Recruiting
Phase 1

Observational Study

Sponsor:

Pfizer

Code:

NCT07876531

Conditions

Overweight and/or Obesity

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Berobenatide

Study Details

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

Study ID

NCT07876531

Start date

Oct 16, 2026

Status verified date

Nov, 2026

Completion date

Apr 6, 2027

Anticipated

Primary completion date

Apr 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment 1

Dosing subcutaneous berobenatide Reference Delivery System 1

experimental: Treatment 2

Dosing subcutaneous berobenatide Reference Delivery System 2

experimental: Treatment 3

Dosing subcutaneous berobenatide Test Delivery System 1

experimental: Treatment 4

Dosing subcutaneous berobenatide Test Delivery System 2

Interventions

Berobenatide

Solution for Injection

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

Anaheim Clinical Trials, LLC

Recruiting

Anaheim, California, United States, 92801

More Information

Sponsor

Pfizer

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • overweight
  • obesity
  • healthy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Pfizer on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.