A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity

April 20, 2026 updated by: Pfizer

A PHASE 1, OPEN-LABEL, MULTIPLE DOSE STUDY TO INVESTIGATE THE IMPACT OF PF 08653944 ON GASTRIC EMPTYING IN ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY

This study looks at how a study medicine called PF-08653944 affects how quickly the stomach empties food after eating. It is being done in adults who are overweight or have obesity.

Participants will receive the study medicine for a short period, and doctors will measure how the medicine moves through the stomach and monitor safety. The goal is to better understand how this medicine works in the body and to check for any side effects.

The information from this study may help researchers plan future studies of this medicine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Pfizer Clinical Research Unit - New Haven

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

Inclusion Criteria:

  • Adults ≥18 years at screening, male or female, generally healthy as determined by medical history, physical examination, laboratory tests, and ECG.
  • Body mass index (BMI) 27-45 kg/m² and body weight >50 kg (110 lb).
  • Participants with overweight or obesity

Exclusion Criteria:

  • History or presence of clinically significant medical conditions, including but not limited to:

    --Cardiovascular, hepatic, renal, pulmonary, endocrine, hematologic, neurologic, gastrointestinal (including pancreatitis or gallbladder disease), or significant psychiatric disorders.

  • Any form of diabetes, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg/dL.
  • Prior exposure to a GLP-1 receptor agonist within 90 days before first dose, or prior participation in a study with PF-08653944.

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: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Period 1
Participants will receive a single oral dose of acetaminophen.
Drug: Acetaminophen
Oral suspension
Other Names:
  • paracetamol
Experimental: Period 2
Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.
Drug: Acetaminophen
Oral suspension
Other Names:
  • paracetamol
Drug: PF-08653944
Subcutaneous Injection
Other Names:
  • MET097
Experimental: Period 3
Participants will receive SC dose of PF-0865394.
Drug: PF-08653944
Subcutaneous Injection
Other Names:
  • MET097
Experimental: Period 4
Participants will receive SC dose of PF-0865394.
Drug: PF-08653944
Subcutaneous Injection
Other Names:
  • MET097
Experimental: Period 5
Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.
Drug: Acetaminophen
Oral suspension
Other Names:
  • paracetamol
Drug: PF-08653944
Subcutaneous Injection
Other Names:
  • MET097
Experimental: Period 6
Participants will receive single SC dose of PF-08653944 and single oral dose of acetaminophen.
Drug: Acetaminophen
Oral suspension
Other Names:
  • paracetamol
Drug: PF-08653944
Subcutaneous Injection
Other Names:
  • MET097

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax)
Time Frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
Acetaminophen PK parameters: Area under the plasma concentration (AUC)
Time Frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
Acetaminophen PK parameters: Time to Maximum concentration (Tmax)
Time Frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: First dose through study completion, approximately 11 Weeks post last dose.
First dose through study completion, approximately 11 Weeks post last dose.

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)

March 31, 2026

Primary Completion (Estimated)

January 27, 2027

Study Completion (Estimated)

January 27, 2027

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6491010
  • MET097-25-106 (Other Identifier: Alias Study Number)

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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