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

Ведущий спонсор: Merck Sharp & Dohme Corp.

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.

• Nonalcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Тип вмешательства: Drug

Название вмешательства: Efinopegdutide 20 mg/mL

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

Этикетка Arm Group: Efinopegdutide

Тип вмешательства: Drug

Название вмешательства: Semaglutide 1.34 mg/mL

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

Этикетка Arm Group: Semaglutide

Другое имя: Ozempic®

Критерии:

Inclusion Criteria: - Liver Fat Content (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 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 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.

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

70 Years

Здоровые волонтеры:

No

Фамилия: Toll Free Number

Телефон: 1-888-577-8839

Argentina

Australia

Canada

France

Israel

Italy

Korea, Republic of

Mexico

New Zealand

Poland

Russian Federation

Spain

Taiwan

Turkey

Ukraine

United States

2022-01-01

Тип: Sponsor

• Liver Diseases
• Fatty Liver
• Non-alcoholic Fatty Liver Disease

Метка: Efinopegdutide

Тип: Experimental

Описание: 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.

Метка: Semaglutide

Тип: Active Comparator

Описание: 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.

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: None (Open Label)