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NCT07701993PHASE3Recruiting

A Pivotal Clinical Study to Investigate the 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

8/24/2033

Summary

This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: * Participants aged between 18 and 75 years at enrollment. * Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments. * Participants with history or presence of at least two components of metabolic syndrome. 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 complications. * Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening. * Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss. * Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5 times upper limit normal (ULN). * Participants with 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

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

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