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Not yet recruitingNCT07845500Updated Sep 29, 2026

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

A Phase 3 interventional study of Semaglutide and Tirzepatide in Obesity, Overweight and/or Obesity and Overweight, sponsored by Pfizer. Not yet recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
660
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight and/or Obesity
  • Overweight
  • Treatment Of Obesity

Keywords

  • nutrition disorder
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
660 participants (estimated)

Study arms

  • Active comparator
    Active Comparator

    Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection.

    Drug: Semaglutide · Drug: Tirzepatide

  • Experimental
    Experimental

    Participants will receive Berobenatide by Subcutaneous Injection.

    Drug: Berobenatide

Interventions

  • DrugSemaglutide

    Participants will receive Semaglutide administered subcutaneously.

  • DrugTirzepatide

    Participants will receive Tirzepatide administered subcutaneously.

  • DrugBerobenatide

    Participants will receive berobenatide solution for injection as subcutaneous injection.

    Also known as: MET097, PF-08653944

05

What researchers measure

Primary outcomes

  1. Percent change from baseline in body weight

    Time frame: Baseline, Week 32

Secondary outcomes

  1. Change from baseline in body weight

    Time frame: Baseline, Week 32

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Baseline, Week 32

  3. Number of Participants with Serious adverse events (SAEs)

    Time frame: Baseline, Week 32

  4. Number of Participants with adverse events leading to discontinuation

    Time frame: Baseline, Week 32

  5. Number of Participants with Adverse Events of Special Interest (AESIs)

    Time frame: Baseline, Week 32

  6. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Baseline, Week 32

06

Study locations

8 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • Suncoast Clinical Research
    New Port Richey, Florida 34652, United States
  • Monroe Biomedical Research
    Louisville, Kentucky 40213, United States
  • Aa Mrc Llc
    Flint, Michigan 48504, United States
  • Clinical Research Professionals
    Chesterfield, Missouri 63005, United States
  • Mercury Street Medical Group, PLLC
    Butte, Montana 59701, United States
  • Accellacare - Wilmington
    Wilmington, North Carolina 28401, United States
  • Velocity Clinical Research, Mt. Auburn
    Cincinnati, Ohio 45219, United States
07

References and documents

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

08

Registry details

Key details

Study ID
NCT07845500
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Feb 16, 2028 (estimated)
Completion
Feb 16, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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