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)

Summary

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

Eligibility

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.

Conditions2

Interventions1

Locations5 sites

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• A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH — GlaxoSmithKline
• 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
• A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH — GlaxoSmithKline
• A Study of Efimosfermin Alfa in Adults With Hepatic Impairment — GlaxoSmithKline
• A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD) — GlaxoSmithKline

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