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

Last updated: December 13, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

1

Condition

Liver Disease

Primary Biliary Cholangitis

Treatment

Efinopegdutide

Clinical Study ID

NCT06052566
6024-014
MK-6024-014
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.

Eligibility Criteria

Inclusion

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 orbreastfeeding, is not a participant of childbearing potential (POCBP), or is a POCBPand agrees to follow contraceptive guidance during the study intervention period andfor at least 35 days after the last dose of study intervention.

  • For participants with moderate or severe hepatic impairment: Have a diagnosis ofchronic (>6 months), stable, hepatic impairment with features of cirrhosis due toany etiology (stability of hepatic disease should correspond to no acute episodes ofillness within the previous 2 months due to deterioration in hepatic function).

Exclusion

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 humanimmunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit.

  • Participants with moderate or severe hepatic impairment who received antiviraland/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 anymedication, including prescription and nonprescription drugs or herbal remediesbeginning approximately 2 weeks (or 5 half-lives) prior to administration of theinitial dose of study intervention, throughout the study (including washoutintervals between treatment periods), until the poststudy visit.

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: Efinopegdutide
Phase: 1
Study Start date:
November 21, 2023
Estimated Completion Date:
December 05, 2024

Connect with a study center

  • Advanced Pharma CR, LLC ( Site 0001)

    Miami, Florida 33147
    United States

    Site Not Available

  • Clinical Pharmacology of Miami ( Site 0005)

    Miami, Florida 33014-3616
    United States

    Site Not Available

  • Genesis Clinical Research, LLC ( Site 0006)

    Tampa, Florida 33603
    United States

    Site Not Available

  • American Research Corporation ( Site 0002)

    San Antonio, Texas 78215
    United States

    Site Not Available

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