Recruiting
Phase 1

PF-08653944

Sponsor:

Pfizer

Code:

NCT07519135

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

PF-08653944

Study Details

Brief summary:

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.

Conditions

Healthy

Study ID

NCT07519135

Start date

Apr 15, 2026

Status verified date

Apr, 2026

Completion date

Jul 9, 2027

Anticipated

Primary completion date

Jul 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Group 1

Participants without Hepatic Impairment (HI) will receive a single dose of PF-08653944, administered as Subcutaneous (SC) injection.

experimental: Group 2

Participants with mild HI will receive a single dose of PF-08653944, administered as SC injection.

experimental: Group 3

Participants with moderate HI will receive a single dose of PF-08653944, administered as SC injection.

experimental: Group 4

Participants with severe HI will receive a single dose of PF 08653944, administered as SC injection.

Interventions

PF-08653944

Solution for injection

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Floridian Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

Genesis Clinical Research

Recruiting

Tampa, Florida, United States, 33603

More Information

Sponsor

Pfizer

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-04-23.