A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hepion Pharmaceuticals, Inc.

Criteria

Key Inclusion Criteria:

• Male or female between 18 and 75 years of age (inclusive).

• Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.

• Presumed F2/F3 NASH to include: AST >20 IU/L, Pro-C3 >15.5 ng/mL, enhanced liver fibrosis (ELF) score >9.8, and FibroScan >8.5 kPa values.

Key Exclusion Criteria:

• Pregnant or breastfeeding or planning to become pregnant during the study period.

• Known allergy to CRV431, cyclosporine, or any of their inactive ingredients.

• Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus antibodies (HIVAb).

• Well documented causes of chronic liver disease according to standard diagnostic procedures to include any history or presence of decompensated cirrhosis.

• Subjects with a platelet count <150,000/mL.

• Subjects with hemoglobin A1c(HbA1c) >9.5%.

• Weight loss of more than 5% within 3 months prior to randomization.

• Subjects with a blood pressure to include a systolic pressure >150 or a diastolic pressure >90.

• At Screening, an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 mL (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] method) and/or a Kidney Disease Improving Global Outcomes (KDIGO) category of >G2.

• Subjects with a history of organ transplantation. Corneal transplantation will be allowed.