A Phase 2a Study of Efinopegdutide in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis

Phase 1

• Conditions: Metabolic Dysfunction-Associated Steatohepatitis; MedDRA version: 24.1Level: PTClassification code: 10053219Term: Non-alcoholic steatohepatitis Class: 100000004871; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2024-510923-20-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-16
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Has a diagnosis of compensated cirrhosis secondary to metabolic dysfunction-associated steatohepatitis (MASH) based on histology (nonalcoholic steatohepatitis Clinical Research Network [NASH CRN] criteria) or non-histological criteria based on protocol specified serum and imaging biomarkers., Has no history of type 2 diabetes mellitus (T2DM) or has a history of T2DM with a glycated hemoglobin (A1C) =9% and the T2DM is controlled by diet or stable doses of antihyperglycemic agents (AHAs)., Is of any sex/gender, from 18 years to 80 years of age inclusive., A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and Is either not a participant/participants of childbearing potential (POCBP) or is a POCBP and the following applies: uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 5 weeks after the last dose of study intervention, their medical history, menstrual history, and recent sexual activity have been reviewed by the investigator.

Exclusion Criteria

Has a history or evidence of chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD) or MASH., Has human immunodeficiency virus (HIV), as assessed by medical history or by current use of HIV antiretroviral therapy., Has hyperthyroidism or inadequately controlled hypothyroidism., Has a history of glucagonoma., Has a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2., Has significant systemic or major illnesses, including recent (=6 months before Visit 1a/Screening) onset of events of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack., Has a history of pathologic, symptomatic, or sustained tachyarrhythmia., Has a history of malignancy =5 years before Visit 1a/Screening, except for squamous or basal cell carcinomas of the skin and any in situ carcinomas, excluding in situ carcinoma of the bladder., Has undergone a major surgery (e.g, requiring general anesthesia) =3 months before Visit 1a/Screening, or has not fully recovered from surgery, or has major surgery planned during the participation of the current study., Has a history of organ transplantation, except for corneal transplant., Has received blood products =2 months before Visit 1a/Screening, and/or donated blood products =1 month before Visit 1a/Screening, and/or plans to donate blood products throughout the duration of the study., Has history of decompensated liver disease., Has a current diagnosis of end-stage renal disease and is receiving dialysis., Has known allergies, hypersensitivity, contraindication, or intolerance to the active ingredients and/or excipients of efinopegdutide., Has been treated with any protocol prohibited agents., Has previous or current use of prescription weight-management medications., Has been treated with pharmacologic doses of systemic corticosteroid medication., Is currently on treatment with an antihypertensive therapy that is not a stable dose for at least 3 months before Visit 1a/Screening., Is currently on treatment with an antihyperlipidemic therapy that is not a stable dose for at least 3 months before Visit 1a/Screening and through Visit 3/Randomization, Is currently participating in or has participated in an interventional clinical study and received an investigational compound or used an investigational device =3 months before participating in this study., Has a clinically significant electrocardiogram (ECG) abnormality that requires further diagnostic evaluation or intervention., Has developed a new medical condition, experienced a change in the status of an existing medical condition, developed a laboratory abnormality, or required a new treatment or medication during the Screening period that satisfies any of the study exclusion criteria., Has a baseline model for end-stage liver disease – sodium (MELD-Na) score =12 at Visit 1a/Screening, Has a previous or current history of significant alcohol consumption for a period of more than 3 consecutive months within the 24 months before Visit 1a/Screening or has an inability to reliably quantify alcohol consumption., Has a recent history (defined as =3 years) of drug abuse or is a current user of recreational or illicit drugs (per local regulations) at the time of Visit 1a/Screening., Has (or caregiver has) limitations that would prevent administration of the study intervention via injection, after receiving ins

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified