{"protocolSection":{"identificationModule":{"nctId":"NCT04707313","orgStudyIdInfo":{"id":"C3421019"},"secondaryIdInfos":[{"id":"2020-001312-19","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity","officialTitle":"A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY"},"statusModule":{"statusVerifiedDate":"2024-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-01-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-09-13","type":"ACTUAL"},"completionDateStruct":{"date":"2023-10-11","type":"ACTUAL"},"studyFirstSubmitDate":"2021-01-11","studyFirstSubmitQcDate":"2021-01-11","studyFirstPostDateStruct":{"date":"2021-01-13","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-09-12","resultsFirstSubmitQcDate":"2024-09-12","resultsFirstPostDateStruct":{"date":"2024-10-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-10-11","lastUpdatePostDateStruct":{"date":"2024-11-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight, waist and hip measurements, how well they tolerate the study medicine, and to measure levels of the study medicine in participants' blood.\n\nThis study is seeking participants who have obesity, who do not have diabetes and who have had a stable body weight and not participated in a formal weight loss program in the 90 days before the study. The study medicine or placebo will be taken as tablets by mouth 2 times a day (1 time in the morning and 1 time in the evening).\n\nThere are 3 groups of participants (called cohorts) in this study. For participants in Cohorts 1 and 2, total study participation will be about 9 months, with 15 planned study visits (14 visits to the study clinic and 1 telephone call). For participants in Cohort 3, total study participation will be about 10 months, with 21 planned study visits (12 visits to the study clinic and 9 telephone calls)."},"conditionsModule":{"conditions":["Obesity"],"keywords":["Weight loss"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":628,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo (Cohorts 1 and 2)","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo (Cohorts 1 and 2)"]},{"label":"PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1)","type":"EXPERIMENTAL","description":"The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID.","interventionNames":["Drug: PF-06882961 (Cohorts 1 and 2)"]},{"label":"PF-06882961 80 mg BID, 1-week titration (Cohort 1)","type":"EXPERIMENTAL","description":"The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID.","interventionNames":["Drug: PF-06882961 (Cohorts 1 and 2)"]},{"label":"PF-06882961 120 mg BID, 1-week titration (Cohort 1)","type":"EXPERIMENTAL","description":"The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID.","interventionNames":["Drug: PF-06882961 (Cohorts 1 and 2)"]},{"label":"PF-06882961 160 mg BID, 1-week titration (Cohort 1)","type":"EXPERIMENTAL","description":"The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID.","interventionNames":["Drug: PF-06882961 (Cohorts 1 and 2)"]},{"label":"PF-06882961 200 mg BID, 1-week titration (Cohort 1)","type":"EXPERIMENTAL","description":"The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID.","interventionNames":["Drug: PF-06882961 (Cohorts 1 and 2)"]},{"label":"PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2)","type":"EXPERIMENTAL","description":"The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID.","interventionNames":["Drug: PF-06882961 (Cohorts 1 and 2)"]},{"label":"PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2)","type":"EXPERIMENTAL","description":"The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID.","interventionNames":["Drug: PF-06882961 (Cohorts 1 and 2)"]},{"label":"PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2)","type":"EXPERIMENTAL","description":"The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID.","interventionNames":["Drug: PF-06882961 (Cohorts 1 and 2)"]},{"label":"Placebo (Cohort 3)","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo (Cohort 3)"]},{"label":"PF-06882961 80 mg BID, 4-week titration (Cohort 3)","type":"EXPERIMENTAL","description":"The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 80 mg BID.","interventionNames":["Drug: PF-06882961 (Cohort 3)"]},{"label":"PF-06882961 140 mg BID, 4-week titration (Cohort 3)","type":"EXPERIMENTAL","description":"The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 140 mg BID.","interventionNames":["Drug: PF-06882961 (Cohort 3)"]},{"label":"PF-06882961 200 mg BID, 4-week titration (Cohort 3)","type":"EXPERIMENTAL","description":"The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID.","interventionNames":["Drug: PF-06882961 (Cohort 3)"]}],"interventions":[{"type":"DRUG","name":"Placebo (Cohorts 1 and 2)","description":"4 matching placebo tablets taken twice daily","armGroupLabels":["Placebo (Cohorts 1 and 2)"]},{"type":"DRUG","name":"PF-06882961 (Cohorts 1 and 2)","description":"Participants will be randomized to one of 5 active target dose levels (40, 80, 120, 160 or 200 mg BID) achieved through 1-week titration steps, or 3 active target dose levels (120, 160 or 200 mg BID) achieved through 2-week titration steps, taking 4 tablets twice daily","armGroupLabels":["PF-06882961 120 mg BID, 1-week titration (Cohort 1)","PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2)","PF-06882961 160 mg BID, 1-week titration (Cohort 1)","PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2)","PF-06882961 200 mg BID, 1-week titration (Cohort 1)","PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2)","PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1)","PF-06882961 80 mg BID, 1-week titration (Cohort 1)"]},{"type":"DRUG","name":"Placebo (Cohort 3)","description":"2 matching placebo tablets taken twice daily","armGroupLabels":["Placebo (Cohort 3)"]},{"type":"DRUG","name":"PF-06882961 (Cohort 3)","description":"Participants will be randomized to one of 3 active target dose levels (80, 140 or 200 mg BID) achieved through 4-week titration steps, taking 2 tablets twice daily.","armGroupLabels":["PF-06882961 140 mg BID, 4-week titration (Cohort 3)","PF-06882961 200 mg BID, 4-week titration (Cohort 3)","PF-06882961 80 mg BID, 4-week titration (Cohort 3)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26","description":"Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100 multiply by \\[\\*\\](back-transformed LS Mean minus \\[-\\] 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Week 26"},{"measure":"Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32","description":"Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Week 32"}],"secondaryOutcomes":[{"measure":"Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)","description":"An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose met one or more of the criteria such as resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent disability or incapacity, congenital anomaly or birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. An adverse event is considered treatment-emergent relative to given treatment if the event starts during the effective duration of the treatment (i.e. starting on or after the first dose but before the last dose plus follow-up period).","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 31 weeks)"},{"measure":"Cohort 3: Number of Participants