ASCEND-NASH: A PHASE 2B, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CRV431 IN ADULT SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS AND ADVANCED LIVER FIBROSIS
Nonalcoholic fatty liver disease (NAFLD) and its more severe form, nonalcoholic steatohepatitis (NASH) are significant health burdens and are on the rise across the globe. Nonalcoholic fatty liver disease is characterized by fat accumulation in the liver and often is associated with obesity, insulin resistance, diabetes mellitus, dyslipidemia, hypertension, and other aspects of metabolic syndrome. Nonalcoholic steatohepatitis shares these characteristics but additionally is characterized by liver inflammation, hepatocyte necrosis and potentially fibrosis, which places patients at increased risk of developing cirrhosis and liver cancer. There are currently no USA Food and Drug Administration (FDA) approved medications specifically for the treatment of NAFLD or NASH, but many drug candidates are in various stages of clinical development. Rencofilstat is being developed for once daily (QD) oral administration for the treatment of NASH. This is a randomized, double -blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis. This study consists of 3 phases: (i) Screening and Randomization; (ii) treatment; and (iii) follow up. Subjects will need to visit the study clinic 10 times within 15 months. Laboratory evaluations will be completed at every visit. Liver biopsy is required for participation in this trial.
Participants will be required to make 10 in person visits. Blood will be drawn at all visits. Participants will be required to take study meds as directed.
able to consent
Human Immunodeficiency Virus
hepatitis B and C virus