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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-08653944

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Floridian Clinical Research
    • Orlando, Florida, United States, 32809
      • Recruiting
      • Orlando Clinical Research Center
    • Tampa, Florida, United States, 33603
      • Recruiting
      • Genesis Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Participants without Hepatic Impairment (HI) will receive a single dose of PF-08653944, administered as Subcutaneous (SC) injection.	Drug: PF-08653944; Solution for injection; Other Names: MET097
Experimental: Group 2; Participants with mild HI will receive a single dose of PF-08653944, administered as SC injection.	Drug: PF-08653944; Solution for injection; Other Names: MET097
Experimental: Group 3; Participants with moderate HI will receive a single dose of PF-08653944, administered as SC injection.	Drug: PF-08653944; Solution for injection; Other Names: MET097
Experimental: Group 4; Participants with severe HI will receive a single dose of PF 08653944, administered as SC injection.	Drug: PF-08653944; Solution for injection; Other Names: MET097

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): July 9, 2027

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 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

• Keywords: Pharmacokinetics
• Other Study ID Numbers: C6491009; MET097-25-105 (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