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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6024-016 | Other Identifier | MSD |
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This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and tolerability of the different regimens of efinopegdutide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efinopegdutide Q1W 10 mg | Active Comparator | Participants will receive efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
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| Efinopegdutide Q2W 10 mg | Experimental | Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
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| Efinopegdutide Q2W 15 mg | Experimental | Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efinopegdutide | Drug | SC injections in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg in all arms and 15 mg in the Efinopegdutide Q2W 15 mg arm |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Relative Reduction From Baseline in Liver Fat Content at Week 28 | Liver fat content (LFC) was measured with liver images taken by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Least Squares (LS) Mean relative reduction from baseline in LFC is presented. | Baseline and Week 28 |
| Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE is presented. | Up to Week 32 |
| Percentage of Participants Who Discontinued Study Intervention Due to an AE | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinued study intervention due to an AE is presented. | Up to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Body Weight at Week 28 | Body weight in kilograms was measured using a standardized, digital scale. Mean percent change in body weight from Baseline to Week 28 = (Week 28 - Baseline) / Baseline x 100%. The LS mean percent change from baseline in body weight at 28 weeks is presented. | Baseline and Week 28 |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp and Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0 | Chandler | Arizona | 85224 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Participants were randomized to 1 of 3 efinopegdutide regimen groups: 10 mg once weekly (Q1W), 10 mg every 2 weeks (Q2W), or 15 mg Q2W.
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| ID | Title | Description |
|---|---|---|
| FG000 | Efinopegdutide Q1W 10 mg | Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
| FG001 | Efinopegdutide Q2W 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Nov 4, 2024 |
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| The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0224) | Peoria | Arizona | 85381 | United States |
| Arizona Liver Health ( Site 0211) | Tucson | Arizona | 85712 | United States |
| Del Sol Research Management, LLC ( Site 0209) | Tucson | Arizona | 85715 | United States |
| Om Research LLC ( Site 0207) | Camarillo | California | 93012 | United States |
| Gastroenterology and Liver Institute ( Site 0263) | Escondido | California | 92025 | United States |
| Velocity Clinical Research, Gardena ( Site 0235) | Gardena | California | 90247 | United States |
| Velocity Clinical Research, Huntington Park ( Site 0210) | Huntington Park | California | 90255 | United States |
| California Liver Research Institute ( Site 0216) | Pasadena | California | 91105 | United States |
| Acclaim Clinical Research ( Site 0241) | San Diego | California | 92120 | United States |
| Velocity Clinical Research, Santa Ana ( Site 0250) | Santa Ana | California | 92704 | United States |
| Velocity Clinical Research, Panorama City ( Site 0228) | Van Nuys | California | 91405 | United States |
| Excel Medical Clinical Trials ( Site 0268) | Boca Raton | Florida | 33434 | United States |
| AGA Clinical Trials ( Site 0274) | Hialeah | Florida | 33012 | United States |
| Neoclinical Research ( Site 0275) | Hialeah | Florida | 33016 | United States |
| Homestead Associates in Research, Inc. ( Site 0243) | Homestead | Florida | 33033 | United States |
| Floridian Clinical Research, LLC ( Site 0208) | Miami Lakes | Florida | 33016 | United States |
| Southeast Clinical Research Center ( Site 0223) | Dalton | Georgia | 30720 | United States |
| Velocity Clinical Research Rockville ( Site 0245) | Rockville | Maryland | 20854 | United States |
| The Machuca Foundation ( Site 0218) | Las Vegas | Nevada | 89101 | United States |
| Excel Clinical Research, LLC ( Site 0200) | Las Vegas | Nevada | 89109 | United States |
| Basil Clinical ( Site 0246) | Inwood | New York | 11096 | United States |
| Lucas Research, Inc ( Site 0204) | Morehead City | North Carolina | 28557 | United States |
| Texas Clinical Research Institute ( Site 0230) | Arlington | Texas | 76012 | United States |
| Pinnacle Clinical Research ( Site 0203) | Austin | Texas | 78757 | United States |
| Velocity Clinical Research, Austin ( Site 0201) | Austin | Texas | 78759 | United States |
| Pinnacle Clinical Research-Corpus Christi ( Site 0267) | Corpus Christi | Texas | 78404 | United States |
| Zenos Clinical Research ( Site 0240) | Dallas | Texas | 75230 | United States |
| South Texas Research Institute ( Site 0226) | Edinburg | Texas | 78539 | United States |
| Houston Research Institute ( Site 0221) | Houston | Texas | 77079 | United States |
| American Research Corporation ( Site 0234) | San Antonio | Texas | 78215 | United States |
| Clinical Trials of Texas, LLC-Clinical Research ( Site 0252) | San Antonio | Texas | 78229 | United States |
| Pinnacle Clinical Research-Clinical Research Coordination ( Site 0229) | San Antonio | Texas | 78229 | United States |
| Impact Research Institute ( Site 0227) | Waco | Texas | 76710 | United States |
| Olympus Family Medicine/CCT Research ( Site 0266) | Holladay | Utah | 84117 | United States |
| South Ogden Family Medicine/ CCT Research ( Site 0255) | South Ogden | Utah | 84405 | United States |
| San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0104) | Caguas | 00726 | Puerto Rico |
| Klinical Investigations Group-Clinical Research ( Site 0100) | San Juan | 00909 | Puerto Rico |
| Pan American Center for Oncology Trials - Ciudadela ( Site 0101) | San Juan | 00909 | Puerto Rico |
Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
| FG002 | Efinopegdutide Q2W 15 mg | Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Efinopegdutide Q1W 10 mg | Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
| BG001 | Efinopegdutide Q2W 10 mg | Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
| BG002 | Efinopegdutide Q2W 15 mg | Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Body weight of participants | Mean | Standard Deviation | kg |
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| 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 | Mean Relative Reduction From Baseline in Liver Fat Content at Week 28 | Liver fat content (LFC) was measured with liver images taken by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Least Squares (LS) Mean relative reduction from baseline in LFC is presented. | All randomized participants who received at least one dose of study intervention and have baseline data for the analysis. | Posted | Least Squares Mean | 90% Confidence Interval | Percent Reduction | Baseline and Week 28 |
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| Primary | Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE is presented. | All randomized participants who received at least one dose of study intervention. | Posted | Number | Percentage of participants | Up to Week 32 |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Discontinued Study Intervention Due to an AE | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinued study intervention due to an AE is presented. | All randomized participants who received at least one dose of study intervention. | Posted | Number | Percentage of participants | Up to Week 28 |
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| Secondary | Mean Percent Change From Baseline in Body Weight at Week 28 | Body weight in kilograms was measured using a standardized, digital scale. Mean percent change in body weight from Baseline to Week 28 = (Week 28 - Baseline) / Baseline x 100%. The LS mean percent change from baseline in body weight at 28 weeks is presented. | All randomized participants who received at least one dose of study intervention and have baseline data for the analysis. | Posted | Least Squares Mean | 90% Confidence Interval | Percent Change | Baseline and Week 28 |
|
Up to Week 32
All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
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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 Q1W 10 mg | Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. | 0 | 42 | 3 | 42 | 30 | 42 |
| EG001 | Efinopegdutide Q2W 10 mg | Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. | 0 | 40 | 2 | 39 | 27 | 39 |
| EG002 | Efinopegdutide Q2W 15 mg | Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks. | 0 | 42 | 4 | 42 | 33 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Lumbar radiculopathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
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The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| May 5, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D004066 | Digestive System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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