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

NCT07876531 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: C64910172025-524803-65-002025
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and/or Obesity; Healthy Participants

Keywords

overweight; obesity; healthy

Outcome Measures

Primary Outcomes (2)

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

  Up to 85 days

• PK: Maximum Observed Concentration (Cmax) of Berobenatide

  Up to 85 days

Secondary Outcomes (1)

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

  Up to 85 Days

Study Arms (4)

Treatment 1

EXPERIMENTAL

Dosing subcutaneous berobenatide Reference Delivery System 1

Drug: Berobenatide

Treatment 2

EXPERIMENTAL

Dosing subcutaneous berobenatide Reference Delivery System 2

Drug: Berobenatide

Treatment 3

EXPERIMENTAL

Dosing subcutaneous berobenatide Test Delivery System 1

Drug: Berobenatide

Treatment 4

EXPERIMENTAL

Dosing subcutaneous berobenatide Test Delivery System 2

Drug: Berobenatide

Interventions

Berobenatide DRUG

Solution for Injection

Also known as: PF-08653944

Treatment 1; Treatment 2; Treatment 3; Treatment 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start: October 16, 2026
• Primary Completion (Estimated): April 6, 2027
• Study Completion (Estimated): April 6, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)