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NCT07701993
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)
Conditions: Metabolic Dysfunction-associated Steatohepatitis
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1740
Sponsor: GlaxoSmithKline
Location: GSK Investigational Site Miami Florida
Summary
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07701993). StuddyBuddy aggregates publicly available trial information.