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): 630
• 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
      • PMG Research of Wilmington, LLC
  • 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	Time Frame
Percent change from baseline in body weight	Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32

Secondary Outcome Measures

Outcome Measure	Time Frame
Body weight loss of greater than or equal to 5%	Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Percent change from baseline in body weight	Cohorts 1 and 2: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18 and 22; Cohort 3: Baseline, Week 4, 8, 12, 16, 20, 24 and 28
Absolute change from baseline in waist circumference	Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Absolute change from baseline in waist-to-hip ratio	Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Absolute change from baseline in hemoglobin A1c	Cohorts 1 and 2: Baseline, Week 16 and 26; Cohort 3: Baseline, Week 16, 24 and 32
Absolute change from baseline in fasting plasma glucose	Cohorts 1 and 2: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18, 22 and 26; Cohort 3: Baseline, Week 4, 8, 12, 16, 20, 24, 28 and 32
Incidence of treatment emergent adverse events (AEs and SAEs)	Cohorts 1 and 2: Baseline up to Week 31; Cohort 3: Baseline up to Week 37
Incidence of treatment emergent clinically significant laboratory abnormalities	Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34
Incidence of treatment emergent clinically significant vital sign abnormalities	Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34
Incidence of treatment emergent clinically significant electrocardiogram (ECG) abnormalities	Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34
Number of participants with categorical scores on the Columbia-Suicide Severity Rating Scale (C-SSRS)	Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34
Number of participants with categorical scores on the Patient Health Questionniare-9 (PHQ-9)	Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34

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 (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Weight loss
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; 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