With TEAEs and TESAEs","description":"An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose met one or more of the criteria such as resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent disability or incapacity, congenital anomaly or birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. An adverse event is considered treatment-emergent relative to given treatment if the event starts during the effective duration of the treatment (i.e. starting on or after the first dose but before the last dose plus lag time).","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 37 weeks)"},{"measure":"Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality","description":"Laboratory parameters:a)hematology:hemoglobin(Hg),hematocrit,erythrocytes(ery),neutrophils,ery mean corpuscular volume,platelets,leukocytes(leu),lymphocytes,basophils,eosinophils,monocytes activated partial thromboplastin time, prothrombin time,prothrombin initial normalised ratio b)chemistry:direct bilirubin(bil),indirect bil, gamma glutamyl transferase,urea nitrogen,urate,sodium,potassium,calcium(cal),cal corrected,bicarbonate,Hg a1c,creatine kinase,bile acid,calcitonin,insulin-fasting,glucose fasting,amylase,lipase,thyrotropin,thyroxine,free,cholesterol,high density lipoprotein (hdl) cholesterol,triglycerides,alanine aminotransferase c)urinalysis:urine:pH,ketone,protein, Hg, urobilinogen,nitrite,leu esterase,ery,leu,tubular epithelial cells,squamous epithelial cells,granular casts,hyaline casts,uric acid crystals,calcium oxalate crystals,amorphous crystals,mucus,microscopic exam,spermatozoa,yeast budding,transitional epithelial cells,leu cell clumps;yeast hyphae.","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)"},{"measure":"Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality","description":"Laboratory parameters:a)hematology:hemoglobin(Hg),hematocrit,erythrocytes(ery),neutrophils,ery mean corpuscular volume,platelets,leukocytes(leu),lymphocytes,basophils,eosinophils,monocytes activated partial thromboplastin time, prothrombin time,prothrombin initial normalised ratio b)chemistry:direct bilirubin(bil),indirect bil, gamma glutamyl transferase,urea nitrogen,urate,sodium,potassium,calcium(cal),cal corrected,bicarbonate,Hg a1c,creatine kinase,bile acid,calcitonin,insulin-fasting,glucose fasting,amylase,lipase,thyrotropin,thyroxine,free,cholesterol,high density lipoprotein (hdl) cholesterol,triglycerides,alanine aminotransferase c)urinalysis:urine:pH,ketone,protein, Hg, urobilinogen,nitrite,leu esterase,ery,leu,tubular epithelial cells,squamous epithelial cells,granular casts,hyaline casts,uric acid crystals,calcium oxalate crystals,amorphous crystals,mucus,microscopic exam,spermatozoa,yeast budding,transitional epithelial cells,leu cell clumps;yeast hyphae.","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)"},{"measure":"Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data","description":"Vital signs of systolic blood pressure, diastolic blood pressure and pulse rate and were measured using an automated device with the participant in a supine position after five minutes of rest. This reports the number of participants that met the following pre-specified criteria: systolic blood pressure (SBP) \\<90 millimetres of mercury (mmHg), diastolic blood pressure (DBP) \\<50 mmHg, pulse rate (PR) \\<40 beats per minute, \\>120 beats per minute.","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)"},{"measure":"Cohort 3: Number of Participants According to Categorization of Vital Signs Data","description":"Vital signs of systolic blood pressure, diastolic blood pressure and pulse rate and were measured using an automated device with the participant in a supine position after five minutes of rest. This reports the number of participants that met the following pre-specified criteria: systolic blood pressure (SBP) \\<90 millimetres of mercury (mmHg), diastolic blood pressure (DBP) \\<50 mmHg, pulse rate (PR) \\<40 beats per minute, \\>120 beats per minute.","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)"},{"measure":"Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters","description":"Standard 12-lead ECGs were measured with the participant in a supine position after at least five minutes of rest. This reports the number of participants that met the following pre-specified criteria for ECG: QRS interval \\>=140; PR interval \\>=300; QTCF interval \\>500.","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)"},{"measure":"Cohort 3: Number of Participants According to Categorization of ECG Parameters","description":"Standard 12-lead ECGs were measured with the participant in a supine position after at least five minutes of rest. This reports the number of participants that met the following pre-specified criteria for ECG: QRS interval \\>=140; PR interval \\>=300; QTCF interval \\>500.","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)"},{"measure":"Cohorts 1 and 2: Number of Participants With Categorical Scores on Columbia-Suicide Severity Rating Scale (C-SSRS) Leading to Study Discontinuation","description":"C-SSRS is an interview-based rating scale to assess suicidal ideation and behavior. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.","timeFrame":"Week 0 (Baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)"},{"measure":"Cohort 3: Number of Participants With Categorical Scores on C-SSRS Leading to Study Discontinuation","description":"C-SSRS is an interview-based rating scale to assess suicidal ideation and behavior. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.","timeFrame":"Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)"},{"measure":"Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation","description":"PHQ-9 is a self-reported, nine-item scale for the assessment of depressive disorder. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.","timeFrame":"Week 0 (Baseline) , 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)"},{"measure":"Cohort 3: Number of Participants With Scores on the PHQ-9 Leading to Study Discontinuation","description":"PHQ-9 is a self-reported, nine-item scale for the assessment of depressive disorder. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.","timeFrame":"Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)"},{"measure":"Cohorts 1 and 2: Number of Participants With >= 5% Body Weight Loss at End of Treatment","description":"Number of participants with \\>= 5% body weight loss at end of treatment were reported.","timeFrame":"Week 26"},{"measure":"Cohort 3: Number of Participants With >=5% Body Weight Loss at End of Treatment","description":"Number of participants with \\>= 5% body weight loss at end of treatment were reported.","timeFrame":"Week 32"},{"measure":"Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22","description":"Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Weeks 2, 4, 6, 8, 10, 12,16, 18, 22"},{"measure":"Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28","description":"Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24 and 28"},{"measure":"Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26","description":"Absolute change from baseline in waist circumference were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Week 