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

February 4, 2026 updated by: Pfizer

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY OF PF-07976016 TO ASSESS SAFETY AND EFFICACY IN ADULT PARTICIPANTS WITH OBESITY

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3Z 2N6
        • Ocean West Research Clinic
    • Ontario
      • Guelph, Ontario, Canada, N1H 1B1
        • Dawson Clinical Research Inc.
      • Hamilton, Ontario, Canada, L8L 5G8
        • The Wharton Medical Clinic Clinical Trials Inc.
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research Inc.
      • Toronto, Ontario, Canada, M3J 0K2
        • Canadian Phase Onward
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-589
        • Centrum Zdrowia Metabolicznego Pawel Bogdanski
    • Lesser Poland Voivodeship
      • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
        • Medicome Sp. z o. o.
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-718
        • Ekamed
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
      • Gdynia, Pomeranian Voivodeship, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
      • Aurora, Colorado, United States, 80045
        • Clinical & Translational Research Center
    • Florida
      • Jacksonville, Florida, United States, 32205
        • Westside Center for Clinical Research
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Saint Augustine, Florida, United States, 32086
        • St Johns Center for Clinical Research
    • Georgia
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, LLC
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Accellacare - Wilmington
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • AMR Clinical
      • Norman, Oklahoma, United States, 73069
        • Cornerstone Nutrition and Diabetes
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Capital Area Research, LLC
    • Texas
      • Austin, Texas, United States, 78749
        • Texas Diabetes & Endocrinology, P.A.
      • Austin, Texas, United States, 78704
        • Elligo Clinical Research Center
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • Utah
      • St. George, Utah, United States, 84790
        • Chrysalis Clinical Research
      • St. George, Utah, United States, 84790
        • Southwest Internal Medicine, PC
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Selma Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Taken once daily
Experimental: PF-07976016 Dose 1
Drug: PF-07976016
Taken once daily
Experimental: PF-07976016 Dose 2
Drug: PF-07976016
Taken once daily
Experimental: PF-07976016 Dose 3
Drug: PF-07976016
Taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in body weight
Time Frame: Baseline to Week 16
Baseline to Week 16

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2024

Primary Completion (Actual)

October 23, 2025

Study Completion (Actual)

January 12, 2026

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C5541010
  • 2024-513679-42-00 (Registry Identifier: CTIS (EU))

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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