NCT07845500

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for phase_3 obesity

Timeline
17mo left

Started Oct 2026

Shorter than P25 for phase_3 obesity

Geographic Reach
1 country

8 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Feb 2028

First Submitted

Initial submission to the registry

September 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2028

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

1.4 years

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

ObesityOverweight and/or ObesityOverweightTreatment Of Obesity

Keywords

nutrition disorder

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in body weight

    Baseline, Week 32

Secondary Outcomes (6)

  • Change from baseline in body weight

    Baseline, Week 32

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Baseline, Week 32

  • Number of Participants with Serious adverse events (SAEs)

    Baseline, Week 32

  • Number of Participants with adverse events leading to discontinuation

    Baseline, Week 32

  • Number of Participants with Adverse Events of Special Interest (AESIs)

    Baseline, Week 32

  • +1 more secondary outcomes

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection.

Drug: SemaglutideDrug: Tirzepatide

Experimental

EXPERIMENTAL

Participants will receive Berobenatide by Subcutaneous Injection.

Drug: Berobenatide

Interventions

SemaglutideDRUG

Participants will receive Semaglutide administered subcutaneously.

Active Comparator
TirzepatideDRUG

Participants will receive Tirzepatide administered subcutaneously.

Active Comparator
BerobenatideDRUG

Participants will receive berobenatide solution for injection as subcutaneous injection.

Also known as: MET097, PF-08653944
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

Location

Monroe Biomedical Research

Louisville, Kentucky, 40213, United States

Location

Aa Mrc Llc

Flint, Michigan, 48504, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Velocity Clinical Research, Mt. Auburn

Cincinnati, Ohio, 45219, United States

Location

Related Links

MeSH Terms

Conditions

ObesityOverweightNutrition Disorders

Interventions

semaglutideTirzepatide

Condition Hierarchy (Ancestors)

OvernutritionNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, Peptide

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 29, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 16, 2028

Study Completion (Estimated)

February 16, 2028

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

More information

Locations

US(8)