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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)

RecruitingPhase 3Ages 18 Years - 75 YearsAllGlaxoSmithKline
NCT07704892 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Efimosfermin alfa
  • Placebo
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Where

20 sites
GSK Investigational Site
Little Rock, United States
GSK Investigational Site
Folsom, United States
GSK Investigational Site
Miami, United States
GSK Investigational Site
Miami, United States
GSK Investigational Site
Ocala, United States
GSK Investigational Site
St Louis, United States
GSK Investigational Site
New York, United States
GSK Investigational Site
Morehead City, United States

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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