Recruiting

Phase 3

BerobenatideA Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity

Sponsor:

Pfizer

Code:

NCT07845500

Conditions

Obesity

Overweight and/or Obesity

Overweight

Treatment Of Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Berobenatide

Tirzepatide

Study Details

Brief summary:

The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes.

Participants will be in the study for about 11 months.

Conditions

Obesity

Overweight and/or Obesity

Overweight

Treatment Of Obesity

Study ID

NCT07845500

Start date

Sep 30, 2026

Status verified date

Oct, 2026

Completion date

Feb 16, 2028

Anticipated

Primary completion date

Feb 16, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Aged ≥18 years.
Currently taking semaglutide or tirzepatide for obesity management.

Exclusion Criteria:

Diagnosis of any form of diabetes.
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

660 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active Comparator

Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection.

experimental: Experimental

Participants will receive Berobenatide by Subcutaneous Injection.

Interventions

Semaglutide

Participants will receive Semaglutide administered subcutaneously.

Berobenatide

Participants will receive berobenatide solution for injection as subcutaneous injection.

Tirzepatide

Participants will receive Tirzepatide administered subcutaneously.

Primary outcome measure

Percent change from baseline in body weight [ Time Frame: Baseline, Week 32 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Monroe Biomedical Research

Recruiting

Louisville, Kentucky, United States, 40213

Clinical Research Professionals

Recruiting

Chesterfield, Missouri, United States, 63005

Mercury Street Medical Group, PLLC

Recruiting

Butte, Montana, United States, 59701

Velocity Clinical Research, Mt. Auburn

Recruiting

Cincinnati, Ohio, United States, 45219

More Information

Sponsor

Pfizer

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

nutrition disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Pfizer on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.