Non-alcoholic SteatohepatitisPhase 1NCT06052566

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

A Phase 1 study testing Efinopegdutide in people with Non-alcoholic Steatohepatitis and Hepatic Impairment, run by Merck Sharp & Dohme LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Non-alcoholic Steatohepatitis, Hepatic Impairment
What is being tested?: Efinopegdutide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 4 sitesUnited States
Study dates: 21 Nov 2023to 5 Dec 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Clinical Pharmacology of Miami ( Site 0005)
Miami, Florida, 33014-3616
Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida, 33147
American Research Corporation ( Site 0002)
San Antonio, Texas, 78215
Genesis Clinical Research, LLC ( Site 0006)
Tampa, Florida, 33603

Other trials in United States

About this study

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

Conditions: Non-alcoholic Steatohepatitis, Hepatic Impairment
Being tested: Efinopegdutide
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EfinopegdutideDrug
Also called MK-6024, HM12525A, JNJ-64565111
Subcutaneous injection administered at a dose of 7 mg

Study groups in NCT06052566
Study group	Role	What they receive
Efinopegdutide in Participants with Moderate Hepatic Impairment	Experimental	Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection. Receives: Drug: Efinopegdutide
Efinopegdutide in Participants with Severe Hepatic Impairment	Experimental	Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. Receives: Drug: Efinopegdutide
Efinopegdutide in Healthy-Matched Control Group	Experimental	Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. Receives: Drug: Efinopegdutide

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide
Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the AUC0-last.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the Cmax.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the Tmax of efinopegdutide.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Apparent Terminal Half-life (t/12) of Efinopegdutide
Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the CL/F.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 3, 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 were used to determine the Vz/F.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35

Secondary outcomes (2)

Number of Participants Who Experienced 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.
Measured: Up to 35 days
Number of Participants Who Discontinued 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.
Measured: Up to 35 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 20235 Dec 2024

First posted25 Sep 2023
Study start21 Nov 2023
Primary completion5 Dec 2024
Study completion5 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06052566
Sponsor's protocol ID: 6024-014
Other IDs: MK-6024-014
Status last verified: Oct 2025
First submitted: 18 Sep 2023
Last updated: 22 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-alcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Efinopegdutide (MK-6024) in Participants With Moderate and Severe Hepatic Impairment
ClinicalTrials.gov ID: NCT06052566
Acronym / sponsor ID: 6024-014
Conditions: Non-alcoholic Steatohepatitis, Hepatic Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 21 Nov 2023 (actual)
Primary completion: 5 Dec 2024 (actual)
Study completion: 5 Dec 2024 (actual)
First posted: 25 Sep 2023 (actual)
Results: Posted 22 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Efinopegdutide in Participants with Moderate Hepatic Impairment	Experimental	Drug: EfinopegdutideParticipants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.
Efinopegdutide in Participants with Severe Hepatic Impairment	Experimental	Drug: EfinopegdutideParticipants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Efinopegdutide in Healthy-Matched Control Group	Experimental	Drug: EfinopegdutideHealthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EfinopegdutideAlso: MK-6024, HM12525A, JNJ-64565111Subcutaneous injection administered at a dose of 7 mg	Drug	Efinopegdutide in Healthy-Matched Control Group, Efinopegdutide in Participants with Moderate Hepatic Impairment, Efinopegdutide in Participants with Severe Hepatic Impairment

Primary outcome

Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.
Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-last.
Maximum Plasma Concentration (Cmax) of Efinopegdutide
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the Cmax.
Time to Maximum Concentration (Tmax) of Efinopegdutide
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the Tmax of efinopegdutide.
Apparent Terminal Half-life (t/12) of Efinopegdutide
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.
Apparent Total Clearance (CL/F) of Efinopegdutide
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.
Apparent Volume of Distribution (Vz/F) of Efinopegdutide
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F.

2 secondary outcomes

Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 35 days
Number of Participants Who Discontinued Study Intervention Due to an AE
Time frame: Up to 35 days

Results and safety

Results posted to the registry on 22 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Efinopegdutide in Participants With Moderate Hepatic Impairment	8	8
Efinopegdutide in Participants With Severe Hepatic Impairment	8	8
Efinopegdutide in Healthy-Matched Control Group	6	6

Primary outcome: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide

Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35. Geometric mean (95% Confidence Interval). Unit: hr*μg/mL

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n = 6	Efinopegdutide in Participants With Severe Hepatic Impairment n = 7	Efinopegdutide in Healthy-Matched Control Group n = 6
Value	143 (120 to 169)	152 (106 to 219)	146 (81.8 to 262)

Efinopegdutide in Participants With Moderate Hepatic Impairment vs Efinopegdutide in Healthy-Matched Control Group: Geometric Mean Ratio: 0.97 (90% CI 0.61 to 1.54)
Efinopegdutide in Participants With Severe Hepatic Impairment vs Efinopegdutide in Healthy-Matched Control Group: Geometric Mean Ratio: 1.04 (90% CI 0.63 to 1.71)

Population analysed: All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.

Primary outcome: Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide

Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35. Geometric mean (95% Confidence Interval). Unit: hr*μg/mL

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n = 7	Efinopegdutide in Participants With Severe Hepatic Impairment n = 8	Efinopegdutide in Healthy-Matched Control Group n = 6
Value	133 (113 to 156)	125 (80.8 to 193)	134 (70.2 to 255)

Efinopegdutide in Participants With Moderate Hepatic Impairment vs Efinopegdutide in Healthy-Matched Control Group: Geometric Mean Ratio: 0.99 (90% CI 0.60 to 1.65)
Efinopegdutide in Participants With Severe Hepatic Impairment vs Efinopegdutide in Healthy-Matched Control Group: Geometric Mean Ratio: 0.93 (90% CI 0.53 to 1.65)

Primary outcome: Maximum Plasma Concentration (Cmax) of Efinopegdutide

Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n = 7	Efinopegdutide in Participants With Severe Hepatic Impairment n = 8	Efinopegdutide in Healthy-Matched Control Group n = 6
Value	0.348 (0.282 to 0.429)	0.404 (0.242 to 0.675)	0.474 (0.253 to 0.890)

Efinopegdutide in Participants With Moderate Hepatic Impairment vs Efinopegdutide in Healthy-Matched Control Group: Geometric Mean Ratio: 0.73 (90% CI 0.44 to 1.21)
Efinopegdutide in Participants With Severe Hepatic Impairment vs Efinopegdutide in Healthy-Matched Control Group: Geometric Mean Ratio: 0.85 (90% CI 0.47 to 1.53)

Primary outcome: Time to Maximum Concentration (Tmax) of Efinopegdutide

Time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35. Median (Full Range). Unit: hour

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n = 7	Efinopegdutide in Participants With Severe Hepatic Impairment n = 8	Efinopegdutide in Healthy-Matched Control Group n = 6
Value	120.00 (96.00 to 310.93)	72.04 (24.00 to 144.00)	83.78 (48.00 to 167.25)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 35 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Efinopegdutide in Participants With Moderate Hepatic Impairment	1 of 8 (12.5%)	2 of 8 (25%)	0 of 8
Efinopegdutide in Participants With Severe Hepatic Impairment	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Efinopegdutide in Healthy-Matched Control Group	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Efinopegdutide in people with Non-alcoholic Steatohepatitis and Hepatic Impairment, run by Merck Sharp & Dohme LLC at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide (time frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06052566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.