Single-dose PF-08653944 in adults with normal or reduced liver function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.