DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07519135

RecruitingPhase 1

A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-08653944 IN ADULTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIRMENT

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

3

Recruiting sites

3

Enrollment

26

estimated

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

•BMI ≥21

Primary endpoints

•Cmax of PF-08653944•PK: Area under the plasma concentration (AUC) of PF-08653944

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 IDNCT07519135
Org study IDC6491009
Secondary IDMET097-25-105Alias Study Number

Timeline

Milestones

Study first posted2026-04-09actual
Study start2026-04-15actual
Last update posted2026-04-23actual
Primary completion2027-07-09estimated
Study completion2027-07-09estimated

Assets

Investigational agents

MET097 / PF-08653944

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age74 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Adults 18 to 75 years of age, male or female.
•BMI ≥21 kg/m² and body weight >50 kg at screening.
•Group 1 (without hepatic impairment):
–No known or suspected hepatic impairment.
–Normal liver function tests (ALT, AST, bilirubin, albumin, PT within normal limits, with protocol-specified exceptions such as Gilbert's syndrome).
•Groups 2-4 (with hepatic impairment):
–Stable hepatic impairment classified as Child-Pugh Class A (mild), B (moderate), or C (severe).
–No clinically significant worsening of hepatic status within 28 days prior to screening.
•Women of childbearing potential must not be pregnant or breastfeeding and must agree to use highly effective contraception.

Exclusion criteria

•Clinically significant medical or psychiatric conditions, including recent or active suicidal ideation or behavior.
•Use of GLP-1 receptor agonists within 90 days (or 5 half-lives) prior to dosing.
•Participation in another investigational study or receipt of an investigational product within 30 days (or 5 half-lives) prior to dosing.
•For hepatic-impairment groups only:
–Hepatic carcinoma, hepatorenal syndrome, or limited life expectancy.
–Clinically active Grade 3 or 4 hepatic encephalopathy.
–Severe uncontrolled ascites, recent gastrointestinal bleeding, or history of solid organ transplant.

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): Maximum observed plasma concentration (Cmax) of PF-08653944

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

concentration, descriptive

Primary/protocol endpoint

PK: Area under the plasma concentration (AUC) of PF-08653944

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

concentration, descriptive

Secondary/protocol endpoint

Number of participants with Treatment Emergent Adverse Events (TEAEs)

Time frame:First dose through study completion, approximately 11 Weeks after last dose of study intervention.

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.