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Completed

NCT Number: NCT04944992

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CIPREC-Laboratorio ( Site 0104), Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Efinopegdutide 20 mg/mL

Drug

Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg

Other names: MK-6024, HM12525A, JNJ-64565111

Semaglutide 1.34 mg/mL

Drug

Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg

Other names: Ozempic®

Primary outcomes

  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

    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

    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

    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

  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

    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

    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

    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

    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

    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

    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

    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

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2021
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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