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NCT07704892PHASE3Recruiting

A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)

GlaxoSmithKline

Start Date

7/22/2026

Completion Date

12/8/2033

Summary

This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: * Participants aged between 18 and 75 years at enrolment. * Participants with history or presence of at least two components of metabolic syndrome. * Liver biopsy consistent with cirrhosis (fibrosis stage 4). Exclusion Criteria: * Participants with other chronic liver diseases. * Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma. * Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications. * History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening. * A recent history or planned surgical procedures or medications intended to produce significant weight loss. * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>= 5 times upper limit normal (ULN). * Current or history of excessive alcohol intake

Interventions

DRUG

Efimosfermin alfa

DRUG

Placebo

Interested in This Trial?

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Conditions

Metabolic Dysfunction-associated Steatohepatitis

Locations

GSK Investigational Site

Little Rock, Arkansas 72211

United States

GSK Investigational Site

Folsom, California 95630

United States

GSK Investigational Site

Miami, Florida 33135-4661

United States

GSK Investigational Site

Miami, Florida 33155

United States

GSK Investigational Site

Ocala, Florida 34471

United States

GSK Investigational Site

St Louis, Missouri 63141

United States

GSK Investigational Site

New York, New York 10036-4103

United States

GSK Investigational Site

Morehead City, North Carolina 28557

United States

GSK Investigational Site

Springboro, Ohio 45066

United States

GSK Investigational Site

Westlake, Ohio 44145-1493

United States

GSK Investigational Site

Arlington, Texas 76012

United States

GSK Investigational Site

Austin, Texas 78745-5675

United States

GSK Investigational Site

Bellaire, Texas 77401

United States

GSK Investigational Site

Dallas, Texas 75243-1921

United States

GSK Investigational Site

Houston, Texas 77058

United States

GSK Investigational Site

Humble, Texas 77346

United States

GSK Investigational Site

San Antonio, Texas 78209

United States

GSK Investigational Site

San Antonio, Texas 78215

United States

GSK Investigational Site

Ōgaki, Gifu 503-8502

Japan

GSK Investigational Site

Kawasaki-shi, 215-0026

Japan