Phase 1
Completed N=22
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
Non-alcoholic Steatohepatitis · Hepatic Impairment
Source: ClinicalTrials.gov NCT06052566 ↗
Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Oct 2025
Primary outcomePrimary: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide — 143; 152; 146 hr*μg/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide |
143; 152; 146 | — |
| PRIMARY Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide |
133; 125; 134 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Efinopegdutide |
0.348; 0.404; 0.474 | — |
| PRIMARY Time to Maximum Concentration (Tmax) of Efinopegdutide |
120.00; 72.04; 83.78 | — |
| PRIMARY Apparent Terminal Half-life (t/12) of Efinopegdutide |
146; 149; 115 | — |
| PRIMARY Apparent Total Clearance (CL/F) of Efinopegdutide |
0.0491; 0.0460; 0.0478 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of Efinopegdutide |
10.3; 9.88; 7.94 | — |
| SECONDARY Number of Participants Who Experienced an Adverse Event (AE) |
3; 4; 4 | — |
| SECONDARY Number of Participants Who Discontinued Study Intervention Due to an AE |
0; 0; 0 | — |
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
- 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).
Exclusion Criteria
- History of cancer (malignancy).
- 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 are positive for human immunodeficiency virus (HIV)-1 or HIV-2 at 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.
Data sourced from ClinicalTrials.gov (NCT06052566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.