NCT06717425

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Dec 2024

Geographic Reach
3 countries

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 9, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2026

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

December 2, 2024

Last Update Submit

February 4, 2026

Conditions

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in body weight

    Baseline to Week 16

Secondary Outcomes (1)

  • 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

Study Arms (4)

PF-07976016 Dose 1

EXPERIMENTAL
Drug: PF-07976016

PF-07976016 Dose 2

EXPERIMENTAL
Drug: PF-07976016

PF-07976016 Dose 3

EXPERIMENTAL
Drug: PF-07976016

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Taken once daily

PF-07976016 Dose 1PF-07976016 Dose 2PF-07976016 Dose 3

Taken once daily

Placebo

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Clinical & Translational Research Center

Aurora, Colorado, 80045, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

St Johns Center for Clinical Research

Saint Augustine, Florida, 32086, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, 66606, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

AMR Clinical

Norman, Oklahoma, 73069, United States

Location

Cornerstone Nutrition and Diabetes

Norman, Oklahoma, 73069, United States

Location

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Elligo Clinical Research Center

Austin, Texas, 78704, United States

Location

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, 78749, United States

Location

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Southwest Internal Medicine, PC

St. George, Utah, 84790, United States

Location

Selma Medical Associates

Winchester, Virginia, 22601, United States

Location

Ocean West Research Clinic

Surrey, British Columbia, V3Z 2N6, Canada

Location

Dawson Clinical Research Inc.

Guelph, Ontario, N1H 1B1, Canada

Location

The Wharton Medical Clinic Clinical Trials Inc.

Hamilton, Ontario, L8L 5G8, Canada

Location

Milestone Research Inc.

London, Ontario, N5W 6A2, Canada

Location

Canadian Phase Onward

Toronto, Ontario, M3J 0K2, Canada

Location

Centrum Zdrowia Metabolicznego Pawel Bogdanski

Poznan, Greater Poland Voivodeship, 60-589, Poland

Location

Medicome Sp. z o. o.

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

Location

Ekamed

Lublin, Lublin Voivodeship, 20-718, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized, double-blind (investigator and participant), sponsor-open, placebo-controlled study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 5, 2024

Study Start

December 9, 2024

Primary Completion

October 23, 2025

Study Completion

January 12, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

More information

Locations