A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH

Phase 2RecruitingNCT06920043

Boston Pharmaceuticals42 enrolled

Overview

The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Metabolic Dysfunction-Associated Steatohepatitis

Interventions

EfimosferminDRUG

Efimosfermin will be administered as a subcutaneous injection.

PlaceboDRUG

Placebo will be administered as a subcutaneous injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ability to understand and sign a written informed consent form (ICF) * Age 18 through 75 years at enrollment * History or presence of 2 or more of the 5 components of metabolic syndrome * Liver biopsy confirmation of MASH consistent with stage F4 fibrosis * Other inclusion criteria may apply. Exclusion Criteria: * Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease * History of type 1 diabetes * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN) * Other exclusion criteria may apply.

Locations (35)

Outcomes

Primary Outcomes

Number of participants with treatment emergent adverse events (TEAEs)

To assess the effects of efimosfermin on safety and tolerability.

Time frame: From Day 1 to 100 weeks