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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707313
• Other study ID #: C3421019
• Secondary ID: 2020-001312-19
• Status: Completed
• Phase: Phase 2
• Start date: January 29, 2021
• Est. completion date: October 11, 2023

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: October 11, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Placebo (Cohorts 1 and 2)
4 matching placebo tablets taken twice daily
• 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 (Cohort 3)
2 matching placebo tablets taken twice daily
• 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.

Locations

Country	Name	City	State
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	Ecogene-21	Chicoutimi	Quebec
Canada	Milestone Research , Inc	London	Ontario
Canada	Alpha Recherche Clinique	Quebec
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Diex Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Manna Research Toronto	Toronto	Ontario
Canada	Rivergrove Medical Clinic	Winnipeg	Manitoba
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Tokyo Center Clinic	Chuo-ku	Tokyo
Japan	Medical Corporation Heishinkai ToCROM Clinic	Shinjuku-ku	Tokyo
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Taiwan	China Medical University Hospital	Taichung City
Taiwan	National Cheng Kung University Hospital	Tainan
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Internal Medicine and Pediatric Associates of Bristol, PC	Bristol	Tennessee
United States	Velocity Clinical Research, Inc.	Cleveland	Ohio
United States	Alliance for Multispecialty Research, LLC	Coral Gables	Florida
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Clinical Investigation Specialists	Gurnee	Illinois
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	PMG Research, Inc. d/b/a PMG Research of Knoxville	Knoxville	Tennessee
United States	Velocity Clinical Research - Westlake	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	ActivMed Practices & Research, LLC	Methuen	Massachusetts
United States	Optimus U Corporation	Miami	Florida
United States	Clinical Trials of South Carolina	Moncks Corner	South Carolina
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Velocity Clinical Research, Omaha	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	PMG Research of Salisbury, LLC	Salisbury	North Carolina
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Palmetto Primary Care Physicians (Sub-I physicals only)	Summerville	South Carolina
United States	ForCare Clinical Research	Tampa	Florida
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Velocity Clinical Research, Valparaiso	Valparaiso	Indiana
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Japan,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in body weight		Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Secondary	Body weight loss of greater than or equal to 5%		Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Secondary	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
Secondary	Absolute change from baseline in waist circumference		Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Secondary	Absolute change from baseline in waist-to-hip ratio		Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Secondary	Absolute change from baseline in hemoglobin A1c		Cohorts 1 and 2: Baseline, Week 16 and 26; Cohort 3: Baseline, Week 16, 24 and 32
Secondary	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
Secondary	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
Secondary	Incidence of treatment emergent clinically significant laboratory abnormalities		Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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