RecruitingRecruiting
A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity
NCT07595549 · Pfizer
In plain English
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Official title
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)
About this study
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.
Eligibility criteria
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 design
Enrollment target: 954 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-06-10
Estimated completion: 2028-06-21
Last updated: 2026-09-04
Interventions
Drug: PF-08653944Other: Placebo
Primary outcomes
- • Percent change from baseline in body weight (Baseline, Week 72)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (50)
San Fernando Valley Health InstituteRecruiting
Canoga Park, California, United States
Headlands Research California, LLCRecruiting
Escondido, California, United States
ImmuniMet, LLCRecruiting
Modesto, California, United States
Clinical Trials ResearchRecruiting
Sacramento, California, United States
University Clinical Investigators, Inc.Recruiting
Tustin, California, United States
Diablo Clinical Research, Inc.Recruiting
Walnut Creek, California, United States
Southern California Retina SpecialistsRecruiting
West Hills, California, United States
Nature Coast Clinical ResearchRecruiting
Crystal River, Florida, United States
West Coast Eye InstituteRecruiting
Lecanto, Florida, United States
South Broward ResearchRecruiting
Miramar, Florida, United States
Suncoast Clinical Research, Inc.Recruiting
New Port Richey, Florida, United States
West Coast Medical AssociatesRecruiting
New Port Richey, Florida, United States
Center for Diabetes, Obesity and Metabolism IncRecruiting
Pembroke Pines, Florida, United States
Cedar Crosse Research CenterRecruiting
Chicago, Illinois, United States
Northwestern UniversityNot Yet Recruiting
Chicago, Illinois, United States
Endeavor Health - Family Medicine AdministrationRecruiting
Evanston, Illinois, United States
Endeavor Health- Endocrinology ResearchRecruiting
Skokie, Illinois, United States
MediSphere Medical Research Center, LLCRecruiting
Evansville, Indiana, United States
Monroe Biomedical ResearchRecruiting
Louisville, Kentucky, United States
Ascension Saint Agnes Heart CareNot Yet Recruiting
Baltimore, Maryland, United States
Aa Mrc LlcRecruiting
Flint, Michigan, United States
University Of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Albuquerque Clinical Trials, Inc.Recruiting
Albuquerque, New Mexico, United States
Weill Cornell Medicine - Comprehensive Weight Control CenterRecruiting
New York, New York, United States
Rochester Clinical Research, LLCRecruiting
Rochester, New York, United States
Medication Management LLCRecruiting
Greensboro, North Carolina, United States
Accellacare - WilmingtonRecruiting
Wilmington, North Carolina, United States
Jeffrey Coleman, ODRecruiting
Wilmington, North Carolina, United States
Midwest Eye CenterRecruiting
Cincinnati, Ohio, United States
Velocity Clinical Research, Mt. AuburnRecruiting
Cincinnati, Ohio, United States
PlanIt Research, LLC (Monitoring Room)Recruiting
Houston, Texas, United States
PlanIt Research, LLCRecruiting
Houston, Texas, United States
VIP TrialsRecruiting
San Antonio, Texas, United States
York Clinical Research, LLCRecruiting
Norfolk, Virginia, United States
Saraiva & Berlinger Ltda EPP Instituto de Pesquisa Clínica de CampinasNot Yet Recruiting
Campinas, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio PretoNot Yet Recruiting
São José do Rio Preto, São Paulo, Brazil
CEPIC - Centro Paulista de Investigação ClínicaNot Yet Recruiting
São Paulo, Brazil
Ocean West Research ClinicRecruiting
Surrey, British Columbia, Canada
GA Research Associates Ltd.Recruiting
Moncton, New Brunswick, Canada
Winterberry Research Inc.Recruiting
Hamilton, Ontario, Canada
The Wharton Medical Clinic Clinical Trials IncRecruiting
Hamilton, Ontario, Canada
Canadian Phase Onward Inc.Recruiting
Toronto, Ontario, Canada
Medical Corporation Heishinkai OCROM ClinicRecruiting
Suita, Osaka, Japan
Tokyo Center ClinicRecruiting
Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-Building ClinicRecruiting
Chuo-ku, Tokyo, Japan
Fukuwa ClinicRecruiting
Chuo-ku, Tokyo, Japan
Medical Corporation Heishinkai ToCROM ClinicRecruiting
Shinjuku-ku, Tokyo, Japan
Konyang University HospitalNot Yet Recruiting
Daejeon, Daejeon, South Korea
Pusan National University Yangsan HospitalNot Yet Recruiting
Yangsan, Gyeongsangnam-do, South Korea
Gachon University Gil Medical CenterNot Yet Recruiting
Incheon, Incheon-gwangyeoksi, South Korea