26"},{"measure":"Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32","description":"Absolute change from baseline in waist circumference were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Week 32"},{"measure":"Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26","description":"Absolute change from baseline in waist-to-hip ratio at end of treatment were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Week 26"},{"measure":"Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32","description":"Absolute change from baseline in waist-to-hip ratio at end of treatment were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Week 32"},{"measure":"Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26","description":"Absolute change from baseline in HbA1c were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Weeks 16 and 26"},{"measure":"Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32","description":"Absolute change from baseline in HbA1c were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Weeks 16, 24 and 32"},{"measure":"Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26","description":"Absolute change from baseline in FPG were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26"},{"measure":"Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32","description":"Absolute change from baseline in FPG were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2\n* Stable body weight, defined as \\<5 kg change (per participant report) for 90 days before visit 1\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption\n* Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes\n* History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1\n* Any malignancy not considered cured\n* Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC\n* History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any history of chronic pancreatitis\n* Symptomatic gallbladder disease\n* Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders\n* History of major depressive disorder or other severe psychiatric disorders within the last 2 years\n* Any lifetime history of a suicide attempt\n* Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis\n* Known history of HIV\n* Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)\n* Clinically relevant ECG abnormalities\n* Positive urine drug screen\n* Participation in a formal weight reduction program within 90 days prior to visit 1","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pinnacle Research Group, LLC","city":"Anniston","state":"Alabama","zip":"36207","country":"United States","geoPoint":{"lat":33.65983,"lon":-85.83163}},{"facility":"Anaheim Clinical Trials, LLC","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Velocity Clinical Research - 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Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study. Diabetes Obes Metab. 2025 Sep;27(9):4915-4926. doi: 10.1111/dom.16534. Epub 2025 Jun 20."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://pmiform.com/clinical-trial-info-request?StudyID=C3421019"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests.","url":"https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 1220 participants were screened (Cohorts 1 and 2: 926 and Cohort 3: 294), of which 592 failed screening and 628 were randomized (Cohorts 1 and 2: 499 and Cohort 3: 129) in the study. 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An SAE was defined as any untoward medical occurrence that, at any dose met one or more of the criteria such as resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent disability or incapacity, congenital anomaly or birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. An adverse event is considered treatment-emergent relative to given treatment if the event starts during the effective duration of the treatment (i.e. starting on or after the first dose but before the last dose plus follow-up period).","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 31 weeks)","groups":[{"id":"OG000","title":"Cohorts 1 and 2: Placebo","description":"Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks."},{"id":"OG001","title":"Cohort 1: PF-06882961 40mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks."},{"id":"OG002","title":"Cohort 1: PF-06882961 80mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks."},{"id":"OG003","title":"Cohort 1: PF-06882961 120mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG004","title":"Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG005","title":"Cohort 1: PF-06882961 160 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG006","title":"Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG007","title":"Cohort 1: PF-06882961 200 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."},{"id":"OG008","title":"Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"38"},{"groupId":"OG005","value":"63"},{"groupId":"OG006","value":"37"},{"groupId":"OG007","value":"63"},{"groupId":"OG008","value":"36"}]}],"classes":[{"title":"TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"59"},{"groupId":"OG003","value":"54"},{"groupId":"OG004","value":"32"},{"groupId":"OG005","value":"59"},{"groupId":"OG006","value":"30"},{"groupId":"OG007","value":"59"},{"groupId":"OG008","value":"30"}]}]},{"title":"TESAEs","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"1"}]}]}]},{"type":"SECONDARY","title":"Cohort 3: Number of Participants With TEAEs and TESAEs","description":"An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose met one or more of the criteria such as resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent disability or incapacity, congenital anomaly or birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. An adverse event is considered treatment-emergent relative to given treatment if the event starts during the effective duration of the treatment (i.e. starting on or after the first dose but before the last dose plus lag time).","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 37 weeks)","groups":[{"id":"OG000","title":"Cohort 3: Placebo","description":"Participants received placebo matched to PF-06882961 BID, orally for 32 weeks."},{"id":"OG001","title":"Cohort 3: PF-06882961 80mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks."},{"id":"OG002","title":"Cohort 3: PF-06882961 140mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks."},{"id":"OG003","title":"Cohort 3: PF-06882961 200mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"36"}]}],"classes":[{"title":"TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"34"}]}]},{"title":"TESAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"}]}]}]},{"type":"SECONDARY","title":"Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality","description":"Laboratory parameters:a)hematology:hemoglobin(Hg),hematocrit,erythrocytes(ery),neutrophils,ery mean corpuscular volume,platelets,leukocytes(leu),lymphocytes,basophils,eosinophils,monocytes activated partial thromboplastin time, prothrombin time,prothrombin initial normalised ratio b)chemistry:direct bilirubin(bil),indirect bil, gamma glutamyl transferase,urea nitrogen,urate,sodium,potassium,calcium(cal),cal corrected,bicarbonate,Hg a1c,creatine kinase,bile acid,calcitonin,insulin-fasting,glucose fasting,amylase,lipase,thyrotropin,thyroxine,free,cholesterol,high density lipoprotein (hdl) cholesterol,triglycerides,alanine aminotransferase c)urinalysis:urine:pH,ketone,protein, Hg, urobilinogen,nitrite,leu esterase,ery,leu,tubular epithelial cells,squamous epithelial cells,granular casts,hyaline casts,uric acid crystals,calcium oxalate crystals,amorphous crystals,mucus,microscopic exam,spermatozoa,yeast budding,transitional epithelial cells,leu cell clumps;yeast hyphae.