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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling
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

300 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

300 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

Trial contacts and locations

166

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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