NCT06052566CompletedPhase 1
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Efinopegdutide (MK-6024) in Participants With Moderate and Severe Hepatic Impairment
Source: ClinicalTrials.gov · Last updated 22 Oct 2025
Brief summary (registry, in English)
The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 18 Sept 2023
- Start date
- 21 Nov 2023
- Primary completion date
- 5 Dec 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT06052566
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 22
- From 21 Nov 2023 to the primary completion date, 5 Dec 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
- Participants with moderate or severe hepatic impairment who received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start.
- Healthy participants who are unable to refrain from or anticipate the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit.
Other illness
- History of cancer (malignancy).
- Participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit.
Who the study is looking for
- A participant assigned female at birth is eligible to participate if not pregnant or breastfeeding, is not a participant of childbearing potential (POCBP), or is a POCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 35 days after the last dose of study intervention.
- For participants with moderate or severe hepatic impairment: Have a diagnosis of chronic (\>6 months), stable, hepatic impairment with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function).
Criteria the registry did not label
- The main inclusion and exclusion criteria include but are not limited to the following:
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Advanced Pharma CR, LLC ( Site 0001) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Clinical Pharmacology of Miami ( Site 0005) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| American Research Corporation ( Site 0002) Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Genesis Clinical Research, LLC ( Site 0006) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.