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here \"Number of Participants Analyzed\" signifies participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)","groups":[{"id":"OG000","title":"Cohorts 1 and 2: Placebo","description":"Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks."},{"id":"OG001","title":"Cohort 1: PF-06882961 40mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks."},{"id":"OG002","title":"Cohort 1: PF-06882961 80mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks."},{"id":"OG003","title":"Cohort 1: PF-06882961 120mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG004","title":"Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG005","title":"Cohort 1: PF-06882961 160 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG006","title":"Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG007","title":"Cohort 1: PF-06882961 200 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."},{"id":"OG008","title":"Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"37"},{"groupId":"OG005","value":"62"},{"groupId":"OG006","value":"34"},{"groupId":"OG007","value":"63"},{"groupId":"OG008","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"60"},{"groupId":"OG003","value":"57"},{"groupId":"OG004","value":"37"},{"groupId":"OG005","value":"54"},{"groupId":"OG006","value":"33"},{"groupId":"OG007","value":"59"},{"groupId":"OG008","value":"33"}]}]}]},{"type":"SECONDARY","title":"Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality","description":"Laboratory parameters:a)hematology:hemoglobin(Hg),hematocrit,erythrocytes(ery),neutrophils,ery mean corpuscular volume,platelets,leukocytes(leu),lymphocytes,basophils,eosinophils,monocytes activated partial thromboplastin time, prothrombin time,prothrombin initial normalised ratio b)chemistry:direct bilirubin(bil),indirect bil, gamma glutamyl transferase,urea nitrogen,urate,sodium,potassium,calcium(cal),cal corrected,bicarbonate,Hg a1c,creatine kinase,bile acid,calcitonin,insulin-fasting,glucose fasting,amylase,lipase,thyrotropin,thyroxine,free,cholesterol,high density lipoprotein (hdl) cholesterol,triglycerides,alanine aminotransferase c)urinalysis:urine:pH,ketone,protein, Hg, urobilinogen,nitrite,leu esterase,ery,leu,tubular epithelial cells,squamous epithelial cells,granular casts,hyaline casts,uric acid crystals,calcium oxalate crystals,amorphous crystals,mucus,microscopic exam,spermatozoa,yeast budding,transitional epithelial cells,leu cell clumps;yeast hyphae.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here \"Number of Participants Analyzed\" signifies participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)","groups":[{"id":"OG000","title":"Cohort 3: Placebo","description":"Participants received placebo matched to PF-06882961 BID, orally for 32 weeks."},{"id":"OG001","title":"Cohort 3: PF-06882961 80mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks."},{"id":"OG002","title":"Cohort 3: PF-06882961 140mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks."},{"id":"OG003","title":"Cohort 3: PF-06882961 200mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"34"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"32"}]}]}]},{"type":"SECONDARY","title":"Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data","description":"Vital signs of systolic blood pressure, diastolic blood pressure and pulse rate and were measured using an automated device with the participant in a supine position after five minutes of rest. This reports the number of participants that met the following pre-specified criteria: systolic blood pressure (SBP) \\<90 millimetres of mercury (mmHg), diastolic blood pressure (DBP) \\<50 mmHg, pulse rate (PR) \\<40 beats per minute, \\>120 beats per minute.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here \"Overall Number of Participants Analyzed\" signifies participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)","groups":[{"id":"OG000","title":"Cohorts 1 and 2: Placebo","description":"Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks."},{"id":"OG001","title":"Cohort 1: PF-06882961 40mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks."},{"id":"OG002","title":"Cohort 1: PF-06882961 80mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks."},{"id":"OG003","title":"Cohort 1: PF-06882961 120mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG004","title":"Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG005","title":"Cohort 1: PF-06882961 160 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG006","title":"Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG007","title":"Cohort 1: PF-06882961 200 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."},{"id":"OG008","title":"Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"38"},{"groupId":"OG005","value":"63"},{"groupId":"OG006","value":"37"},{"groupId":"OG007","value":"63"},{"groupId":"OG008","value":"36"}]}],"classes":[{"title":"SBP Value < 90","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]},{"title":"DBP Value < 50","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]},{"title":"PR <40 beats per minute","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]},{"title":"PR >120 beats per minute","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]}]},{"type":"SECONDARY","title":"Cohort 3: Number of Participants According to Categorization of Vital Signs Data","description":"Vital signs of systolic blood pressure, diastolic blood pressure and pulse rate and were measured using an automated device with the participant in a supine position after five minutes of rest. This reports the number of participants that met the following pre-specified criteria: systolic blood pressure (SBP) \\<90 millimetres of mercury (mmHg), diastolic blood pressure (DBP) \\<50 mmHg, pulse rate (PR) \\<40 beats per minute, \\>120 beats per minute.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here \"Overall Number of Participants Analyzed\" signifies participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)","groups":[{"id":"OG000","title":"Cohort 3: Placebo","description":"Participants received placebo matched to PF-06882961 BID, orally for 32 weeks."},{"id":"OG001","title":"Cohort 3: PF-06882961 80mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks."},{"id":"OG002","title":"Cohort 3: PF-06882961 140mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks."},{"id":"OG003","title":"Cohort 3: PF-06882961 200mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"36"}]}],"classes":[{"title":"DBP Value < 50","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"SBP Value < 90","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"PR <40 beats per minute","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"PR >120 beats per minute","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters","description":"Standard 12-lead ECGs were measured with the participant in a supine position after at least five minutes of rest. This reports the number of participants that met the following pre-specified criteria for ECG: QRS interval \\>=140; PR interval \\>=300; QTCF interval \\>500.