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

April 20, 2026 updated by: Pfizer

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
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.
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)
Time Frame: First dose through study completion, approximately 11 Weeks after last dose of study intervention.
First dose through study completion, approximately 11 Weeks after last dose of study intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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