Trial Outcomes & Findings for A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014) (NCT NCT06052566)

NCT ID: NCT06052566

Last Updated: 2025-10-22

Results Overview

Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 22 participants
• Primary outcome timeframe: 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
• Results posted on: 2025-10-22

Participant Flow

Participant milestones

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment Participants 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 Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Overall Study STARTED	8	8	6
Overall Study COMPLETED	8	8	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=8 Participants Participants 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 n=8 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Total n=22 Participants Total of all reporting groups
Age, Continuous	57.5 Years STANDARD_DEVIATION 9.5 • n=5 Participants	48.5 Years STANDARD_DEVIATION 10.5 • n=7 Participants	56.2 Years STANDARD_DEVIATION 7.1 • n=5 Participants	53.9 Years STANDARD_DEVIATION 9.8 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.

Outcome measures

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=6 Participants Participants 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 n=7 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide	143 hr*μg/mL Interval 120.0 to 169.0	152 hr*μg/mL Interval 106.0 to 219.0	146 hr*μg/mL Interval 81.8 to 262.0

PRIMARY outcome

Timeframe: 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

Population: 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.

Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-last.

Outcome measures

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=7 Participants Participants 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 n=8 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide	133 hr*μg/mL Interval 113.0 to 156.0	125 hr*μg/mL Interval 80.8 to 193.0	134 hr*μg/mL Interval 70.2 to 255.0

PRIMARY outcome

Timeframe: 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

Population: 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.

Blood samples collected at multiple timepoints post-dose were used to determine the Cmax.

Outcome measures

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=7 Participants Participants 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 n=8 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Maximum Plasma Concentration (Cmax) of Efinopegdutide	0.348 μg/mL Interval 0.282 to 0.429	0.404 μg/mL Interval 0.242 to 0.675	0.474 μg/mL Interval 0.253 to 0.89

PRIMARY outcome

Timeframe: 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

Population: 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.

Blood samples collected at multiple timepoints post-dose were used to determine the Tmax of efinopegdutide.

Outcome measures

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=7 Participants Participants 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 n=8 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Time to Maximum Concentration (Tmax) of Efinopegdutide	120.00 hour Interval 96.0 to 310.93	72.04 hour Interval 24.0 to 144.0	83.78 hour Interval 48.0 to 167.25

PRIMARY outcome

Timeframe: 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

Population: 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.

Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.

Outcome measures

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=6 Participants Participants 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 n=7 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Apparent Terminal Half-life (t/12) of Efinopegdutide	146 hour Geometric Coefficient of Variation 13.5	149 hour Geometric Coefficient of Variation 26.0	115 hour Geometric Coefficient of Variation 32.3

PRIMARY outcome

Timeframe: 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

Population: 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.

Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.

Outcome measures

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=6 Participants Participants 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 n=7 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Apparent Total Clearance (CL/F) of Efinopegdutide	0.0491 L/hr Geometric Coefficient of Variation 16.5	0.0460 L/hr Geometric Coefficient of Variation 40.8	0.0478 L/hr Geometric Coefficient of Variation 60.0

PRIMARY outcome

Timeframe: 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

Population: 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.

Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F.

Outcome measures

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=6 Participants Participants 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 n=7 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Apparent Volume of Distribution (Vz/F) of Efinopegdutide	10.3 Liters Geometric Coefficient of Variation 17.9	9.88 Liters Geometric Coefficient of Variation 57.8	7.94 Liters Geometric Coefficient of Variation 91.7

SECONDARY outcome

Timeframe: Up to 35 days

Population: All participants who received at least 1 dose of study treatment.

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.

Outcome measures

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=8 Participants Participants 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 n=8 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Number of Participants Who Experienced an Adverse Event (AE)	3 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 35 days

Population: All participants who received at least 1 dose of study treatment.

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.

Outcome measures

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=8 Participants Participants 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 n=8 Participants Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 Participants Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Number of Participants Who Discontinued Study Intervention Due to an AE	0 Participants	0 Participants	0 Participants

Adverse Events

Efinopegdutide in Participants With Moderate Hepatic Impairment

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Efinopegdutide in Participants With Severe Hepatic Impairment

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Efinopegdutide in Healthy-Matched Control Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=8 participants at risk Participants 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 n=8 participants at risk Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 participants at risk Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Injury, poisoning and procedural complications Multiple injuries	12.5% 1/8 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/6 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.

Other adverse events

Measure	Efinopegdutide in Participants With Moderate Hepatic Impairment n=8 participants at risk Participants 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 n=8 participants at risk Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Efinopegdutide in Healthy-Matched Control Group n=6 participants at risk Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	12.5% 1/8 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/6 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.
Gastrointestinal disorders Constipation	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	12.5% 1/8 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/6 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	12.5% 1/8 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	16.7% 1/6 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.
Gastrointestinal disorders Flatulence	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	33.3% 2/6 • Number of events 2 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.
Gastrointestinal disorders Vomiting	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	12.5% 1/8 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/6 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	12.5% 1/8 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/6 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.
Musculoskeletal and connective tissue disorders Neck pain	12.5% 1/8 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/6 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.
Nervous system disorders Headache	12.5% 1/8 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	50.0% 3/6 • Number of events 3 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.
Nervous system disorders Hepatic encephalopathy	0.00% 0/8 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	12.5% 1/8 • Number of events 1 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.	0.00% 0/6 • Up to 35 days All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
• Publication restrictions are in place

Restriction type: OTHER