A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH

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. International normalized ratio (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 m2.
• •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 and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension.
• •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 conditions or procedures within 6 months prior to the baseline visit (V1):
• •1. Myocardial infarction
• •2. Cardiac revascularization surgery
• •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\. Use of a nonpermitted concomitant medication within 30 days or 5 half-lives prior to screening.