","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"title":"Systolic blood pressure, mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"-4.00","lowerLimit":"-15.00","upperLimit":"7.00"},{"groupId":"OG001","value":"1.00","lowerLimit":"-7.00","upperLimit":"9.00"}]}]},{"title":"Diastolic blood pressure, mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"-1.50","lowerLimit":"-7.00","upperLimit":"2.00"},{"groupId":"OG001","value":"3.50","lowerLimit":"-6.00","upperLimit":"8.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on Systolic blood pressure","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0203","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.10","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.02","estimateComment":"Estimated % change = -5.2% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on diastolic blood pressure","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.50","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"-1.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.67","ciUpperLimit":"2.26","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.77","estimateComment":"Estimated % change = -1.5% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Overall Cardiovascular Disease (CVD) Risk at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in overall cardiovascular disease (CVD) risk. 10-year atherosclerotic cardiovascular disease risk was estimated using the American College of Cardiology's atherosclerotic cardiovascular disease risk estimator plus (https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/). 10-year risk for ASCVD is categorized as: Low-risk (\\<5%), Borderline risk (5% to 7.4%), Intermediate risk (7.5% to 19.9%), High risk (≥20%); minimum to maximum values of 0-100% are required to interpret the median 10-year atherosclerotic cardiovascular disease risk.","populationDescription":"absolute changes in 10-year ASCVD risk estimate","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"10-year ASCVD risk estimate %","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.30","lowerLimit":"-1.70","upperLimit":"0.30"},{"groupId":"OG001","value":"0.40","lowerLimit":"-0.60","upperLimit":"1.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on ln(10-Year ASCVD Risk Estimate)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.0264","statisticalMethod":"linear combination of regression coeff.","paramType":"β coefficient","paramValue":"-0.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.74","ciUpperLimit":"-0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.18","estimateComment":"Estimated % change = -32.6% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Dietary Intake at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on dietary intake via comprehensive dietary intake assessments.","populationDescription":"absolute change in Daily estimated total calories, kcal (dietary intake)","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Kcal","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"137.33","lowerLimit":"-240.31","upperLimit":"388.87"},{"groupId":"OG001","value":"17.84","lowerLimit":"-286.92","upperLimit":"386.33"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of Semaglutide on dietary intake","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.45","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"-145.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-522.28","ciUpperLimit":"230.66","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"192.08","estimateComment":"Estimated % change = -10.8% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989."}]},{"type":"SECONDARY","title":"Effects of Semaglutide on Physical Activity at Week 32 Compared to Baseline","description":"Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on physical activity status via comprehensive physical activity assessments \\[International Physical Activity Questionnaire Short Version (physical activity across the previous 7 days)\\]","populationDescription":"absolute changes in estimated weekly physical activity","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"minutes per week","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"title":"Low intensity, minutes per week","categories":[{"measurements":[{"groupId":"OG000","value":"-85.71","lowerLimit":"-100.00","upperLimit":"0.00"},{"groupId":"OG001","value":"-75.00","lowerLimit":"-100.00","upperLimit":"51.14"}]}]},{"title":"Moderate intensity, minutes per week","categories":[{"measurements":[{"groupId":"OG000","value":"-29.17","lowerLimit":"-50.00","upperLimit":"50.00"},{"groupId":"OG001","value":"-25.00","lowerLimit":"-50.00","upperLimit":"60.00"}]}]},{"title":"High intensity, minutes per week","categories":[{"measurements":[{"groupId":"OG000","value":"21.11","lowerLimit":"-32.29","upperLimit":"100.00"},{"groupId":"OG001","value":"0.00","lowerLimit":"-20.00","upperLimit":"50.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Effects of semaglutide on physical activity (low intensity, minutes per week)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.57","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"420","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1012.24","ciUpperLimit":"1852.