Single-dose PF-08653944 in adults with normal or 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 test gives one injection of PF-08653944 to adults with normal or reduced liver function to see how the body handles the drug and to check safety.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Pfizer (industry)
• Locations: 3 sites (Miami Lakes, Florida and 2 other locations)
• Trial ID: NCT07519135 on ClinicalTrials.gov

What this trial studies

Adults aged 18–75 with normal liver function and with mild, moderate, or severe stable hepatic impairment (Child-Pugh A–C) receive a single injection of PF-08653944. Participants remain at the clinic briefly for dosing and intensive blood sampling and return for follow-up visits for safety checks, labs, and physical exams. Researchers compare drug concentrations and safety measures across the liver-function groups to determine how impairment affects drug exposure. The study excludes people with recent serious medical or psychiatric issues and those using GLP-1 receptor agonists within the specified washout period.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 who meet the BMI and weight criteria and either have normal liver function or stable Child-Pugh class A, B, or C hepatic impairment.

Not a fit: Participants should not expect direct medical benefit because this is a single-dose pharmacokinetic and safety study.

Why it matters

Potential benefit: If successful, results could help doctors choose safe dosing of PF-08653944 for people with different degrees of liver impairment.

How similar studies have performed: Similar hepatic impairment pharmacokinetic studies are routinely used and have successfully guided dosing for other drugs, though PF-08653944 remains investigational.

Eligibility criteria

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.

Where this trial is running

Miami Lakes, Florida and 2 other locations

• Floridian Clinical Research — Miami Lakes, Florida, United States (RECRUITING)
• Orlando Clinical Research Center — Orlando, Florida, United States (RECRUITING)
• Genesis Clinical Research — Tampa, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions: Healthy, Pharmacokinetics