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)

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

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

Conditions2

Interventions1

Locations9 sites

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Related trials

• A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage 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 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
• 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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