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"730.75","estimateComment":"Estimated % change = 20% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of semaglutide on physical activity (moderate intensity, minutes per week)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"0.32","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"-420","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1250.71","ciUpperLimit":"410.71","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"423.84","estimateComment":"Estimated % change = -16.7% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"},{"groupIds":["OG000","OG001"],"groupDescription":"Effects of semaglutide on physical activity (high intensity, minutes per week)","nonInferiorityType":"OTHER","nonInferiorityComment":"Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data.","pValue":"1.00","statisticalMethod":"linear combination of regression coeff","paramType":"β coefficient","paramValue":"0.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-163.04","ciUpperLimit":"163.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"83.19","estimateComment":"Estimated % change = 0.0% (calculated from the final fitted model using the formula 100(eβ-1))","otherAnalysisDescription":"Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989"}]},{"type":"SECONDARY","title":"Safety Analyses","description":"Safety of semaglutide in HIV will be investigated, including a comparison between participants receiving semaglutide vs. placebo, on 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Monocyte subsets were identified based on CD14 and CD16 expression, including CD14+ CD16+ (inflammatory) and CD14dim CD16+ (patrolling) monocytes; activated CD4+ and CD8+ lymphocytes were identified as those expressing both CD38 and human leukocyte antigen (HLA)-DR; senescence/exhaustion was measured among T cells based on expression of CD28 and CD57 (CD28-CD57+) and on positive expression of PD-1. Each individual immune activation marker was quantified as the % of the total population of that particular cellular subset.","populationDescription":"absolute changes for outcomes measures over 32 weeks for each group","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"% of cell subset","timeFrame":"32 weeks","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants assigned to semaglutide group"},{"id":"OG001","title":"Placebo","description":"Participants assigned to placebo group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}]}],"classes":[{"title":"Inflammatory monocytes","categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","lowerLimit":"-0.11","upperLimit":"0.05"},{"groupId":"OG001","value":"0.00","lowerLimit":"-0.10","upperLimit":"0.08"}]}]},{"title":"Patrolling monocytes","categories":[{"measurements":[{"groupId":"OG000","value":"-0.01","lowerLimit":"-0.03","upperLimit":"0.01"},{"groupId":"OG001","value":"-0.01","lowerLimit":"-0.04","upperLimit":"0.02"}]}]},{"title":"Activated CD4+ lymphocytes","categories":[{"measurements":[{"groupId":"OG000","value":"0.07","lowerLimit":"-1.93","upperLimit":"3.91"},{"groupId":"OG001","value":"0.92","lowerLimit":"-2.44","upperLimit":"6.47"}]}]},{"title":"Activated CD8+ lymphocytes","categories":[{"measurements":[{"groupId":"OG000","value":"-0.63","lowerLimit":"-4.95","upperLimit":"1.17"},{"groupId":"OG001","value":"0.34","lowerLimit":"-1.98","upperLimit":"3.23"}]}]},{"title":"Exhausted CD4+ lymphocytes","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","lowerLimit":"-0.18","upperLimit":"1.44"},{"groupId":"OG001","value":"0.34","lowerLimit":"-0.01","upperLimit":"1.62"}]}]},{"title":"Exhausted CD8+ lymphocytes","categories":[{"measurements":[{"groupId":"OG000","value":"2.26","lowerLimit":"-9.84","upperLimit":"7.23"},{"groupId":"OG001","value":"4.07","lowerLimit":"-4.39","upperLimit":"11.15"}]}]}]},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat)","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of total fat, limb fat, and trunk fat as measured in mass via whole-body DXA scan.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Quantity of Pericardial Fat","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of pericardial fat as measured in volume by chest CT scan.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Liver Fat","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on liver fat as measured by density via abdominal CT scan.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Quantity of Lean Body Mass","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of lean body mass as measured by whole-body DXA scan.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Quantity of Total Right Psoas Muscle","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of total right psoas muscle as measured in area via CT scan.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral)","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality of abdominal fat (total, subcutaneous, visceral) as measured by density via CT scan.