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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-alcoholic Steatohepatitis, Hepatic Impairment

Intervention / Treatment
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* Drug: Efinopegdutide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Efinopegdutide in Participants with Moderate Hepatic Impairment<br>Participants with moderate hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection. | Drug: Efinopegdutide<br>* Subcutaneous injection administered at a dose of 7 mg<br>* Other names: JNJ-64565111;|
| Experimental: Efinopegdutide in Participants with Severe Hepatic Impairment<br>Participants with severe hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. | Drug: Efinopegdutide<br>* Subcutaneous injection administered at a dose of 7 mg<br>* Other names: JNJ-64565111;|
| Experimental: Efinopegdutide in Healthy-Matched Control Group<br>Healthy matched participants receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. | Drug: Efinopegdutide<br>* Subcutaneous injection administered at a dose of 7 mg<br>* Other names: JNJ-64565111;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose will be used to determine the AUC0-inf. | Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 | 
| Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose will be used to determine the AUC0-last. | Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 | 
| Maximum Plasma Concentration (Cmax) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose will be used to determine the Cmax. | Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 | 
| Time to Maximum Concentration (Tmax) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose will be used to determine the t½. | Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 | 
| Apparent Total Clearance (CL/F) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose will be used to determine the CL/F. | Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 | 
| Apparent Volume of Distribution (Vz/F) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose will be used to determine the Vz/F. | Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 35 days | 
| Number of Participants Who Discontinue Study Intervention Due to an AE | 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. | Up to approximately 35 days |