Active not recruitingPhase 1

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

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

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 27-45•Healthy volunteers

Primary endpoints

•AUC of PF-08653944•PK: Maximum Observed Concentration (Cmax) of PF-08653944

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07400679

Org study IDC6491016

Timeline

Milestones

Study start2026-02-04actual

Study first posted2026-02-10actual

Last update posted2026-05-18actual

Primary completion2026-09-18estimated

Study completion2026-09-18estimated

Assets

Investigational agents

MET097 / PF-08653944

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

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.

Endpoints (3)

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

3 endpoints

Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944

Time frame:Up to 85 days

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Concentration (Cmax) of PF-08653944

Time frame:Up to 85 days

concentration, descriptive

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to 85 Days

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.