A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

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

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.

This 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).

There 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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo (Cohorts 1 and 2); Drug: PF-06882961 (Cohorts 1 and 2); Drug: Placebo (Cohort 3); Drug: PF-06882961 (Cohort 3)

• Study Type: Interventional
• Enrollment (Actual): 628
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G2J 0C4
    • ALPHA Recherche Clinique
  • Quebec, Canada, G1W4R4
    • Centre de Recherche Saint-Louis
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 4W3
      • Rivergrove Medical Clinic
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research , Inc
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research Toronto
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Ecogene-21
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • DIEX Recherche Sherbrooke Inc.
• Japan
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 103-0028
      • Tokyo Center Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Shinjuku-ku, Tokyo, Japan, 160-0008
      • Medical Corporation Heishinkai ToCROM Clinic
• Taiwan
  • Taichung City, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research - Westlake
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Alliance for Multispecialty Research, LLC
    • Miami, Florida, United States, 33125
      • Optimus U Corporation
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists
  • Indiana
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clinical Research, Valparaiso
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • PMG Research of Hickory, LLC
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury, LLC
    • Wilmington, North Carolina, United States, 28401
      • Accellacare - Wilmington
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research LLC
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research, Inc.
  • South Carolina
    • Moncks Corner, South Carolina, United States, 29461
      • Clinical Trials of South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
    • Summerville, South Carolina, United States, 29485
      • Palmetto Primary Care Physicians (Sub-I physicals only)
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Internal Medicine and Pediatric Associates of Bristol, PC
    • Knoxville, Tennessee, United States, 37938
      • PMG Research, Inc. d/b/a PMG Research of Knoxville
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2
• Stable body weight, defined as <5 kg change (per participant report) for 90 days before visit 1

Exclusion Criteria:

• Any condition possibly affecting drug absorption
• Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes
• History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1
• Any malignancy not considered cured
• Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC
• History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any history of chronic pancreatitis
• Symptomatic gallbladder disease
• Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders
• History of major depressive disorder or other severe psychiatric disorders within the last 2 years
• Any lifetime history of a suicide attempt
• Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
• Known history of HIV
• Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
• Clinically relevant ECG abnormalities
• Positive urine drug screen
• Participation in a formal weight reduction program within 90 days prior to visit 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (Cohorts 1 and 2)	Drug: Placebo (Cohorts 1 and 2); 4 matching placebo tablets taken twice daily
Experimental: PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1); The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID.	Drug: PF-06882961 (Cohorts 1 and 2); 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
Experimental: PF-06882961 80 mg BID, 1-week titration (Cohort 1); The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID.	Drug: PF-06882961 (Cohorts 1 and 2); 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
Experimental: PF-06882961 120 mg BID, 1-week titration (Cohort 1); The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID.	Drug: PF-06882961 (Cohorts 1 and 2); 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
Experimental: PF-06882961 160 mg BID, 1-week titration (Cohort 1); The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID.	Drug: PF-06882961 (Cohorts 1 and 2); 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
Experimental: PF-06882961 200 mg BID, 1-week titration (Cohort 1); The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID.	Drug: PF-06882961 (Cohorts 1 and 2); 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
Experimental: PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2); The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID.	Drug: PF-06882961 (Cohorts 1 and 2); 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
Experimental: PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2); The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID.	Drug: PF-06882961 (Cohorts 1 and 2); 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
Experimental: PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2); The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID.	Drug: PF-06882961 (Cohorts 1 and 2); 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
Placebo Comparator: Placebo (Cohort 3)	Drug: Placebo (Cohort 3); 2 matching placebo tablets taken twice daily
Experimental: PF-06882961 80 mg BID, 4-week titration (Cohort 3); The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 80 mg BID.	Drug: PF-06882961 (Cohort 3); 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.
Experimental: PF-06882961 140 mg BID, 4-week titration (Cohort 3); The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 140 mg BID.	Drug: PF-06882961 (Cohort 3); 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.
Experimental: PF-06882961 200 mg BID, 4-week titration (Cohort 3); The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID.	Drug: PF-06882961 (Cohort 3); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26	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.	Baseline, Week 26
Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32	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.	Baseline, Week 32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)	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).	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)
Cohort 3: Number of Participants With TEAEs and TESAEs	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).	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)
Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality	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.	From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality	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.	From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data	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.	From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants According to Categorization of Vital Signs Data	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.	From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters	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.	From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants According to Categorization of ECG Parameters	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.	From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants With Categorical Scores on Columbia-Suicide Severity Rating Scale (C-SSRS) Leading to Study Discontinuation	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.	Week 0 (Baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)
Cohort 3: Number of Participants With Categorical Scores on C-SSRS Leading to Study Discontinuation	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.	Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)
Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation	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.	Week 0 (Baseline) , 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)
Cohort 3: Number of Participants With Scores on the PHQ-9 Leading to Study Discontinuation	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.	Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)
Cohorts 1 and 2: Number of Participants With >= 5% Body Weight Loss at End of Treatment	Number of participants with >= 5% body weight loss at end of treatment were reported.	Week 26
Cohort 3: Number of Participants With >=5% Body Weight Loss at End of Treatment	Number of participants with >= 5% body weight loss at end of treatment were reported.	Week 32
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22	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.	Baseline, Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28	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.	Baseline, Weeks 4, 8, 12, 16, 20, 24 and 28
Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26	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.	Baseline, Week 26
Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32	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.	Baseline, Week 32
Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26	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.	Baseline, Week 26
Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32	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.	Baseline, Week 32
Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26	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.	Baseline, Weeks 16 and 26
Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32	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.	Baseline, Weeks 16, 24 and 32
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	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.	Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32	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.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): October 11, 2023

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Weight loss
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: C3421019; 2020-001312-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No