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

Primary Purpose

Non-alcoholic Steatohepatitis, Hepatic Impairment

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Efinopegdutide
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Efinopegdutide in Participants with Moderate Hepatic Impairment

    Efinopegdutide in Participants with Severe Hepatic Impairment

    Efinopegdutide in Healthy-Matched Control Group

    Arm Description

    Participants with moderate hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.

    Participants with severe hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.

    Healthy matched participants receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    Maximum Plasma Concentration (Cmax) of Efinopegdutide
    Blood samples collected at multiple timepoints post-dose will be used to determine the Cmax.
    Time to Maximum Concentration (Tmax) of Efinopegdutide
    Blood samples collected at multiple timepoints post-dose will be used to determine the t½.
    Apparent Total Clearance (CL/F) of Efinopegdutide
    Blood samples collected at multiple timepoints post-dose will be used to determine the CL/F.
    Apparent Volume of Distribution (Vz/F) of Efinopegdutide
    Blood samples collected at multiple timepoints post-dose will be used to determine the Vz/F.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    September 18, 2023
    Last Updated
    October 3, 2023
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06052566
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 26, 2023 (Anticipated)
    Primary Completion Date
    June 26, 2024 (Anticipated)
    Study Completion Date
    June 26, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-alcoholic Steatohepatitis, Hepatic Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Efinopegdutide in Participants with Moderate Hepatic Impairment
    Arm Type
    Experimental
    Arm Description
    Participants with moderate hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.
    Arm Title
    Efinopegdutide in Participants with Severe Hepatic Impairment
    Arm Type
    Experimental
    Arm Description
    Participants with severe hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
    Arm Title
    Efinopegdutide in Healthy-Matched Control Group
    Arm Type
    Experimental
    Arm Description
    Healthy matched participants receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
    Intervention Type
    Drug
    Intervention Name(s)
    Efinopegdutide
    Other Intervention Name(s)
    MK-6024, HM12525A, JNJ-64565111
    Intervention Description
    Subcutaneous injection administered at a dose of 7 mg
    Primary Outcome Measure Information:
    Title
    Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide
    Description
    Blood samples collected at multiple timepoints post-dose will be used to determine the AUC0-inf.
    Time Frame
    Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
    Title
    Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide
    Description
    Blood samples collected at multiple timepoints post-dose will be used to determine the AUC0-last.
    Time Frame
    Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
    Title
    Maximum Plasma Concentration (Cmax) of Efinopegdutide
    Description
    Blood samples collected at multiple timepoints post-dose will be used to determine the Cmax.
    Time Frame
    Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
    Title
    Time to Maximum Concentration (Tmax) of Efinopegdutide
    Description
    Blood samples collected at multiple timepoints post-dose will be used to determine the t½.
    Time Frame
    Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
    Title
    Apparent Total Clearance (CL/F) of Efinopegdutide
    Description
    Blood samples collected at multiple timepoints post-dose will be used to determine the CL/F.
    Time Frame
    Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
    Title
    Apparent Volume of Distribution (Vz/F) of Efinopegdutide
    Description
    Blood samples collected at multiple timepoints post-dose will be used to determine the Vz/F.
    Time Frame
    Day 1, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
    Secondary Outcome Measure Information:
    Title
    Number of Participants Who Experience an Adverse Event (AE)
    Description
    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.
    Time Frame
    Up to approximately 35 days
    Title
    Number of Participants Who Discontinue Study Intervention Due to an AE
    Description
    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.
    Time Frame
    Up to approximately 35 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Links:
    URL
    https://www.merckclinicaltrials.com
    Description
    Merck Clinical Trials Information

    Learn more about this trial

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

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