A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity

November 4, 2026 updated by: Pfizer

PHASE 1, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, PARALLEL GROUP, PK COMPARABILITY STUDY BETWEEN DIFFERENT DELIVERY SYSTEMS OF BEROBENATIDE IN ADULTS WITH OVERWEIGHT OR OBESITY

This is a single dose study to learn how safe and effective the study medicine is using different delivery systems for adults with overweight or obesity. Overweight or obesity means having more body fat than what is healthy.

The study involves multiple clinic visits at a study site over the length of the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Anaheim Clinical Trials, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Participants 18 years of age or older
  • BMI of 27-45 kg/m2; and a total body weight >50 kg (110 lb)

Key Exclusion Criteria:

  • Pregnant or breastfeeding women, or those planning pregnancy during the study
  • History of other chronic disorders
  • Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC
  • Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect gastrointestinal (GI) motility
  • Acute GI symptoms at screening, Day -1, or prior to administration of study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment 1

Dosing subcutaneous berobenatide Reference Delivery System 1
Drug: Berobenatide

Solution for Injection

Other Names:
  • PF-08653944
Experimental: Treatment 2

Dosing subcutaneous berobenatide Reference Delivery System 2
Drug: Berobenatide

Solution for Injection

Other Names:
  • PF-08653944
Experimental: Treatment 3

Dosing subcutaneous berobenatide Test Delivery System 1
Drug: Berobenatide

Solution for Injection

Other Names:
  • PF-08653944
Experimental: Treatment 4

Dosing subcutaneous berobenatide Test Delivery System 2
Drug: Berobenatide

Solution for Injection

Other Names:
  • PF-08653944

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Berobenatide
Time Frame: Up to 85 days
Up to 85 days
PK: Maximum Observed Concentration (Cmax) of Berobenatide
Time Frame: Up to 85 days
Up to 85 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 85 Days
Up to 85 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2026

Primary Completion (Estimated)

April 6, 2027

Study Completion (Estimated)

April 6, 2027

Study Registration Dates

First Submitted

October 9, 2026

First Submitted That Met QC Criteria

October 9, 2026

First Posted (Actual)

October 15, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6491017
  • 2025 (U.S. NIH Grant/Contract)
  • 2025-524803-65-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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