GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

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

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

Lead sponsor

Merck Sharp & Dohme LLC

Asset

Efinopegdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

•Healthy volunteers

Primary endpoints

•Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide•Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last)•Cmax of Efinopegdutide

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06052566

Org study ID6024-014

Secondary IDMK-6024-014MSD

Timeline

Milestones

Study first posted2023-09-25actual

Study start2023-11-21actual

Primary completion2024-12-05actual

Study completion2024-12-05actual

Last update posted2025-10-22actual

Results first posted2025-10-22actual

Assets

Investigational agents

Efinopegdutide

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion 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.

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

18 endpoints

Primary/registry result

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

descriptive

Posted result

Group	Value (geometric_mean), hr*μg/mL	95% CI
Efinopegdutide in Participants With Moderate Hepatic Impairment	143	120 – 169
Efinopegdutide in Participants With Severe Hepatic Impairment	152	106 – 219
Efinopegdutide in Healthy-Matched Control Group	146	81.8 – 262

Geometric Mean Ratio0.9790% CI0.61 – 1.54

Geometric Mean Ratio1.0490% CI0.63 – 1.71

Primary/registry result

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

descriptive

Posted result

Group	Value (geometric_mean), hr*μg/mL	95% CI
Efinopegdutide in Participants With Moderate Hepatic Impairment	133	113 – 156
Efinopegdutide in Participants With Severe Hepatic Impairment	125	80.8 – 193
Efinopegdutide in Healthy-Matched Control Group	134	70.2 – 255

Geometric Mean Ratio0.9990% CI0.60 – 1.65

Geometric Mean Ratio0.9390% CI0.53 – 1.65

Primary/registry result

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

concentration, descriptive

Posted result

Group	Value (geometric_mean), μg/mL	95% CI
Efinopegdutide in Participants With Moderate Hepatic Impairment	0.348	0.282 – 0.429
Efinopegdutide in Participants With Severe Hepatic Impairment	0.404	0.242 – 0.675
Efinopegdutide in Healthy-Matched Control Group	0.474	0.253 – 0.890

Geometric Mean Ratio0.7390% CI0.44 – 1.21

Geometric Mean Ratio0.8590% CI0.47 – 1.53

Primary/registry result

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

time to event, event

Posted result

Group	Value (median), hour	95% CI
Efinopegdutide in Participants With Moderate Hepatic Impairment	120.00	96.00 – 310.93
Efinopegdutide in Participants With Severe Hepatic Impairment	72.04	24.00 – 144.00
Efinopegdutide in Healthy-Matched Control Group	83.78	48.00 – 167.25

Primary/registry result

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

concentration, descriptive

Posted result

Group	Value (geometric_mean), hour	95% CI
Efinopegdutide in Participants With Moderate Hepatic Impairment	146	—
Efinopegdutide in Participants With Severe Hepatic Impairment	149	—
Efinopegdutide in Healthy-Matched Control Group	115	—

Primary/registry result

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

concentration, descriptive

Posted result

Group	Value (geometric_mean), L/hr	95% CI
Efinopegdutide in Participants With Moderate Hepatic Impairment	0.0491	—
Efinopegdutide in Participants With Severe Hepatic Impairment	0.0460	—
Efinopegdutide in Healthy-Matched Control Group	0.0478	—

Primary/registry result

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

descriptive

Posted result

Group	Value (geometric_mean), Liters	95% CI
Efinopegdutide in Participants With Moderate Hepatic Impairment	10.3	—
Efinopegdutide in Participants With Severe Hepatic Impairment	9.88	—
Efinopegdutide in Healthy-Matched Control Group	7.94	—

Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Cmax

concentration, descriptive

Primary/protocol endpoint

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

Tmax

descriptive

Primary/protocol endpoint

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

Half-life

descriptive

Primary/protocol endpoint

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

descriptive

Primary/protocol endpoint

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

descriptive

Secondary/registry result

Number of Participants Who Experienced an Adverse Event (AE)

Time frame:Up to 35 days

event count, event

Posted result

Group	Value (number), Participants	95% CI
Efinopegdutide in Participants With Moderate Hepatic Impairment	3	—
Efinopegdutide in Participants With Severe Hepatic Impairment	4	—
Efinopegdutide in Healthy-Matched Control Group	4	—

Secondary/registry result

Number of Participants Who Discontinued Study Intervention Due to an AE

Time frame:Up to 35 days

event count, event

Posted result

Group	Value (number), Participants	95% CI
Efinopegdutide in Participants With Moderate Hepatic Impairment	0	—
Efinopegdutide in Participants With Severe Hepatic Impairment	0	—
Efinopegdutide in Healthy-Matched Control Group	0	—

Secondary/protocol endpoint

Number of Participants Who Experienced an Adverse Event (AE)

Time frame:Up to 35 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants Who Discontinued Study Intervention Due to an AE

Time frame:Up to 35 days

Discontinuation due to AE

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.