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. 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terms for treatment, strata \\[females versus males\\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.","paramType":"Odds Ratio (OR)","paramValue":"24.41","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.28","ciUpperLimit":"71.95"},{"groupIds":["OG000","OG008"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Logistic regression models (included terms for treatment, strata \\[females versus males\\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.","paramType":"Odds Ratio (OR)","paramValue":"12.65","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.56","ciUpperLimit":"35.08"}]},{"type":"SECONDARY","title":"Cohort 3: Number of Participants With 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Here, \"Number of Participants analyzed\" signifies number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 32","groups":[{"id":"OG000","title":"Cohort 3: Placebo","description":"Participants received placebo matched to PF-06882961 BID, orally for 32 weeks."},{"id":"OG001","title":"Cohort 3: PF-06882961 80mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks."},{"id":"OG002","title":"Cohort 3: PF-06882961 140mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks."},{"id":"OG003","title":"Cohort 3: PF-06882961 200mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Logistic regression models (included terms for treatment, strata \\[females versus males\\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.","paramType":"Odds Ratio (OR)","paramValue":"33.43","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.05","ciUpperLimit":"366.64"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Logistic regression models (included terms for treatment, strata \\[females versus males\\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.","paramType":"Odds Ratio (OR)","paramValue":"34.04","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.10","ciUpperLimit":"373.85"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Logistic regression models (included terms for treatment, strata \\[females versus males\\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.","paramType":"Odds Ratio (OR)","paramValue":"127.21","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"10.55","ciUpperLimit":"1533.46"}]},{"type":"SECONDARY","title":"Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22","description":"Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent Change","timeFrame":"Baseline, Weeks 2, 4, 6, 8, 10, 12,16, 18, 22","groups":[{"id":"OG000","title":"Cohorts 1 and 2: Placebo","description":"Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks."},{"id":"OG001","title":"Cohort 1: PF-06882961 40mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks."},{"id":"OG002","title":"Cohort 1: PF-06882961 80mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks."},{"id":"OG003","title":"Cohort 1: PF-06882961 120mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG004","title":"Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG005","title":"Cohort 1: PF-06882961 160 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG006","title":"Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG007","title":"Cohort 1: PF-06882961 200 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."},{"id":"OG008","title":"Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"38"},{"groupId":"OG005","value":"63"},{"groupId":"OG006","value":"37"},{"groupId":"OG007","value":"63"},{"groupId":"OG008","value":"36"}]}],"classes":[{"title":"Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"-0.13","spread":"0.001"},{"groupId":"OG001","value":"-0.85","spread":"0.001"},{"groupId":"OG002","value":"-0.54","spread":"0.001"},{"groupId":"OG003","value":"-0.98","spread":"0.001"},{"groupId":"OG004","value":"-0.58","spread":"0.002"},{"groupId":"OG005","value":"-0.87","spread":"0.001"},{"groupId":"OG006","value":"-0.22","spread":"0.002"},{"groupId":"OG007","value":"-0.96","spread":"0.001"},{"groupId":"OG008","value":"-0.53","spread":"0.002"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-0.15","spread":"0.002"},{"groupId":"OG001","value":"-1.65","spread":"0.002"},{"groupId":"OG002","value":"-1.69","spread":"0.002"},{"groupId":"OG003","value":"-1.99","spread":"0.002"},{"groupId":"OG004","value":"-1.26","spread":"0.003"},{"groupId":"OG005","value":"-1.71","spread":"0.002"},{"groupId":"OG006","value":"-0.93","spread":"0.003"},{"groupId":"OG007","value":"-1.98","spread":"0.002"},{"groupId":"OG008","value":"-1.28","spread":"0.003"}]}]},{"title":"Week 6","categories":[{"measurements":[{"groupId":"OG000","value":"-0.24","spread":"0.003"},{"groupId":"OG001","value":"-2.26","spread":"0.003"},{"groupId":"OG002","value":"-2.37","spread":"0.003"},{"groupId":"OG003","value":"-2.96","spread":"0.003"},{"groupId":"OG004","value":"-1.99","spread":"0.003"},{"groupId":"OG005","value":"-2.84","spread":"0.003"},{"groupId":"OG006","value":"-1.93","spread":"0.004"},{"groupId":"OG007","value":"-2.97","spread":"0.003"},{"groupId":"OG008","value":"-1.99","spread":"0.004"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"-0.41","spread":"0.003"},{"groupId":"OG001","value":"-2.93","spread":"0.003"},{"groupId":"OG002","value":"-2.86","spread":"0.003"},{"groupId":"OG003","value":"-3.89","spread":"0.003"},{"groupId":"OG004","value":"-3.33","spread":"0.004"},{"groupId":"OG005","value":"-3.87","spread":"0.004"},{"groupId":"OG006","value":"-2.34","spread":"0.004"},{"groupId":"OG007","value":"-3.83","spread":"0.004"},{"groupId":"OG008","value":"-2.94","spread":"0.004"}]}]},{"title":"Week 10","categories":[{"measurements":[{"groupId":"OG000","value":"-0.50","spread":"0.004"},{"groupId":"OG001","value":"-3.47","spread":"0.004"},{"groupId":"OG002","value":"-3.33","spread":"0.004"},{"groupId":"OG003","value":"-4.82","spread":"0.004"},{"groupId":"OG004","value":"-3.92","spread":"0.005"},{"groupId":"OG005","value":"-4.67","spread":"0.004"},{"groupId":"OG006","value":"-3.20","spread":"0.005"},{"groupId":"OG007","value":"-4.54","spread":"0.004"},{"groupId":"OG008","value":"-3.83","spread":"0.005"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-0.44","spread":"0.004"},{"groupId":"OG001","value":"-3.89","spread":"0.005"},{"groupId":"OG002","value":"-3.88","spread":"0.004"},{"groupId":"OG003","value":"-5.31","spread":"0.005"},{"groupId":"OG004","value":"-4.49","spread":"0.006"},{"groupId":"OG005","value":"-5.66","spread":"0.005"},{"groupId":"OG006","value":"-3.98","spread":"0.006"},{"groupId":"OG007","value":"-5.33","spread":"0.005"},{"groupId":"OG008","value":"-4.34","spread":"0.006"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-0.40","spread":"0.005"},{"groupId":"OG001","value":"-4.73","spread":"0.006"},{"groupId":"OG002","value":"-4.01","spread":"0.006"},{"groupId":"OG003","value":"-6.98","spread":"0.006"},{"groupId":"OG004","value":"-5.49","spread":"0.008"},{"groupId":"OG005","value":"-7.04","spread":"0.007"},{"groupId":"OG006","value":"-5.15","spread":"0.008"},{"groupId":"OG007","value":"-6.56","spread":"0.007"},{"groupId":"OG008","value":"-5.18","spread":"0.008"}]}]},{"title":"Week 