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Clinical Trials in the USA / NCT07701993
Recruiting Phase 3

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)

NCT07701993 · tracked via the Priya Life Science USA tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2026-07-22
Last updated
2026-09-18

Condition(s) studied

Metabolic Dysfunction-associated Steatohepatitis

Investigational drug(s) / intervention(s)

Efimosfermin alfaPlacebo

Efimosfermin alfa: Efimosfermin alfa (subcutaneous injection) will be administered.

Placebo: Placebo (subcutaneous injection) will be administered.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Dallas Texas Recruiting
GSK Investigational Site Humble Texas Recruiting
GSK Investigational Site San Antonio Texas Recruiting
GSK Investigational Site Ōgaki Gifu Recruiting
GSK Investigational Site Kawasaki-shi Japan Recruiting

More GlaxoSmithKline trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07701993 on ClinicalTrials.gov ↗ ← All trials in the USA