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Not yet recruitingNCT07876531Updated Oct 15, 2026

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

A Phase 1 interventional study of Berobenatide in Overweight and/or Obesity and Healthy Participants, sponsored by Pfizer. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overweight and/or Obesity
  • Healthy Participants

Keywords

  • overweight
  • obesity
  • healthy
03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's planned enrollment of 144 is above the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Treatment 1

    Dosing subcutaneous berobenatide Reference Delivery System 1

    Drug: Berobenatide

  • Experimental
    Treatment 2

    Dosing subcutaneous berobenatide Reference Delivery System 2

    Drug: Berobenatide

  • Experimental
    Treatment 3

    Dosing subcutaneous berobenatide Test Delivery System 1

    Drug: Berobenatide

  • Experimental
    Treatment 4

    Dosing subcutaneous berobenatide Test Delivery System 2

    Drug: Berobenatide

Interventions

  • Solution for Injection

    Also known as: PF-08653944

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Berobenatide

    Time frame: Up to 85 days

  2. PK: Maximum Observed Concentration (Cmax) of Berobenatide

    Time frame: Up to 85 days

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 85 Days

07

Study locations

1 site
  • Anaheim Clinical Trials, LLC
    Anaheim, California 92801, United States
08

References and documents

Individual participant data

Plan to share: No — 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.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876531
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Oct 16, 2026 (estimated)
Primary completion
Apr 6, 2027 (estimated)
Completion
Apr 6, 2027 (estimated)
Last update
Oct 15, 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
No
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 Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Berobenatide

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