A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis

Exclusion Criteria

• •1. Previous intake of an approved MASH medication.
• •2. Exclusionary laboratory values:
• •1. ALT and/or AST \>5 × ULN.
• •2. ALP ≥2 × ULN.
• •3. Total serum bilirubin concentration \>1.3 mg/dL.
• •4. Serum albumin concentration \<3.5 g/dL.
• •5. INR \>1.3 except for patients receiving anticoagulant treatment.
• •6. Platelet count \<140,000/μL.
• •7. Fasting TG level ≥500 mg/dL.
• •8. eGFR \<45 mL/min/1.73 m\^2.
• •3. History of excessive alcohol intake for a period of more than 3 consecutive months within 1 year prior to screening.
• •4. Presence of cirrhosis on liver histology according to the assessment of the central reader.
• •5. Current or historical clinically evident hepatic decompensation.
• •6. Evidence of another form of active liver disease.
• •7. Positive serologic evidence of current infectious liver disease.
• •8. MELD score ≥12.
• •9. Planned or history of liver transplantation.
• •10. Prior or planned bariatric surgery.
• •11. Gain or loss of \>5% of body weight in the 3 months or \>10% of body weight in the 6 months prior to screening, qualifying liver biopsy, and the baseline visit (V1).
• •12. Any of the following within 6 months prior to the baseline visit (V1):
• •1. Myocardial infarction.
• •2. CABG/PTCA.
• •3. Unstable angina.
• •4. Transient ischemic attack, stroke, or cerebrovascular disease.
• •13. Unstable or undiagnosed arrhythmias.
• •14. Uncontrolled high BP.
• •15. Malignancy with a complete remission date within 5 years prior to the baseline visit (V1).
• •16. Any current or history of hepatocellular carcinoma.
• •17. Diabetes other than T2DM.
• •18. Uncontrolled hypothyroidism.
• •19. Any other known serious disease or other disease which in the Investigator's opinion would exclude the patient from participating in the study.
• •20. Previous intake of an approved MASH medication, unless there is at least a 6-month wash-out period between the last date of intake of the approved MASH medication and date of screening.
• •21. Use of a nonpermitted concomitant medication within 30 days or 5 half-lives prior to the qualifying liver biopsy and screening.