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Quality of Pericardial Fat","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality of pericardial fat as measured by density via chest CT scan.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Quality of Total Right Psoas Muscle","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality/intermuscular fat content of total right psoas muscle as measured in density via CT scan.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Anthropometric Measurements (Weight, Waist Circumference, Waist-to-hip Ratio)","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on anthropometric measurements.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Glucose Metabolism","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.","reportingStatus":"NOT_POSTED","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Lipoprotein Profiles","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on lipoprotein profiles and oxidized LDL levels.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Systemic Inflammation","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on soluble markers of inflammation and immune activation markers to assess overall level of systemic inflammation.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Systemic Immune Activation","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on cellular markers of inflammation and immune activation markers to assess overall level of systemic immune activation.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Insulin Sensitivity/Resistance","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on soluble markers of inflammation and immune activation markers by assessing insulin levels, HOMA-IR (calculated based on insulin levels and glucose levels), and timed insulin levels as part of a 4-hour mixed meal tolerance test.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Gut Hormones","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on gut hormones, GIP and GLP-1 levels, by means of a 4-hour mixed-meal tolerance test.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Gut Integrity","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on gut integrity and microbial translocation (e.g., I-FABP, zonulin-1, LPS).","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Resting Energy Expenditure","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on resting energy expenditure by means of indirect calorimetry.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Pulse Wave Velocity","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on pulse wave velocity, a measure of arterial stiffness, as a surrogate measure of cardiovascular disease risk.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on EndoPat","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on EndoPat, a measure of endothelial function, as a surrogate measure of cardiovascular disease risk.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Sustainability of Effects of Semaglutide on Coronary Artery Calcium (CAC) Score","description":"Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on coronary artery calcium (CAC) score as measured by chest CT scan.","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2027-09","timeFrame":"56 weeks","denomUnitsSelected":"Participants"}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.","description":"All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.","eventGroups":[{"id":"EG000","title":"Participants With HIV and Lipohypertrophy: Semaglutide Arm","description":"Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.\n\nSemaglutide Injectable Product: semaglutide subcutaneous injection","deathsNumAffected":0,"deathsNumAtRisk":54,"seriousNumAffected":1,"seriousNumAtRisk":54,"otherNumAffected":53,"otherNumAtRisk":54},{"id":"EG001","title":"Participants With HIV and Lipohypertrophy: Placebo Arm","description":"Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.\n\nPlacebo: placebo injection","deathsNumAffected":0,"deathsNumAtRisk":54,"seriousNumAffected":0,"seriousNumAtRisk":54,"otherNumAffected":53,"otherNumAtRisk":54}],"seriousEvents":[{"term":"Study-Related Serious Adverse Event","organSystem":"Hepatobiliary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 4 lipase value in asymptomatic participant with no evidence of pancreatitis on abdominal ultrasound","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":54}]}],"otherEvents":[{"term":"Injection Site Reaction","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":54},{"groupId":"EG001","numAffected":2,"numAtRisk":54}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":54},{"groupId":"EG001","numAffected":11,"numAtRisk":54}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":54},{"groupId":"EG001","numAffected":17,"numAtRisk":54}]},{"term":"Elevated Total Bilirubin","organSystem":"Hepatobiliary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":54},{"groupId":"EG001","numAffected":1,"numAtRisk":54}]},{"term":"Anxiety or Nervousness","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":54},{"groupId":"EG001","numAffected":3,"numAtRisk":54}]},{"term":"Bloating or