Recruiting
Phase 3

Berobenatide

Sponsor:

Pfizer

Code:

NCT07595549

Conditions

Obesity

Overweight and/or Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08653944

Placebo

Study Details

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.

Conditions

Obesity

Overweight and/or Obesity

Overweight

Study ID

NCT07595549

Start date

Jun 10, 2026

Status verified date

Sep, 2026

Completion date

Jun 21, 2028

Anticipated

Primary completion date

May 4, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

954 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

PF-08653944

By Subcutaneous Injection

Placebo

By Subcutaneous Injection

Primary outcome measure

  • Percent change from baseline in body weight [ Time Frame: Baseline, Week 72 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

San Fernando Valley Health Institute

Recruiting

Canoga Park, California, United States, 91304

Headlands Research California, LLC

Recruiting

Escondido, California, United States, 92025

ImmuniMet, LLC

Recruiting

Modesto, California, United States, 95350

Clinical Trials Research

Recruiting

Sacramento, California, United States, 95821

University Clinical Investigators, Inc.

Recruiting

Tustin, California, United States, 92780

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Southern California Retina Specialists

Recruiting

West Hills, California, United States, 91307

Nature Coast Clinical Research

Recruiting

Crystal River, Florida, United States, 34429

West Coast Eye Institute

Recruiting

Lecanto, Florida, United States, 34461

South Broward Research

Recruiting

Miramar, Florida, United States, 33027

Suncoast Clinical Research, Inc.

Recruiting

New Port Richey, Florida, United States, 34652

West Coast Medical Associates

Recruiting

New Port Richey, Florida, United States, 34652

Center for Diabetes, Obesity and Metabolism Inc

Recruiting

Pembroke Pines, Florida, United States, 33024

Cedar Crosse Research Center

Recruiting

Chicago, Illinois, United States, 60607

Endeavor Health - Family Medicine Administration

Recruiting

Evanston, Illinois, United States, 60201

Endeavor Health- Endocrinology Research

Recruiting

Skokie, Illinois, United States, 60077

MediSphere Medical Research Center, LLC

Recruiting

Evansville, Indiana, United States, 47714

Monroe Biomedical Research

Recruiting

Louisville, Kentucky, United States, 40213

Aa Mrc Llc

Recruiting

Flint, Michigan, United States, 48504

University Of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Albuquerque Clinical Trials, Inc.

Recruiting

Albuquerque, New Mexico, United States, 87102

Weill Cornell Medicine - Comprehensive Weight Control Center

Recruiting

New York, New York, United States, 10021

Rochester Clinical Research, LLC

Recruiting

Rochester, New York, United States, 14609

Medication Management LLC

Recruiting

Greensboro, North Carolina, United States, 27405

Accellacare - Wilmington

Recruiting

Wilmington, North Carolina, United States, 28401

Jeffrey Coleman, OD

Recruiting

Wilmington, North Carolina, United States, 28401

Midwest Eye Center

Recruiting

Cincinnati, Ohio, United States, 45202

Velocity Clinical Research, Mt. Auburn

Recruiting

Cincinnati, Ohio, United States, 45219

PlanIt Research, LLC (Monitoring Room)

Recruiting

Houston, Texas, United States, 77079

PlanIt Research, LLC

Recruiting

Houston, Texas, United States, 77079

VIP Trials

Recruiting

San Antonio, Texas, United States, 78230

York Clinical Research, LLC

Recruiting

Norfolk, Virginia, United States, 23504

Ocean West Research Clinic

Recruiting

Surrey, British Columbia, Canada, V3Z2N6

GA Research Associates Ltd.

Recruiting

Moncton, New Brunswick, Canada, E1G 1A7

Winterberry Research Inc.

Recruiting

Hamilton, Ontario, Canada, L8J 0B6

The Wharton Medical Clinic Clinical Trials Inc

Recruiting

Hamilton, Ontario, Canada, L8L 5G8

Canadian Phase Onward Inc.

Recruiting

Toronto, Ontario, Canada, M3J 0K2

More Information

Sponsor

Pfizer

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Overnutrition
  • Nutrition Disorders
  • Diabetes Mellitus, Type 2
  • Type 2 Diabetes
  • Body Weight
  • Diabetes Mellitus
  • Glucose Metabolism Disorders
  • Endocrine System Diseases
  • Overweight
  • Obesity
  • Nutritional and Metabolic Diseases
  • Signs and Symptoms
  • Pathological Conditions, Signs and Symptoms
  • Metabolic Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-04.