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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 69
- 主要终点
- Percentage of Participants Who Discontinued Study Intervention Due to an AE
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Efinopegdutide 20 mg/mL (Drug)
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.
干预措施: Semaglutide 1.34 mg/mL (Drug)
结局指标
主要结局
Percentage of Participants Who Discontinued Study Intervention Due to an AE
时间窗: 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.
Percentage of Participants Who Experienced an Adverse Event (AE)
时间窗: 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.
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
时间窗: 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.
次要结局
- Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks(Baseline and up to ~24 Weeks)
- Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks(Baseline and up to ~24 weeks)
- Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks(Baseline and up to ~24 weeks)
- Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks(Baseline and up to ~24 weeks)
- Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks(Baseline and up to ~24 weeks)
- Mean Percent Change From Baseline in Body Weight After 24 Weeks(Baseline and up to ~24 weeks)
- Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks(Baseline and up to ~24 weeks)
- Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks(Baseline and up to ~24 weeks)