A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

August 14, 2026 updated by: Pfizer

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)

The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.

About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.

People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

954

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 04266-010
        • Not yet recruiting
        • CEPIC - Centro Paulista de Investigacao Clinica
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3Z2N6
        • Recruiting
        • Ocean West Research Clinic
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Not yet recruiting
        • GA Research Associates Ltd.
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G8
        • Recruiting
        • The Wharton Medical Clinic Clinical Trials Inc
      • Hamilton, Ontario, Canada, L8J 0B6
        • Not yet recruiting
        • Winterberry Research Inc.
      • Toronto, Ontario, Canada, M3J 0K2
        • Not yet recruiting
        • Canadian Phase Onward Inc.
  • Japan
    • Osaka
      • Suita, Osaka, Japan, 565-0853
        • Recruiting
        • Medical Corporation Heishinkai OCROM Clinic
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Recruiting
        • Fukuwa Clinic
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Recruiting
        • Tokyo-Eki Center-building Clinic
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Recruiting
        • Tokyo Center Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Recruiting
        • Medical Corporation Heishinkai ToCROM Clinic
  • United States
    • California
      • Canoga Park, California, United States, 91304
        • Not yet recruiting
        • San Fernando Valley Health Institute
      • Escondido, California, United States, 92025
        • Not yet recruiting
        • Headlands Research California, LLC
      • Modesto, California, United States, 95350
        • Recruiting
        • ImmuniMet, LLC
      • Roseville, California, United States, 95661
        • Recruiting
        • ClearVue Eye Care
      • Sacramento, California, United States, 95821
        • Recruiting
        • Clinical Trials Research
      • Tustin, California, United States, 92780
        • Recruiting
        • University Clinical Investigators, Inc.
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Diablo Clinical Research, Inc.
      • West Hills, California, United States, 91307
        • Not yet recruiting
        • Southern California Retina Specialists
    • Florida
      • Crystal River, Florida, United States, 34429
        • Recruiting
        • Nature Coast Clinical Research
      • Lecanto, Florida, United States, 34461
        • Recruiting
        • West Coast Eye Institute
      • Miramar, Florida, United States, 33027
        • Recruiting
        • South Broward Research
      • New Port Richey, Florida, United States, 34652
        • Recruiting
        • Suncoast Clinical Research, Inc.
      • New Port Richey, Florida, United States, 34652
        • Recruiting
        • West Coast Medical Associates
      • Pembroke Pines, Florida, United States, 33024
        • Not yet recruiting
        • Center for Diabetes, Obesity and Metabolism Inc
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Cedar Crosse Research Center
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Recruiting
        • MediSphere Medical Research Center, LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Recruiting
        • Monroe Biomedical Research
    • Michigan
      • Flint, Michigan, United States, 48504
        • Recruiting
        • Aa Mrc Llc
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Albuquerque Clinical Trials, Inc.
    • New York
      • Rochester, New York, United States, 14609
        • Recruiting
        • Rochester Clinical Research, LLC
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Medication Management LLC
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Accellacare - Wilmington
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Jeffrey Coleman, OD
    • Ohio
      • Cincinnati, Ohio, United States, 45202
        • Recruiting
        • Midwest Eye Center
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Velocity Clinical Research, Mt. Auburn
    • Texas
      • San Antonio, Texas, United States, 78230
        • Recruiting
        • VIP Trials
    • Virginia
      • Norfolk, Virginia, United States, 23504
        • Recruiting
        • York Clinical Research, LLC

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

Inclusion Criteria:

  • Aged ≥18 years.
  • BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to <30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.

Exclusion Criteria:

  • Have a self-reported body weight change greater than 5% within 90 days prior to Screening.
  • Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.
  • History of acute or chronic pancreatitis.
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).

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
Experimental: Treatment Arm 1
Participants will receive PF-08653944 by Subcutaneous Injection.
Drug: PF-08653944
By Subcutaneous Injection
Experimental: Treatment Arm 2
Participants will receive PF-08653944 by Subcutaneous Injection.
Drug: PF-08653944
By Subcutaneous Injection
Experimental: Treatment Arm 3
Participants will receive PF-08653944 by Subcutaneous Injection.
Drug: PF-08653944
By Subcutaneous Injection
Placebo Comparator: Placebo
Participants will receive matching placebo by Subcutaneous Injection.
Other: Placebo
By Subcutaneous Injection
Experimental: Treatment Arm 4
Participants will receive PF-08653944 by Subcutaneous Injection.
Drug: PF-08653944
By Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in body weight
Time Frame: Baseline, Week 72
Baseline, Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in HbA1c
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in body weight
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in waist circumference
Time Frame: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Time Frame: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Time Frame: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Time Frame: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Time Frame: Baseline, Week 72
Baseline, Week 72
Percent change from baseline in body weight in participants with type 2 diabetes
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
Time Frame: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥25% of body weight reduction from baseline
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Fasting Glucose
Time Frame: Basline, Week 72
Basline, Week 72
Change from Baseline in Fasting insulin
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting Total Cholesterol
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting Low-density lipoprotein cholesterol
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting Very low-density lipoprotein cholesterol
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting Non-High-density lipoprotein cholesterol
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting High-density lipoprotein cholesterol
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting triglycerides
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in high-sensitivity C-reactive protein
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in interleukin-6
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in interleukin-1 beta
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in IWQoL-Lite-CT total score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Physical composite score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Psychosocial composite score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from baseline in Short Form 36 health survey (SF-36) domain scales and component summary scales
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Control of Eating Questionnaire (CoEQ) subscales
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Food Noise Questionnaire (FNQ) total score
Time Frame: Baseline, Week 72
Baseline, Week 72
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline, Week 72
Baseline, Week 72
Number of Participants with Serious adverse events (SAEs)
Time Frame: Baseline, Week 72
Baseline, Week 72
Number of Participants with adverse avents leading to discontinuation
Time Frame: Baseline, Week 72
Baseline, Week 72
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame: Baseline, Week 72
Baseline, Week 72
Percentage of Participants with a waist-to-height ratio of <0.53
Time Frame: Baseline, Week 72
Baseline, Week 72

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)

June 10, 2026

Primary Completion (Estimated)

May 4, 2028

Study Completion (Estimated)

June 21, 2028

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6491013
  • VESPER-6 (Other Identifier: Alias Study Number)
  • 2026-525318-75-00 (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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