NCT07519135 · Pfizer
A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function
What this study is about
This study is being done to learn more about an experimental 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Miami Lakes, Florida
- Orlando, Florida
- Tampa, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations