A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3… (NCT06594523) | Clinical Trial Compass
WithdrawnPhase 3
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
Stopped: Business decision
0Started 2025-03
Plain-language summary
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression without the worsening of steatohepatitis.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Willing and able to participate in the study and provide written informed consent.
✓. Adults between 18 and 75 years of age.
✓. Body mass index (BMI) ≥23 kg/m\^2 for Asian patients and ≥25 kg/m\^2 for patients of other races.
✓. Presence of metabolic risk factor(s), as follows:
✓. T2DM.
✓. 2 out of 4 of the following:
✓. For patients with T2DM:
✓. Noncirrhotic, biopsy-proven MASH with:
Exclusion criteria
✕. Previous intake of an approved MASH medication.
✕. Exclusionary laboratory values:
✕. ALT and/or AST \>5 × ULN.
✕. ALP ≥2 × ULN.
✕. Total serum bilirubin concentration \>1.3 mg/dL.
✕. Serum albumin concentration \<3.5 g/dL.
✕. INR \>1.3 except for patients receiving anticoagulant treatment.