Clinical trial NCT06052566: A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Efinopegdutide (MK-6024) in Participants With Moderate and Severe Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-alcoholic Steatohepatitis
Hepatic Impairment
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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.

Primary outcomes:
measure: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide
timeFrame: Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
measure: Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide
timeFrame: Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
measure: Maximum Plasma Concentration (Cmax) of Efinopegdutide
timeFrame: Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
measure: Time to Maximum Concentration (Tmax) of Efinopegdutide
timeFrame: Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
measure: Apparent Total Clearance (CL/F) of Efinopegdutide
timeFrame: Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
measure: Apparent Volume of Distribution (Vz/F) of Efinopegdutide
timeFrame: Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 35 days
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 35 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami ( Site 0005)
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC ( Site 0001)
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC ( Site 0006)
state: Florida
city: San Antonio
country: United States
facility: American Research Corporation ( Site 0002)
state: Texas
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: