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

Completed · Phase 2

Conditions studied: Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT04944992

Run by

Merck Sharp & Dohme LLC

People needed

145

Starts

2021-08-04

Expected to finish

2022-10-19

Last updated by the study team

2023-11-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Sweet Hope Research Specialty, Inc ( Site 1902) — Hialeah, Florida, United States
• Floridian Clinical Research, LLC ( Site 1950) — Miami Lakes, Florida, United States
• Sensible Healthcare, LLC ( Site 1903) — Ocoee, Florida, United States
• Lucas Research, Inc ( Site 1930) — Morehead City, North Carolina, United States
• Texas Clinical Research Institute ( Site 1910) — Arlington, Texas, United States
• Baylor College of Medicine-Advanced Liver Therapies ( Site 1960) — Houston, Texas, United States
• American Research Corporation at Texas Liver Institute ( Site 1920) — San Antonio, Texas, United States
• Clinical Trials of Texas, Inc. ( Site 1906) — San Antonio, Texas, United States
• CIPREC-Laboratorio ( Site 0104) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Instituto de Investigaciones Clínicas Mar del Plata ( Site 0101) — Mar del Plata, Buenos Aires, Argentina
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0105) — Buenos Aires, Buenos Aires F.D., Argentina
• IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0107) — Buenos Aires, Argentina
• Westmead Hospital-Gastroenterology & Hepatology ( Site 0204) — Westmead, New South Wales, Australia
• Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 0201) — Bedford Park, South Australia, Australia
• Heritage Medical Research Clinic ( Site 0302) — Calgary, Alberta, Canada
• Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-ENDOCRINOLOGY-DIABETOLOGY ( Site 0401) — Dijon, Cote-d Or, France
• centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0402) — Pierre-Bénite, Rhone, France
• Rambam Health Care Campus-Liver disease unit ( Site 0704) — Haifa, Israel
• Carmel Hospital-Liver Unit ( Site 0705) — Haifa, Israel
• Shaare Zedek Medical Center-Liver Unit ( Site 0703) — Jerusalem, Israel
• Rabin Medical Center ( Site 0701) — Petah Tikva, Israel
• Sheba Medical Center-The Liver Diseases Center ( Site 0700) — Ramat Gan, Israel
• Sourasky Medical Center-Gastroenterology and Liver Disease ( Site 0702) — Tel Aviv, Israel
• Policlinico Umberto I ( Site 0801) — Rome, Lazio, Italy
• Catalina Research Institute, LLC ( Site 1939) — Montclair, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.