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NCT Number: NCT07519135

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

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.

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Key information

Conditions

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Floridian Clinical Research, Miami Lakes, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-08653944

Drug

Solution for injection

Other names: MET097

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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