A Study to Learn How the Study Medicine Called PF-08653944 is Taken up Into the Blood in Adults With Overweight or Obesity

May 14, 2026 updated by: Pfizer

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, PARALLEL GROUP STUDY TO ASSESS RELATIVE BIOAVAILABILITY OF PF-08653944 WHEN ADMINISTERED ACROSS DIFFERENT INJECTION SITES IN ADULTS WITH OVERWEIGHT OR OBESITY

This study is being done to learn how the study medicine affects the body and how safe it is for people who take it. The researchers will look at a number of health tests, including blood tests such as calcitonin, amylase, and lipase, because similar medicines have sometimes caused changes in these tests.

This study is seeking participants who are:

  • Adults who are obese or overweight with weight-related health conditions, and
  • Meet health and other checks assessed by the study doctor.

The study team will give a single dose of the study treatment at the clinic to the participants. At each study visit, blood samples will be collected, vital signs will be checked, and the study team will ask about any reactions or health changes. Vital signs are basic measurements that show how well the body is working. They help the study team quickly understand a participant's overall health. These usually include body temperature, heart rate, breathing rate, and blood pressure.

The study involves multiple clinic visits at a study site over the length of the study. The information collected will help researchers understand how the study medicine works and whether it is safe.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

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 Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • New Haven Clinical Research Unit

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  • Participants 18 years of age or older at Screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
  • BMI of 27-45 kg/m2 ; and a total body weight >50 kg (110 lb).
  • For Japanese participants only: BMI of 20-45 kg/m2 and a total body weight >50 kg (110 lb) and must have 4 biological Japanese grandparents who were born in Japan.

Key Exclusion Criteria:

  • Pregnant or breastfeeding women, or those planning pregnancy during the study.
  • Clinically significant medical conditions including hematologic, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis, gallbladder disease, clinically relevant gastric emptying disorders), cardiovascular, hepatic, psychiatric, neurologic, or severe allergic diseases.
  • Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC.
  • Active or recent suicidal ideation in the past year, suicidal behavior within the past 5 years, or any psychiatric condition that increases risk in the investigator's judgment.
  • Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect GI motility.
  • Acute gastrointestinal symptoms at screening or Day -1.
  • Known hypersensitivity to PF-08653944, GLP-1 receptor agonists, or any excipients.
  • Prior participation in any study involving PF-08653944 (formerly MET097) with at least one dose received.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment 1
Participants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1 administered to the abdomen.
Drug: PF-08653944
Solution for injection
Other Names:
  • MET097
Experimental: Treatment 2
Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the thigh.
Drug: PF-08653944
Solution for injection
Other Names:
  • MET097
Experimental: Treatment 3
Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the upper arm.
Drug: PF-08653944
Solution for injection
Other Names:
  • MET097
Experimental: Treatment 4 (Optional)
Japanese participants will receive a single SC dose of PF-08653944 on Day 1 administered to the abdomen.
Drug: PF-08653944
Solution for injection
Other Names:
  • MET097

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944
Time Frame: Up to 85 days
To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen
Up to 85 days
PK: Maximum Observed Concentration (Cmax) of PF-08653944
Time Frame: Up to 85 days
To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen
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)

February 4, 2026

Primary Completion (Estimated)

September 18, 2026

Study Completion (Estimated)

September 18, 2026

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6491016

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

product manufactured in and exported from the U.S.

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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