A 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

What Was Tested

In this phase 3 trial, researchers set out to test Tirzepatide and Semaglutide.

The study does not include people with diabetes.

Participants will be in the study for about 11 months.

It had two arms (groups): Active Comparator (active comparator) and Experimental (experimental).

Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection.

Participants will receive Berobenatide by Subcutaneous Injection.

The registry classes the interventions as drug.

Who Took Part

The registry lists 660 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged ≥18 years. Currently taking semaglutide or tirzepatide for obesity management.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: 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).

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Tirzepatide study did not mask who received what.

It started in 2026-09-30 with completion listed for 2028-02-16.

It ran at 16 sites in United States (16).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent change from baseline in body weight (time frame: Baseline, Week 32).

It also tracked 6 secondary outcomes, for example Change from baseline in body weight, Number of Participants With Treatment Emergent Adverse Events (TEAEs), Number of Participants with Serious adverse events (SAEs), Number of Participants with adverse events leading to discontinuation, Number of Participants with Adverse Events of Special Interest (AESIs) and Number of Participants with Clinical Laboratory Abnormalities.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Semaglutide in 660 people.

With 660 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Semaglutide compound page, all human trials.