Fullness","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":54},{"groupId":"EG001","numAffected":2,"numAtRisk":54}]},{"term":"Constipation or Irregular Bowel Movements","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":54},{"groupId":"EG001","numAffected":7,"numAtRisk":54}]},{"term":"Decreased Hemoglobin","organSystem":"Blood and lymphatic system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":54},{"groupId":"EG001","numAffected":2,"numAtRisk":54}]},{"term":"Decreased Phosphorus","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":54},{"groupId":"EG001","numAffected":10,"numAtRisk":54}]},{"term":"Decreased Sodium","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":54},{"groupId":"EG001","numAffected":5,"numAtRisk":54}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":54},{"groupId":"EG001","numAffected":2,"numAtRisk":54}]},{"term":"Elevated Alanine Transaminase","organSystem":"Hepatobiliary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":54},{"groupId":"EG001","numAffected":6,"numAtRisk":54}]},{"term":"Elevated Aspartate Transferase","organSystem":"Hepatobiliary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":54},{"groupId":"EG001","numAffected":4,"numAtRisk":54}]},{"term":"Elevated Creatinine","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":54},{"groupId":"EG001","numAffected":14,"numAtRisk":54}]},{"term":"Elevated Glucose","organSystem":"Endocrine disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":54},{"groupId":"EG001","numAffected":39,"numAtRisk":54}]},{"term":"Elevated Lipase","organSystem":"Endocrine disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":54},{"groupId":"EG001","numAffected":5,"numAtRisk":54}]},{"term":"Elevated Potassium","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":54},{"groupId":"EG001","numAffected":5,"numAtRisk":54}]},{"term":"Elevated Uric Acid","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":54},{"groupId":"EG001","numAffected":13,"numAtRisk":54}]},{"term":"Eructation or Flatulence","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":54},{"groupId":"EG001","numAffected":10,"numAtRisk":54}]},{"term":"Fatigue","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":54},{"groupId":"EG001","numAffected":8,"numAtRisk":54}]},{"term":"Gastritis","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":54},{"groupId":"EG001","numAffected":1,"numAtRisk":54}]},{"term":"Headaches","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":54},{"groupId":"EG001","numAffected":10,"numAtRisk":54}]},{"term":"Irritability or Moodiness","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":54},{"groupId":"EG001","numAffected":6,"numAtRisk":54}]},{"term":"Localized Musculoskeletal pain, weakness, swelling, or injury","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":54},{"groupId":"EG001","numAffected":7,"numAtRisk":54}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":54},{"groupId":"EG001","numAffected":3,"numAtRisk":54}]},{"term":"Abdominal Pain","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":54},{"groupId":"EG001","numAffected":3,"numAtRisk":54}]},{"term":"Elevated Blood Pressure","organSystem":"Vascular disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":54},{"groupId":"EG001","numAffected":3,"numAtRisk":54}]},{"term":"Decreased Appetite or changes in food cravings/tolerance","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":54},{"groupId":"EG001","numAffected":5,"numAtRisk":54}]},{"term":"GERD","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":54},{"groupId":"EG001","numAffected":7,"numAtRisk":54}]},{"term":"Elevated Creatine Kinase","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":54},{"groupId":"EG001","numAffected":4,"numAtRisk":54}]},{"term":"Sweating","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":54},{"groupId":"EG001","numAffected":6,"numAtRisk":54}]},{"term":"Dizziness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":54},{"groupId":"EG001","numAffected":4,"numAtRisk":54}]},{"term":"Elevated Low-density Lipoprotein","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":54},{"groupId":"EG001","numAffected":18,"numAtRisk":54}]},{"term":"Elevated Total Cholesterol","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":54},{"groupId":"EG001","numAffected":25,"numAtRisk":54}]},{"term":"Elevated Triglycerides","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":54},{"groupId":"EG001","numAffected":39,"numAtRisk":54}]},{"term":"Shakiness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":54},{"groupId":"EG001","numAffected":3,"numAtRisk":54}]},{"term":"Hunger","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":54},{"groupId":"EG001","numAffected":10,"numAtRisk":54}]},{"term":"Dysgeusia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":54},{"groupId":"EG001","numAffected":3,"numAtRisk":54}]},{"term":"Dry Mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":54},{"groupId":"EG001","numAffected":3,"numAtRisk":54}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Notably, participants were treated with 1.0 mg semaglutide weekly, the US Food and Drug Administration-approved dose at the time of study initiation. 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