18","categories":[{"measurements":[{"groupId":"OG000","value":"-0.50","spread":"0.006"},{"groupId":"OG001","value":"-4.94","spread":"0.006"},{"groupId":"OG002","value":"-4.68","spread":"0.006"},{"groupId":"OG003","value":"-7.33","spread":"0.007"},{"groupId":"OG004","value":"-6.33","spread":"0.008"},{"groupId":"OG005","value":"-7.50","spread":"0.007"},{"groupId":"OG006","value":"-5.57","spread":"0.009"},{"groupId":"OG007","value":"-7.27","spread":"0.007"},{"groupId":"OG008","value":"-5.80","spread":"0.008"}]}]},{"title":"Week 22","categories":[{"measurements":[{"groupId":"OG000","value":"-0.18","spread":"0.007"},{"groupId":"OG001","value":"-5.06","spread":"0.008"},{"groupId":"OG002","value":"-5.00","spread":"0.007"},{"groupId":"OG003","value":"-8.10","spread":"0.008"},{"groupId":"OG004","value":"-6.43","spread":"0.010"},{"groupId":"OG005","value":"-8.63","spread":"0.009"},{"groupId":"OG006","value":"-6.57","spread":"0.011"},{"groupId":"OG007","value":"-8.23","spread":"0.009"},{"groupId":"OG008","value":"-6.60","spread":"0.010"}]}]}]},{"type":"SECONDARY","title":"Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28","description":"Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent Change","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24 and 28","groups":[{"id":"OG000","title":"Cohort 3: Placebo","description":"Participants received placebo matched to PF-06882961 BID, orally for 32 weeks."},{"id":"OG001","title":"Cohort 3: PF-06882961 80mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks."},{"id":"OG002","title":"Cohort 3: PF-06882961 140mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks."},{"id":"OG003","title":"Cohort 3: PF-06882961 200mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"36"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-0.37","spread":"0.004"},{"groupId":"OG001","value":"-1.38","spread":"0.003"},{"groupId":"OG002","value":"-0.95","spread":"0.003"},{"groupId":"OG003","value":"-1.02","spread":"0.003"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"-0.06","spread":"0.006"},{"groupId":"OG001","value":"-2.07","spread":"0.004"},{"groupId":"OG002","value":"-1.93","spread":"0.004"},{"groupId":"OG003","value":"-1.89","spread":"0.004"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-0.08","spread":"0.008"},{"groupId":"OG001","value":"-2.80","spread":"0.006"},{"groupId":"OG002","value":"-2.88","spread":"0.005"},{"groupId":"OG003","value":"-2.96","spread":"0.006"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"0.03","spread":"0.011"},{"groupId":"OG001","value":"-4.13","spread":"0.008"},{"groupId":"OG002","value":"-3.99","spread":"0.007"},{"groupId":"OG003","value":"-4.73","spread":"0.008"}]}]},{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"0.38","spread":"0.014"},{"groupId":"OG001","value":"-5.17","spread":"0.010"},{"groupId":"OG002","value":"-5.25","spread":"0.009"},{"groupId":"OG003","value":"-7.10","spread":"0.010"}]}]},{"title":"Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"0.36","spread":"0.015"},{"groupId":"OG001","value":"-5.65","spread":"0.011"},{"groupId":"OG002","value":"-6.39","spread":"0.011"},{"groupId":"OG003","value":"-9.20","spread":"0.011"}]}]},{"title":"Week 28","categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"0.017"},{"groupId":"OG001","value":"-6.37","spread":"0.013"},{"groupId":"OG002","value":"-6.74","spread":"0.012"},{"groupId":"OG003","value":"-10.44","spread":"0.013"}]}]}]},{"type":"SECONDARY","title":"Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26","description":"Absolute change from baseline in waist circumference were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Centimeter","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Cohorts 1 and 2: Placebo","description":"Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks."},{"id":"OG001","title":"Cohort 1: PF-06882961 40mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks."},{"id":"OG002","title":"Cohort 1: PF-06882961 80mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks."},{"id":"OG003","title":"Cohort 1: PF-06882961 120mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG004","title":"Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG005","title":"Cohort 1: PF-06882961 160 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG006","title":"Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG007","title":"Cohort 1: PF-06882961 200 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."},{"id":"OG008","title":"Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"38"},{"groupId":"OG005","value":"63"},{"groupId":"OG006","value":"37"},{"groupId":"OG007","value":"63"},{"groupId":"OG008","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.25","spread":"0.826"},{"groupId":"OG001","value":"-6.49","spread":"0.995"},{"groupId":"OG002","value":"-5.75","spread":"0.943"},{"groupId":"OG003","value":"-6.19","spread":"1.023"},{"groupId":"OG004","value":"-5.98","spread":"1.338"},{"groupId":"OG005","value":"-9.05","spread":"1.174"},{"groupId":"OG006","value":"-7.41","spread":"1.490"},{"groupId":"OG007","value":"-7.56","spread":"1.281"},{"groupId":"OG008","value":"-6.36","spread":"1.350"}]}]}]},{"type":"SECONDARY","title":"Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32","description":"Absolute change from baseline in waist circumference were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Centimeter","timeFrame":"Baseline, Week 32","groups":[{"id":"OG000","title":"Cohort 3: Placebo","description":"Participants received placebo matched to PF-06882961 BID, orally for 32 weeks."},{"id":"OG001","title":"Cohort 3: PF-06882961 80mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks."},{"id":"OG002","title":"Cohort 3: PF-06882961 140mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks."},{"id":"OG003","title":"Cohort 3: PF-06882961 200mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.19","spread":"1.967"},{"groupId":"OG001","value":"-6.27","spread":"1.628"},{"groupId":"OG002","value":"-7.77","spread":"1.564"},{"groupId":"OG003","value":"-11.43","spread":"1.698"}]}]}]},{"type":"SECONDARY","title":"Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26","description":"Absolute change from baseline in waist-to-hip ratio at end of treatment were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention in Part A and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Ratio","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Cohorts 1 and 2: Placebo","description":"Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks."},{"id":"OG001","title":"Cohort 1: PF-06882961 40mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks."},{"id":"OG002","title":"Cohort 1: PF-06882961 80mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks."},{"id":"OG003","title":"Cohort 1: PF-06882961 120mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG004","title":"Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG005","title":"Cohort 1: PF-06882961 160 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG006","title":"Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG007","title":"Cohort 1: PF-06882961 200 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."