Skip to main content
OpenTrials
Completed

NCT Number: NCT06052566

A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Pharma CR, LLC ( Site 0001), Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Efinopegdutide

Drug

Subcutaneous injection administered at a dose of 7 mg

Other names: MK-6024, HM12525A, JNJ-64565111

Primary outcomes

  1. Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide

    Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35

    Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.

  2. Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide

    Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35

    Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-last.

  3. Maximum Plasma Concentration (Cmax) of Efinopegdutide

    Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35

    Blood samples collected at multiple timepoints post-dose were used to determine the Cmax.

  4. Time to Maximum Concentration (Tmax) of Efinopegdutide

    Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35

    Blood samples collected at multiple timepoints post-dose were used to determine the Tmax of efinopegdutide.

  5. Apparent Terminal Half-life (t/12) of Efinopegdutide

    Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35

    Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.

  6. Apparent Total Clearance (CL/F) of Efinopegdutide

    Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35

    Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.

  7. Apparent Volume of Distribution (Vz/F) of Efinopegdutide

    Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35

    Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F.

Secondary outcomes

  1. Number of Participants Who Experienced an Adverse Event (AE)

    Time frame: Up to 35 days

    An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.

  2. Number of Participants Who Discontinued Study Intervention Due to an AE

    Time frame: Up to 35 days

    An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Efinopegdutide (MK-6024) in Participants With Moderate and Severe Hepatic Impairment

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2023
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.