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

NCT07519135 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: C6491009MET097-25-105
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose. The study includes adults with normal liver function and adults who have mild, moderate, or severe liver problems. By comparing these groups, researchers want to understand whether liver function changes how the medicine behaves in the body. People who join the study will receive one injection of the study medicine. They will stay at the study clinic for a short time and return for follow-up visits so doctors can do blood tests, physical exams, and safety checks. This study is not expected to provide direct medical benefit to participants. The information collected will help researchers develop future treatments and understand how this medicine may be used safely in people with liver disease.

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

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

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

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

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

Secondary Outcomes (1)

• Number of participants with Treatment Emergent Adverse Events (TEAEs)

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

Study Arms (4)

Group 1

EXPERIMENTAL

Participants without Hepatic Impairment (HI) will receive a single dose of PF-08653944, administered as Subcutaneous (SC) injection.

Drug: PF-08653944

Group 2

EXPERIMENTAL

Participants with mild HI will receive a single dose of PF-08653944, administered as SC injection.

Drug: PF-08653944

Group 3

EXPERIMENTAL

Participants with moderate HI will receive a single dose of PF-08653944, administered as SC injection.

Drug: PF-08653944

Group 4

EXPERIMENTAL

Participants with severe HI will receive a single dose of PF 08653944, administered as SC injection.

Drug: PF-08653944

Interventions

PF-08653944 DRUG

Solution for injection

Also known as: MET097

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

Genesis Clinical Research

Tampa, Florida, 33603, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): July 9, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)