},{"id":"OG008","title":"Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"38"},{"groupId":"OG005","value":"63"},{"groupId":"OG006","value":"37"},{"groupId":"OG007","value":"63"},{"groupId":"OG008","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.002","spread":"0.0064"},{"groupId":"OG001","value":"-0.002","spread":"0.0076"},{"groupId":"OG002","value":"-0.015","spread":"0.0073"},{"groupId":"OG003","value":"0.001","spread":"0.0078"},{"groupId":"OG004","value":"-0.014","spread":"0.0104"},{"groupId":"OG005","value":"-0.015","spread":"0.0090"},{"groupId":"OG006","value":"-0.014","spread":"0.0114"},{"groupId":"OG007","value":"-0.007","spread":"0.0098"},{"groupId":"OG008","value":"0.004","spread":"0.0104"}]}]}]},{"type":"SECONDARY","title":"Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32","description":"Absolute change from baseline in waist-to-hip ratio at end of treatment were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Ratio","timeFrame":"Baseline, Week 32","groups":[{"id":"OG000","title":"Cohort 3: Placebo","description":"Participants received placebo matched to PF-06882961 BID, orally for 32 weeks."},{"id":"OG001","title":"Cohort 3: PF-06882961 80mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks."},{"id":"OG002","title":"Cohort 3: PF-06882961 140mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks."},{"id":"OG003","title":"Cohort 3: PF-06882961 200mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.010","spread":"0.0128"},{"groupId":"OG001","value":"-0.012","spread":"0.0113"},{"groupId":"OG002","value":"-0.009","spread":"0.0108"},{"groupId":"OG003","value":"-0.016","spread":"0.0121"}]}]}]},{"type":"SECONDARY","title":"Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26","description":"Absolute change from baseline in HbA1c were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, Weeks 16 and 26","groups":[{"id":"OG000","title":"Cohorts 1 and 2: Placebo","description":"Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks."},{"id":"OG001","title":"Cohort 1: PF-06882961 40mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks."},{"id":"OG002","title":"Cohort 1: PF-06882961 80mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks."},{"id":"OG003","title":"Cohort 1: PF-06882961 120mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG004","title":"Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG005","title":"Cohort 1: PF-06882961 160 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG006","title":"Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG007","title":"Cohort 1: PF-06882961 200 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."},{"id":"OG008","title":"Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"38"},{"groupId":"OG005","value":"63"},{"groupId":"OG006","value":"37"},{"groupId":"OG007","value":"63"},{"groupId":"OG008","value":"36"}]}],"classes":[{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.034"},{"groupId":"OG001","value":"-0.24","spread":"0.039"},{"groupId":"OG002","value":"-0.24","spread":"0.039"},{"groupId":"OG003","value":"-0.26","spread":"0.042"},{"groupId":"OG004","value":"-0.25","spread":"0.056"},{"groupId":"OG005","value":"-0.29","spread":"0.050"},{"groupId":"OG006","value":"-0.18","spread":"0.061"},{"groupId":"OG007","value":"-0.23","spread":"0.053"},{"groupId":"OG008","value":"-0.24","spread":"0.054"}]}]},{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.036"},{"groupId":"OG001","value":"-0.17","spread":"0.045"},{"groupId":"OG002","value":"-0.13","spread":"0.044"},{"groupId":"OG003","value":"-0.22","spread":"0.046"},{"groupId":"OG004","value":"-0.16","spread":"0.064"},{"groupId":"OG005","value":"-0.31","spread":"0.055"},{"groupId":"OG006","value":"-0.13","spread":"0.070"},{"groupId":"OG007","value":"-0.17","spread":"0.062"},{"groupId":"OG008","value":"-0.26","spread":"0.064"}]}]}]},{"type":"SECONDARY","title":"Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32","description":"Absolute change from baseline in HbA1c were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, Weeks 16, 24 and 32","groups":[{"id":"OG000","title":"Cohort 3: Placebo","description":"Participants received placebo matched to PF-06882961 BID, orally for 32 weeks."},{"id":"OG001","title":"Cohort 3: PF-06882961 80mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks."},{"id":"OG002","title":"Cohort 3: PF-06882961 140mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks."},{"id":"OG003","title":"Cohort 3: PF-06882961 200mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"36"}]}],"classes":[{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"0.061"},{"groupId":"OG001","value":"-0.16","spread":"0.048"},{"groupId":"OG002","value":"-0.26","spread":"0.044"},{"groupId":"OG003","value":"-0.29","spread":"0.042"}]}]},{"title":"Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"0.05","spread":"0.070"},{"groupId":"OG001","value":"-0.13","spread":"0.059"},{"groupId":"OG002","value":"-0.21","spread":"0.055"},{"groupId":"OG003","value":"-0.31","spread":"0.059"}]}]},{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","spread":"0.074"},{"groupId":"OG001","value":"-0.11","spread":"0.064"},{"groupId":"OG002","value":"-0.27","spread":"0.059"},{"groupId":"OG003","value":"-0.41","spread":"0.068"}]}]}]},{"type":"SECONDARY","title":"Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26","description":"Absolute change from baseline in FPG were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Milligram per deciliter","timeFrame":"Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26","groups":[{"id":"OG000","title":"Cohorts 1 and 2: Placebo","description":"Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks."},{"id":"OG001","title":"Cohort 1: PF-06882961 40mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks."},{"id":"OG002","title":"Cohort 1: PF-06882961 80mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks."},{"id":"OG003","title":"Cohort 1: PF-06882961 120mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG004","title":"Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks."},{"id":"OG005","title":"Cohort 1: PF-06882961 160 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG006","title":"Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks."},{"id":"OG007","title":"Cohort 1: PF-06882961 200 mg BID (1-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."