CENTAUR (Efficacy and Safety Study of Cenicriviroc for the Treatment of NASH in Adult Subjects With Liver Fibrosis) looked at histologic improvement in NAFLD over the course of 2 years. Patients were randomized into either the cenicriviroc 150-mg group (group A) or two placebo groups (groups B and C) for the first year of the study. In the second year of the study patients in placebo group B started to receive 150 mg cenicriviroc and group C remained as the placebo until the end of year 2. NAFLD activity scores were similar between placebo and cenicriviroc. But, fibrosis outcomes were met at a much higher rate in the cenicriviroc group, compared with those seen with placebo (20% vs. 10%, respectively; P = 0.02).
Based on these findings, AURORA (Phase 3 Study for the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adults With NASH) is now evaluating the safety and efficacy of cenicriviroc in the treatment of liver fibrosis in adults with NASH.
Finally, there is selonsertib, an ASK1 inhibitor. A phase 2 trial showed that it had the potential to induce stage reduction in fibrosis at an 18-mg dose.
Now there are two phase 3 studies, STELLAR 3 and STELLAR 4, evaluating the effects of selonsertib in adults with NASH and NASH with compensated cirrhosis.