Who is eligible for clinical trial NCT07519135?

Participants must meet protocol criteria for Healthy. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07519135 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-20

A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function (NCT07519135)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Pfizer

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (8 items).

Location: Floridian Clinical Research — Miami Lakes, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Floridian Clinical Research — Miami Lakes, Florida
Orlando Clinical Research Center — Orlando, Florida
Genesis Clinical Research — Tampa, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