},{"id":"OG008","title":"Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"38"},{"groupId":"OG005","value":"63"},{"groupId":"OG006","value":"37"},{"groupId":"OG007","value":"63"},{"groupId":"OG008","value":"36"}]}],"classes":[{"title":"Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"3.22","spread":"0.903"},{"groupId":"OG001","value":"-2.93","spread":"0.963"},{"groupId":"OG002","value":"-2.56","spread":"0.939"},{"groupId":"OG003","value":"-4.02","spread":"0.940"},{"groupId":"OG004","value":"-2.02","spread":"1.245"},{"groupId":"OG005","value":"-4.51","spread":"0.957"},{"groupId":"OG006","value":"-1.16","spread":"1.265"},{"groupId":"OG007","value":"-2.82","spread":"0.939"},{"groupId":"OG008","value":"-2.93","spread":"1.250"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"3.38","spread":"1.082"},{"groupId":"OG001","value":"-2.75","spread":"1.196"},{"groupId":"OG002","value":"-2.97","spread":"1.166"},{"groupId":"OG003","value":"-3.59","spread":"1.155"},{"groupId":"OG004","value":"-0.83","spread":"1.443"},{"groupId":"OG005","value":"-4.81","spread":"1.199"},{"groupId":"OG006","value":"-2.56","spread":"1.504"},{"groupId":"OG007","value":"-6.24","spread":"1.164"},{"groupId":"OG008","value":"-3.86","spread":"1.485"}]}]},{"title":"Week 6","categories":[{"measurements":[{"groupId":"OG000","value":"1.45","spread":"0.936"},{"groupId":"OG001","value":"-4.28","spread":"1.021"},{"groupId":"OG002","value":"-2.29","spread":"1.035"},{"groupId":"OG003","value":"-6.38","spread":"1.044"},{"groupId":"OG004","value":"-4.17","spread":"1.290"},{"groupId":"OG005","value":"-3.46","spread":"1.102"},{"groupId":"OG006","value":"-3.06","spread":"1.371"},{"groupId":"OG007","value":"-4.32","spread":"1.095"},{"groupId":"OG008","value":"-4.64","spread":"1.311"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"1.61","spread":"0.956"},{"groupId":"OG001","value":"-3.72","spread":"1.068"},{"groupId":"OG002","value":"-3.15","spread":"1.103"},{"groupId":"OG003","value":"-2.56","spread":"1.130"},{"groupId":"OG004","value":"-2.77","spread":"1.385"},{"groupId":"OG005","value":"-4.48","spread":"1.177"},{"groupId":"OG006","value":"-4.07","spread":"1.438"},{"groupId":"OG007","value":"-4.90","spread":"1.248"},{"groupId":"OG008","value":"-2.82","spread":"1.367"}]}]},{"title":"Week 10","categories":[{"measurements":[{"groupId":"OG000","value":"2.47","spread":"1.146"},{"groupId":"OG001","value":"-2.52","spread":"1.264"},{"groupId":"OG002","value":"-1.79","spread":"1.251"},{"groupId":"OG003","value":"-4.74","spread":"1.353"},{"groupId":"OG004","value":"-2.60","spread":"1.662"},{"groupId":"OG005","value":"-4.17","spread":"1.498"},{"groupId":"OG006","value":"-5.26","spread":"1.702"},{"groupId":"OG007","value":"-5.35","spread":"1.525"},{"groupId":"OG008","value":"-2.85","spread":"1.558"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"2.57","spread":"1.229"},{"groupId":"OG001","value":"-2.70","spread":"1.408"},{"groupId":"OG002","value":"-0.77","spread":"1.377"},{"groupId":"OG003","value":"-2.24","spread":"1.492"},{"groupId":"OG004","value":"-1.22","spread":"1.889"},{"groupId":"OG005","value":"-4.86","spread":"1.686"},{"groupId":"OG006","value":"-4.65","spread":"1.908"},{"groupId":"OG007","value":"-3.01","spread":"1.716"},{"groupId":"OG008","value":"-3.19","spread":"1.764"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"0.50","spread":"1.352"},{"groupId":"OG001","value":"-2.67","spread":"1.523"},{"groupId":"OG002","value":"-2.04","spread":"1.537"},{"groupId":"OG003","value":"-2.56","spread":"1.619"},{"groupId":"OG004","value":"-6.99","spread":"2.143"},{"groupId":"OG005","value":"-6.62","spread":"1.926"},{"groupId":"OG006","value":"-5.73","spread":"2.338"},{"groupId":"OG007","value":"-4.67","spread":"2.011"},{"groupId":"OG008","value":"-5.24","spread":"2.097"}]}]},{"title":"Week 18","categories":[{"measurements":[{"groupId":"OG000","value":"4.34","spread":"1.407"},{"groupId":"OG001","value":"-0.44","spread":"1.634"},{"groupId":"OG002","value":"-3.73","spread":"1.593"},{"groupId":"OG003","value":"0.19","spread":"1.770"},{"groupId":"OG004","value":"-0.96","spread":"2.294"},{"groupId":"OG005","value":"-4.76","spread":"2.030"},{"groupId":"OG006","value":"-5.23","spread":"2.684"},{"groupId":"OG007","value":"0.11","spread":"2.175"},{"groupId":"OG008","value":"0.53","spread":"2.189"}]}]},{"title":"Week 22","categories":[{"measurements":[{"groupId":"OG000","value":"4.83","spread":"1.494"},{"groupId":"OG001","value":"0.38","spread":"1.872"},{"groupId":"OG002","value":"-3.22","spread":"1.712"},{"groupId":"OG003","value":"-4.27","spread":"1.842"},{"groupId":"OG004","value":"-1.78","spread":"2.502"},{"groupId":"OG005","value":"-2.03","spread":"2.205"},{"groupId":"OG006","value":"-1.65","spread":"2.888"},{"groupId":"OG007","value":"-4.64","spread":"2.460"},{"groupId":"OG008","value":"-5.08","spread":"2.580"}]}]},{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"3.34","spread":"1.220"},{"groupId":"OG001","value":"-3.37","spread":"1.499"},{"groupId":"OG002","value":"-3.43","spread":"1.469"},{"groupId":"OG003","value":"-4.02","spread":"1.555"},{"groupId":"OG004","value":"-3.75","spread":"2.059"},{"groupId":"OG005","value":"-6.00","spread":"1.804"},{"groupId":"OG006","value":"-3.50","spread":"2.290"},{"groupId":"OG007","value":"-6.60","spread":"2.010"},{"groupId":"OG008","value":"-5.01","spread":"2.172"}]}]}]},{"type":"SECONDARY","title":"Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32","description":"Absolute change from baseline in FPG were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.","populationDescription":"Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Milligram per deciliter","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Cohort 3: Placebo","description":"Participants received placebo matched to PF-06882961 BID, orally for 32 weeks."},{"id":"OG001","title":"Cohort 3: PF-06882961 80mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks."},{"id":"OG002","title":"Cohort 3: PF-06882961 140mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks."},{"id":"OG003","title":"Cohort 3: PF-06882961 200mg BID (4-week Titration)","description":"Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"36"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-1.82","spread":"2.327"},{"groupId":"OG001","value":"-0.83","spread":"1.652"},{"groupId":"OG002","value":"0.96","spread":"1.616"},{"groupId":"OG003","value":"3.84","spread":"1.671"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"0.10","spread":"2.523"},{"groupId":"OG001","value":"1.79","spread":"1.748"},{"groupId":"OG002","value":"-1.16","spread":"1.659"},{"groupId":"OG003","value":"2.52","spread":"1.720"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-1.28","spread":"2.588"},{"groupId":"OG001","value":"-1.80","spread":"1.883"},{"groupId":"OG002","value":"1.56","spread":"1.755"},{"groupId":"OG003","value":"-0.42","spread":"1.761"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-5.75","spread":"2.348"},{"groupId":"OG001","value":"-5.18","spread":"1.778"},{"groupId":"OG002","value":"-2.43","spread":"1.654"},{"groupId":"OG003","value":"0.88","spread":"1.618"}]}]},{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"1.52","spread":"2.175"},{"groupId":"OG001","value":"-1.95","spread":"1.774"},{"groupId":"OG002","value":"-4.78","spread":"1.687"},{"groupId":"OG003","value":"-1.39","spread":"1.628"}]}]},{"title":"Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"-2.80","spread":"2.664"},{"groupId":"OG001","value":"-0.13","spread":"2.088"},{"groupId":"OG002","value":"-2.00","spread":"2.014"},{"groupId":"OG003","value":"1.62","spread":"2.158"}]}]},{"title":"Week 28","categories":[{"measurements":[{"groupId":"OG000","value":"1.67","spread":"2.518"},{"groupId":"OG001","value":"-0.15","spread":"2.044"},{"groupId":"OG002","value":"-4.53","spread":"1.983"},{"groupId":"OG003","value":"0.90","spread":"2.221"}]}]},{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-1.81","spread":"3.006"},{"groupId":"OG001","value":"1.28","spread":"2.491"},{"groupId":"OG002","value":"-1.65","spread":"2.446"},{"groupId":"OG003","value":"-1.73","spread":"2.582"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)","description":"An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. 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