A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity
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)
3 other identifiers
interventional
954
2 countries
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Jun 2026
25 active sites
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
May 12, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedStudy Start
First participant enrolled
June 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 21, 2028
July 22, 2026
July 1, 2026
1.9 years
May 12, 2026
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change from baseline in body weight
Baseline, Week 72
Secondary Outcomes (36)
Change from baseline in body weight
Baseline, Week 72
Change from baseline in waist circumference
Baseline, Week 72
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Baseline, Week 72
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Baseline, Week 72
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Baseline, Week 72
- +31 more secondary outcomes
Study Arms (5)
Treatment Arm 1
EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Treatment Arm 2
EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Treatment Arm 3
EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Treatment Arm 4
EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Placebo
PLACEBO COMPARATORParticipants will receive matching placebo by Subcutaneous Injection.
Interventions
By Subcutaneous Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (25)
ImmuniMet, LLC
Modesto, California, 95350, United States
ClearVue Eye Care
Roseville, California, 95661, United States
Clinical Trials Research
Sacramento, California, 95821, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Nature Coast Clinical Research
Crystal River, Florida, 34429, United States
West Coast Eye Institute
Lecanto, Florida, 34461, United States
South Broward Research
Miramar, Florida, 33027, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
West Coast Medical Associates
New Port Richey, Florida, 34652, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Monroe Biomedical Research
Louisville, Kentucky, 40213, United States
Aa Mrc Llc
Flint, Michigan, 48504, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Medication Management LLC
Greensboro, North Carolina, 27405, United States
Midwest Eye Center
Cincinnati, Ohio, 45202, United States
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio, 45219, United States
VIP Trials
San Antonio, Texas, 78230, United States
York Clinical Research, LLC
Norfolk, Virginia, 23504, United States
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, 565-0853, Japan
Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Tokyo-Eki Center-Building Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008, Japan
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2026
First Posted
May 19, 2026
Study Start
June 10, 2026
Primary Completion (Estimated)
May 4, 2028
Study Completion (Estimated)
June 21, 2028
Last Updated
July 22, 2026
Record last verified: 2026-07
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.