A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 2

Conditions: Nonalcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic; Non-alcoholic Fatty Liver Disease; NAFLD; Nonalcoholic Steatohepatitis

Treatments: Drug: Semaglutide; Drug: Placebo; Drug: Efinopegdutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05877547

2022-502647-35-00 (Registry Identifier)

6024-013

jRCT2031230187 (Registry Identifier)

MK-6024-013 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
• No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
• Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)

Exclusion criteria

• History of liver disease other than NASH
• History or evidence of cirrhosis
• History of pancreatitis
• History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
• History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality
• Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 5 patient groups, including a placebo group

Efinopegdutide 4mg

Experimental group

Description:

Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks.

Treatment:

Drug: Efinopegdutide

Efinopegdutide 7mg

Experimental group

Description:

Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks.

Treatment:

Drug: Efinopegdutide

Efinopegdutide 10mg

Experimental group

Description:

Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks.

Treatment:

Drug: Efinopegdutide

Placebo

Placebo Comparator group

Description:

Placebo administered by SC injection once weekly for 52 weeks

Treatment:

Drug: Placebo

Semaglutide 2.4 mg

Active Comparator group

Description:

Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks.

Treatment:

Drug: Semaglutide