Recruiting

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

ClinicalTrials.gov IDNCT07595549

PhasePHASE3

Enrollment954

SponsorPfizer

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Obesity, Overweight and/or Obesity, Overweight

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.

Interventions

Drug: PF-08653944 — By Subcutaneous Injection
Other: Placebo — By Subcutaneous Injection

Primary outcomes

Percent change from baseline in body weight (Baseline, Week 72)

Eligibility information

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 locations

San Fernando Valley Health Institute, Canoga Park, California 91304 United States
Headlands Research California, LLC, Escondido, California 92025 United States
ImmuniMet, LLC, Modesto, California 95350 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
Southern California Retina Specialists, West Hills, California 91307 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

Showing 10 of 50 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.