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Official title A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function
ClinicalTrials.gov ID: NCT07519135
What this study is testing
What is PF-08653944?
PF-08653944 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for healthy.
Also referred to as MET097.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74. Healthy volunteers may be eligible.
You may be able to join if
- 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).
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami Lakes, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.