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Study of PF-08653944 in People With and Without Reduced Liver Function

This study is looking into a medicine called PF-08653944. Researchers want to understand how your body handles this medicine and check its safety after you receive one injection. The study includes adults aged 18 to 74, both with normal liver function and those with mild, moderate, or severe liver problems. By comparing these groups, doctors hope to learn if liver function changes how PF-08653944 works in the body. Success for this study means understanding how the medicine moves through and is cleared from the body. The study is currently unclear on its recruitment status and plans to enroll 26 people.

Study design
This is an interventional study with an unclear phase, planning to enroll 26 participants. It compares how PF-08653944 affects people with and without liver problems.
What's involved
You would receive one injection of PF-08653944, stay at a clinic for a short time, and return for follow-up visits for blood tests, physical exams, and safety checks.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for approximately 11 weeks after your last dose of the study medicine to measure its levels in your body.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07519135

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

Recruiting
PHASE1Ages 18–74InterventionalBasic science
Pfizer
~26 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:PF-08653944

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) of PF-08653944
Measured over Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
+1 more outcome measured

Conditions

Healthy

Explore related trials

Liver Failure

Where it's being run

3 sites across 1 states
Florida3

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) of PF-08653944Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
  • PK: Area under the plasma concentration (AUC) of PF-08653944Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.