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Clinical Trials in Japan / NCT07704892
Recruiting Phase 3

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)

NCT07704892 · tracked via the Priya Life Science Japan tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2026-07-22
Last updated
2026-09-30

Condition(s) studied

Metabolic Dysfunction-associated Steatohepatitis

Investigational drug(s) / intervention(s)

Efimosfermin alfa →Placebo

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

Placebo: Placebo (subcutaneous injection) will be administered.

Study 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

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

Primary outcome measure(s)

  • Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH — At Week 96
    Participants experiencing improvement in liver fibrosis of \>=1 stage (based on MASH Clinical Research Network (CRN) fibrosis score) and no worsening of MASH (defined as no increase in nonalcoholic fatty liver disease activity score for ballooning, inflammation, or steatosis). MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.

Trial sites (20)

FacilityCityRegionStatus
GSK Investigational Site Little Rock Arkansas Recruiting
GSK Investigational Site Folsom California Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Ocala Florida Recruiting
GSK Investigational Site St Louis Missouri Recruiting
GSK Investigational Site New York New York Recruiting
GSK Investigational Site Morehead City North Carolina Recruiting
GSK Investigational Site Springboro Ohio Recruiting
GSK Investigational Site Westlake Ohio Recruiting
GSK Investigational Site Arlington Texas Recruiting
GSK Investigational Site Austin Texas Recruiting
GSK Investigational Site Bellaire Texas Recruiting
GSK Investigational Site Dallas Texas Recruiting
GSK Investigational Site Houston Texas Recruiting
GSK Investigational Site Humble Texas Recruiting
GSK Investigational Site San Antonio Texas Recruiting
GSK Investigational Site San Antonio Texas Recruiting
GSK Investigational Site Ōgaki Gifu Recruiting
GSK Investigational Site Kawasaki-shi Japan Recruiting

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Other trials for the same condition

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) Recruiting
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 NCT07704892 on ClinicalTrials.gov ↗ ← All trials in Japan