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Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of efruxifermin in subjects with cirrhosis
THE PRIMARY OBJECTIVE IS TO EVALUATE THE EFFECT OF EFX COMPARED TO PLACEBO ON ALL-CAUSE MORTALITY ALL-CAUSE MORTALITY AND LIVER-RELATED CLINICAL OUTCOMES MEASURED BY TIME TO FIRST OCCURRENCE OF ANY OF THE PREDEFINED EVENTS IN SUBJECTS WITH COMPENSATED CIRRHOSIS DUE TO NASH/MASH. Y TO EVALUATE THE EFFECT OF EFX COMPARED TO PLACEBO ON FIBROSIS REGRESSION FIBROSIS REGRESSION WITHOUT NASH/MASH WORSENING IN SUBJECTS WITH NASH/MASH IN SUBJECTS WITH BIOPSY-PROVEN COMPENSATED CIRRHOSIS AT WEEK 96 (COHORT 1 ONLY). WEEK 96 (COHORT 1 ONLY).
Technical Summary
- PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH COMPENSATED CIRRHOSIS DUE TO STEATOHEPATITIS, NONALCOHOLIC STEATOHEPATITIS (NASH)/ASSOCIATED METABOLIC DYSFUNCTION, AND STEATOHEPATITIS ASSOCIATED WITH METABOLIC DYSFUNCTION (MASH).
- Code EudraCT: 2024-512895-36-00
- Protocol number: AK-US-001-0106
- Promoter: Akero Therapeutics, Inc
- Molecule/Drug: Efruxifermina
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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