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RecruitingMetabolic Dysfunction-associated Steatohepatitis

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)

Eligible age

18–75 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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

Sponsor: GlaxoSmithKline

You may qualify if…

  • 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.

You may not qualify if…

  • 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.

Where it's recruiting

Florida

Miami

Source: ClinicalTrials.gov · NCT07701993 · last updated 2026-08-05

A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efi · TrialPath