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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6024-014 | Registry Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Efinopegdutide in Healthy-Matched Control Group | Experimental | Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efinopegdutide | Drug | Subcutaneous injection administered at a dose of 7 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami ( Site 0005) | Miami | Florida | 33014-3616 | United States | ||
| Advanced Pharma CR, LLC ( Site 0001) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Efinopegdutide in Healthy-Matched Control Group | Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Efinopegdutide in Participants With Severe Hepatic Impairment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | hr*μg/mL | 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 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2023 | Oct 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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|
Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.
| 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. | 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 |
| 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. | Up to 35 days |
| Miami |
| Florida |
| 33147 |
| United States |
| Genesis Clinical Research, LLC ( Site 0006) | Tampa | Florida | 33603 | United States |
| American Research Corporation ( Site 0002) | San Antonio | Texas | 78215 | United States |
Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
| BG002 | Efinopegdutide in Healthy-Matched Control Group | Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. |
| OG002 | Efinopegdutide in Healthy-Matched Control Group | Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
|
|
|
| Primary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | hr*μg/mL | 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 |
|
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose were used to determine the Cmax. | 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. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 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 |
|
|
|
|
| Primary | Time to Maximum Concentration (Tmax) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose were used to determine the Tmax of efinopegdutide. | 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. | Posted | Median | Full Range | hour | 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 |
|
|
|
| Primary | Apparent Terminal Half-life (t/12) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose were used to determine the t1/2. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | 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 |
|
|
|
| Primary | Apparent Total Clearance (CL/F) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose were used to determine the CL/F. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | 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 |
|
|
|
| Primary | Apparent Volume of Distribution (Vz/F) of Efinopegdutide | Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | 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 | 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. | All participants who received at least 1 dose of study treatment. | Posted | Number | Participants | Up to 35 days |
|
|
|
| Secondary | 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. | All participants who received at least 1 dose of study treatment. | Posted | Number | Participants | Up to 35 days |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 2 |
| 8 |
| EG001 | 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. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG002 | Efinopegdutide in Healthy-Matched Control Group | Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. | 0 | 6 | 0 | 6 | 4 | 6 |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
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.
| Geometric Mean Ratio |
| 0.93 |
| 2-Sided |
| 90 |
| 0.53 |
| 1.65 |
| Other |
| Geometric Mean Ratio |
| 0.85 |
| 2-Sided |
| 90 |
| 0.47 |
| 1.53 |
| Other |