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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

NCTNCT04944992 (opens ClinicalTrials.gov in a new tab)Other id6024-001Other idMK-6024-001Other id2020-005136-30

Overview

Status
Completed
Phase
Phase 2
Enrollment
145 participants (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Open label (no masking)
Countries
16 countries

United States, Argentina, Australia, Canada, France, Israel, Italy, Mexico, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine

Start
4 Aug 2021
Primary completion
19 Oct 2022
Completion
19 Oct 2022
First posted
30 Jun 2021
Last update posted
15 Nov 2023
Conditions
Nonalcoholic Fatty Liver Disease · Nonalcoholic Steatohepatitis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 2

    A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

    NCT04944992

    4 Aug 2021 to 19 Oct 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

Interventions

  • Efinopegdutide 20 mg/mLDrug
  • Semaglutide 1.34 mg/mLDrug

Arms2

  • Experimental

    Efinopegdutide

    Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.

  • Active comparator

    Semaglutide

    Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks

    Time frame · Baseline and up to ~24 Weeks

    Registry description

    LFC was measured with liver images taken by MRI-PDFF and analyzed by BICR. Relative Reduction from Baseline to Week 24 = (Baseline - Week 24) / Baseline x 100%. Mean relative reduction from baseline in liver fat content is presented.

  2. Percentage of Participants Who Experienced an Adverse Event (AE)

    Time frame · Up to ~29 weeks

    Registry description

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 study intervention. The percentage of participants who experienced an adverse event is presented.

  3. Percentage of Participants Who Discontinued Study Intervention Due to an AE

    Time frame · Up to ~24 weeks

    Registry description

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 study intervention. The percentage of participants who discontinued study intervention due to adverse event is presented.

Secondary outcomes(8)
  1. Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks

    Time frame · Baseline and up to ~24 Weeks

    Registry description

    LFC was measured by liver images taken by MRI-PDFF and analyzed by BICR. The absolute reduction from baseline to Week 24 = Baseline - Week 24. The mean absolute reduction from baseline in LFC after 24 weeks of treatment is presented.

  2. Mean Percent Change From Baseline in Body Weight After 24 Weeks

    Time frame · Baseline and up to ~24 weeks

    Registry description

    Body weight in kilograms was measured using a standardized, digital scale. The mean percent change from baseline in body weight after 24 weeks is presented.

  3. Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks

    Time frame · Baseline and up to ~24 weeks

    Registry description

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in total cholesterol. The mean percent change in total cholesterol is presented.

  4. Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks

    Time frame · Baseline and up to ~24 weeks

    Registry description

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in non-HDL-C. The mean percent change in non-HDL-C is presented.

  5. Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks

    Time frame · Baseline and up to ~24 weeks

    Registry description

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in HDL-C. Mean percent change in HDL-C is presented.

  6. Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks

    Time frame · Baseline and up to ~24 weeks

    Registry description

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in LDL-C. The mean percent change in LDL-C is presented.

  7. Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks

    Time frame · Baseline and up to ~24 weeks

    Registry description

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in triglycerides. The mean percent change in triglycerides is presented.

  8. Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks

    Time frame · Baseline and up to ~24 weeks

    Registry description

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in apoB. The mean percent change in apoB is presented.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline and up to ~24 Weeks

Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks

GroupValue (Percent Reduction)
Efinopegdutide72.7
Semaglutide42.3
Primary outcomeNumber· Up to ~29 weeks

Percentage of Participants Who Experienced an Adverse Event (AE)

GroupValue (Percentage of Participants)
Efinopegdutide88.9
Semaglutide72.6
Primary outcomeNumber· Up to ~24 weeks

Percentage of Participants Who Discontinued Study Intervention Due to an AE

GroupValue (Percentage of Participants)
Efinopegdutide5.6
Semaglutide0
Secondary and other outcome results(5)
Secondary outcomeLeast squares mean· Baseline and up to ~24 Weeks

Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks

GroupValue (Percentage of liver fat)
Efinopegdutide14.9
Semaglutide8.8
Secondary outcomeLeast squares mean· Baseline and up to ~24 weeks

Mean Percent Change From Baseline in Body Weight After 24 Weeks

GroupValue (Percent Change)
Efinopegdutide-8.5
Semaglutide-7.1
Secondary outcomeLeast squares mean· Baseline and up to ~24 weeks

Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks

GroupValue (Percent Change)
Efinopegdutide-15.2
Semaglutide-8.0
Secondary outcomeLeast squares mean· Baseline and up to ~24 weeks

Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks

GroupValue (Percent Change)
Efinopegdutide-16.8
Semaglutide-11.0
Secondary outcomeLeast squares mean· Baseline and up to ~24 weeks

Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks

GroupValue (Percent Change)
Efinopegdutide-8.1
Semaglutide3.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
EfinopegdutideEfinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.0 / 721 / 7257 / 72
SemaglutideSemaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.0 / 731 / 7344 / 73

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

4 results

A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease.

Romero-Gómez et al. 2023Journal of hepatologycited by 186

PMID 37355043DOI 10.1016/j.jhep.2023.05.013PUB-37355043

Full text at the publisher4 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * LFC ≥10% as assessed by MRI-PDFF at time of screening. * Body Mass Index (BMI) ≥25 kg/m² and ≤50 kg/m² at time of screening. * Stable weight (based on self-reporting) defined as ≤5% gain or loss of body weight for at least 3 months before screening visit. * No history of Type 2 Diabetes Mellitus (T2DM) OR history of T2DM with an Glycated Hemoglobin (A1C) ≤8.5% at screening AND controlled by diet or a stable dose of metformin for the 3 months before screening. * A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 5 weeks after the last dose of study intervention. * Participants in Taiwan are eligible between the ages of 20 to 70 years of age (inclusive). * Participants in South Korea are eligible between the ages of 19 to 70 years of age (inclusive). Exclusion Criteria: * History of Type 1 Diabetes Mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatitis or pancreatectomy. * Ongoing, inadequately controlled hypothyroidism or hyperthyroidism. * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasm type-2 syndrome. * Recent event (within 6 months prior to screening) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack. * History or evidence of chronic liver disease other than NAFLD or Non-Alcoholic SteatoHepatitis (NASH). * Known history of cirrhosis. * History of acute or chronic pancreatitis. * History of a bariatric surgical procedure or a known clinically significant gastric emptying abnormality. * History of malignancy ≤5 years prior to screening, except for skin cancer or cervical cancer. * Clinically active hematologic disorder. * Diagnosis of human immunodeficiency virus (HIV). * Surgery requiring general anesthesia within 3 months before screening visit. * History of organ transplantation, except for corneal transplant. * Active diabetic proliferative retinopathy or a history of maculopathy. * Untreated obstructive sleep apnea. * History of treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist within 6 months before screening. * History of treatment with thiazolidinediones (ie, pioglitazone, rosiglitazone) within 6 months before screening. * Previous use (within 3 months before screening) or current use of prescription weight-management medications or over-the-counter weight-loss medications or therapies. * Treatment with systemic corticosteroid medication within 3 months before screening. * Current treatment with anticoagulants (eg, warfarin, heparin). * Inability to have an MRI-PDFF performed due to either severe claustrophobia, metallic implant that prevents MRI-PDFF examination, or any other contraindication to MRI-PDFF examination. * Previous or current history of significant alcohol consumption (average of 7 standard drinks per week in females or 14 standard drinks per week in males) for a period of more than 3 consecutive months in the 24 months before screening.

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