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)
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
San Fernando Valley Health Institute
RECRUITING
Canoga Park
Headlands Research California, LLC
RECRUITING
Escondido
ImmuniMet, LLC
RECRUITING
Modesto
Clinical Trials Research
RECRUITING
Sacramento
University Clinical Investigators, Inc.
RECRUITING
Tustin
Diablo Clinical Research, Inc.
RECRUITING
Walnut Creek
Southern California Retina Specialists
RECRUITING
West Hills
Florida
Nature Coast Clinical Research
RECRUITING
Crystal River
West Coast Eye Institute
RECRUITING
Lecanto
South Broward Research
RECRUITING
Miramar
Suncoast Clinical Research, Inc.
RECRUITING
New Port Richey
West Coast Medical Associates
RECRUITING
New Port Richey
Center for Diabetes, Obesity and Metabolism Inc
RECRUITING
Pembroke Pines
Illinois
Cedar Crosse Research Center
RECRUITING
Chicago
Northwestern University
NOT_YET_RECRUITING
Chicago
Endeavor Health - Family Medicine Administration
RECRUITING
Evanston
Endeavor Health- Endocrinology Research
RECRUITING
Skokie
Indiana
MediSphere Medical Research Center, LLC
RECRUITING
Evansville
Kentucky
Monroe Biomedical Research
RECRUITING
Louisville
Maryland
Ascension Saint Agnes Heart Care
NOT_YET_RECRUITING
Baltimore
Michigan
Aa Mrc Llc
RECRUITING
Flint
North Carolina
Medication Management LLC
RECRUITING
Greensboro
Accellacare - Wilmington
RECRUITING
Wilmington
Jeffrey Coleman, OD
RECRUITING
Wilmington
Nebraska
University Of Nebraska Medical Center
RECRUITING
Omaha
New Mexico
Albuquerque Clinical Trials, Inc.
RECRUITING
Albuquerque
New York
Weill Cornell Medicine - Comprehensive Weight Control Center
RECRUITING
New York
Rochester Clinical Research, LLC
RECRUITING
Rochester
Ohio
Midwest Eye Center
RECRUITING
Cincinnati
Velocity Clinical Research, Mt. Auburn
RECRUITING
Cincinnati
Texas
PlanIt Research, LLC
RECRUITING
Houston
PlanIt Research, LLC (Monitoring Room)
RECRUITING
Houston
VIP Trials
RECRUITING
San Antonio
Virginia
York Clinical Research, LLC
RECRUITING
Norfolk
Other Locations
Brazil
Saraiva & Berlinger Ltda EPP Instituto de Pesquisa Clínica de Campinas
NOT_YET_RECRUITING
Campinas
Fundação Faculdade Regional de Medicina de São José do Rio Preto
NOT_YET_RECRUITING
São José Do Rio Preto
CEPIC - Centro Paulista de Investigação Clínica
NOT_YET_RECRUITING
São Paulo
Canada
The Wharton Medical Clinic Clinical Trials Inc
RECRUITING
Hamilton
Winterberry Research Inc.
RECRUITING
Hamilton
GA Research Associates Ltd.
RECRUITING
Moncton
Ocean West Research Clinic
RECRUITING
Surrey
Canadian Phase Onward Inc.
RECRUITING
Toronto
Japan
Fukuwa Clinic
RECRUITING
Chuo-ku
Tokyo Center Clinic
RECRUITING
Chuo-ku
Tokyo-Eki Center-Building Clinic
RECRUITING
Chuo-ku
Medical Corporation Heishinkai ToCROM Clinic
RECRUITING
Shinjuku-ku
Medical Corporation Heishinkai OCROM Clinic
RECRUITING
Suita
Republic of Korea
Konyang University Hospital
NOT_YET_RECRUITING
Daejeon
Gachon University Gil Medical Center
NOT_YET_RECRUITING
Incheon
Pusan National University Yangsan Hospital
NOT_YET_RECRUITING
Yangsan
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date:2026-06-10
Estimated Completion Date:2028-06-21
Participants
Target number of participants:954
Treatments
Experimental: Treatment Arm 1
Participants will receive PF-08653944 by Subcutaneous Injection.
Experimental: Treatment Arm 2
Participants will receive PF-08653944 by Subcutaneous Injection.
Experimental: Treatment Arm 3
Participants will receive PF-08653944 by Subcutaneous Injection.
Experimental: Treatment Arm 4
Participants will receive PF-08653944 by Subcutaneous Injection.
Placebo_comparator: Placebo
Participants will receive matching placebo by Subcutaneous Injection.