A Study to Learn About the Study Medicine Called PF-07976016 in Adults With Obesity

Phase 2

Recruiting

• Conditions: Obesity
• Interventions: Drug: PF-07976016; Drug: Placebo

• Registration Number: NCT06717425
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07976016) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-07976016) to those of participants who take placebo (a lookalike 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 and how well they tolerate the study medicine.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Study Start: 2024-12-09
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-12-13
• Study Completion: 2026-01-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• Male or non-pregnant, non-breastfeeding female, 18 to 74 years of age at Visit 1
• Body Mass Index ≥30.0 kg/m2 at Visit 1, with stable body weight, defined as <5 kg change in the 12 weeks before Visit 1
• Eligible and willing to receive required background medicine
• Willing and able to comply with all study procedures

Key

Exclusion Criteria

• Any medical or psychiatric condition or laboratory abnormality, or recent serious illness or hospitalization, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study including diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes.
• Use of any prohibited prior or concomitant medication(s)
• Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests at Visit 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-07976016 Dose 1	PF-07976016	-
PF-07976016 Dose 2	PF-07976016	-
PF-07976016 Dose 3	PF-07976016	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in body weight	Baseline to Week 16

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events	From first dose (Day 1) up to 28-35 days after final dose, a total of approximately 21 weeks

Trial Locations

Locations (20)

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Westside Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

New Horizon Research Center; 🇺🇸 Miami, Florida, United States

St Johns Center for Clinical Research; 🇺🇸 Saint Augustine, Florida, United States

Rophe Adult and Pediatric Medicine/SKYCRNG; 🇺🇸 Union City, Georgia, United States

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States

L-MARC Research Center; 🇺🇸 Louisville, Kentucky, United States

Rochester Clinical Research, LLC; 🇺🇸 Rochester, New York, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Norman, Oklahoma, United States

Cornerstone Nutrition and Diabetes; 🇺🇸 Norman, Oklahoma, United States

Capital Area Research, LLC; 🇺🇸 Camp Hill, Pennsylvania, United States

Elligo Clinical Research Center; 🇺🇸 Austin, Texas, United States

Texas Diabetes & Endocrinology, P.A.; 🇺🇸 Austin, Texas, United States

Velocity Clinical Research, Dallas; 🇺🇸 Dallas, Texas, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Consano Clinical Research, LLC; 🇺🇸 Shavano Park, Texas, United States

Chrysalis Clinical Research; 🇺🇸 Saint George, Utah, United States

Southwest Internal Medicine, PC; 🇺🇸 Saint George, Utah, United States

Milestone Research Inc.; 🇨🇦 London, Ontario, Canada

Canadian Phase Onward; 🇨🇦 Toronto, Ontario, Canada