A Phase 3, double-blind, randomized, placebo controlled, 2-arm study to investigate the safety and efficacy of efimosfermin alfa injection in adult participants with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (NEBULA-1)

未提供0 个研究点目标入组 103 人开始时间: 待定

适应症

试验速览

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•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 metablic syndrome.

•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 ALT or AST >= 5 times upper limit normal.
•Participants with current or history of excessive alcohol intake.

发起方

未提供