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RecruitingPhase 1

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

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

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

20

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

BMI 27-45Healthy volunteers

Primary endpoints

Acetaminophen Pharmacokinetic (PK) ParametersAcetaminophen PK parameters

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07508241
Org study IDC6491010
Secondary IDMET097-25-106Alias Study Number

Timeline

Milestones

Study start2026-03-31actual
Study first posted2026-04-02actual
Last update posted2026-04-23actual
Primary completion2027-01-27estimated
Study completion2027-01-27estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

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.

concentration, descriptive

Primary/protocol endpoint

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.

concentration, descriptive

Primary/protocol endpoint

Acetaminophen PK parameters: Time to Maximum concentration (Tmax)

Time frame:Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.

time to event, event

Secondary/protocol endpoint

Number of participants with Treatment Emergent Adverse Events (TEAEs)

Time frame:First dose through study completion, approximately 11 Weeks post last dose.

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.