A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3

Inclusion Criteria

• •1. Male or female between 18 and 75 years of age (inclusive).
• •2. BMI above 25.0 kg/m2
• •3. Biopsy confirmed NASH with histologic liver fibrosis stage 3 as defined by the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) scoring of liver fibrosis based on available historical biopsy report if the following are met:
• •i. Historical biopsy was obtained no more than 6 months (180 ± 5 days) prior to the first day of Screening. ii. No new therapeutic intervention for NASH of at least 2 or more weeks was made during the preceding 3-month (90-day) period (e.g., vitamin E ≥ 400 IU/day, pioglitazone, or incretins \[e.g., liraglutide, semaglutide\]). Subjects may be treated with vitamin E or pioglitazone as long as such subjects are maintained on a stable dose for 3 months prior to randomization, and the dose should be held constant during the trial.
• •4. Subjects without historical biopsy will be eligible for inclusion if their AGILE 3+ score using the FibroScan Diagnostic App is ≥0.53. The AGILE 3+ score is composed of: FibroScan fibrosis score, laboratory values (AST, ALT, Platelets), and clinical parameters (Age, Sex, Diabetes status) to calculate the AGILE 3+ score.
• •2. Subjects with symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection identified during the screening period.
• •3. At screening, subjects with uncontrolled hypertension (either treated or untreated) defined as a systolic blood pressure \>160mmHg or a diastolic blood pressure of \>110mmHG.
• •4. Subjects on either a non-selective beta blocker or an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) who are unwilling/unable to delay taking their normal dose the morning of HepQuant testing.
• •5. Subjects with transaminases \>5 x upper limit of normal (ULN).
• •6. Subjects with ALP \>2 x ULN.
• •7. Subjects with total serum bilirubin \>1.5 x ULN, unless the subject has Gilbert's Syndrome, in which case the subject can be enrolled provided the direct bilirubin is within 30% of the total bilirubin.
• •8. Subjects with a platelet count \<140,000/mm3.
• •9. Subjects with an INR ≥ 1.3 in the absence of anticoagulants.
• •10. Subjects with albumin \<3.5 g/dL.
• •11. Model for End-Stage Liver Disease (MELD) score \>12, unless due to an alternate etiology such as therapeutic anticoagulation or Gilbert's.
• •12. An estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] method).
• •13. Subjects with hemoglobin A1c (HbA1c) \>9.5%.
• •14. Other well documented causes of chronic liver disease according to standard diagnostic procedures.