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| ID | Type | Description | Link |
|---|---|---|---|
| MET097-25-105 | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants without Hepatic Impairment (HI) will receive a single dose of PF-08653944, administered as Subcutaneous (SC) injection. |
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| Group 2 | Experimental | Participants with mild HI will receive a single dose of PF-08653944, administered as SC injection. |
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| Group 3 | Experimental | Participants with moderate HI will receive a single dose of PF-08653944, administered as SC injection. |
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| Group 4 | Experimental | Participants with severe HI will receive a single dose of PF 08653944, administered as SC injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08653944 | Drug | Solution for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) of PF-08653944 | Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention. | |
| PK: Area under the plasma concentration (AUC) of PF-08653944 | Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | First dose through study completion, approximately 11 Weeks after last dose of study intervention. |
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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):
Groups 2-4 (with hepatic impairment):
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Floridian Clinical Research | Recruiting | Miami Lakes | Florida | 33016 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Orlando Clinical Research Center |
| Recruiting |
| Orlando |
| Florida |
| 32809 |
| United States |
| Genesis Clinical Research | Recruiting | Tampa | Florida | 33603 | United States |