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

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06052566
• Other study ID #: 6024-014
• Secondary ID: MK-6024-014
• Status: Recruiting
• Phase: Phase 1
• Start date: November 21, 2023
• Est. completion date: August 26, 2024

Study information

• Verified date: April 2024
• Source: Merck Sharp & Dohme LLC
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 26, 2024
• Est. primary completion date: August 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Impairment
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• Efinopegdutide
Subcutaneous injection administered at a dose of 7 mg

Locations

Country	Name	City	State
United States	Advanced Pharma CR, LLC ( Site 0001)	Miami	Florida
United States	Clinical Pharmacology of Miami ( Site 0005)	Miami	Florida
United States	American Research Corporation ( Site 0002)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

•   Merck Clinical Trials Information