Intercept announced findings from the CONTROL study that evaluated the lipid metabolic effects of obeticholic acid (OCA) and statin therapy in patients with nonalcoholic steatohepatitis (NASH) with fibrosis or cirrhosis. 

The 16-week, double-blind, placebo-controlled, dose-ranging prospective study (n=84), enrolled NASH patients with fibrosis and compensated cirrhosis, is followed by the currently ongoing 2-year long-term safety extension (LTSE) open-label phase. Changes in lipid levels were measured every 4 weeks over the double-blind phase. 

Statin-naive or washout patients were randomized to either OCA 5mg, OCA 10mg, OCA 25mg or placebo. At Week 4, atorvastatin 10mg was added for all patients and were uptitrated to atorvastatin 20mg at Week 8. Then at Week 12, further titration to atorvastatin 40mg was allowed at the discretion of investigators. 

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The primary measure was the comparison of treatment differences within each group vs. baseline. Mean low-density lipoprotein (LDL) rose in each of the OCA treatment groups while the placebo group remained relatively unchanged. Adding atorvastatin 10mg quickly reduced mean LDL to below baseline levels for all OCA treatment arms at Week 8 (first time point) and this effect lasted through Week 16. 

The mean LDL change from baseline to Week 16 were as follows: placebo: -48 mg/dL, OCA 5mg: -40mg/dL, OCA 10mg: -40mg/dL, and OCA 25mg: -45mg/dL. The most common adverse effect in OCA-treated patients was mild to moderate pruritus. 

David Shapiro, MD, Chief Medical Officer of Intercept, added, “In CONTROL, we have shown that statin therapy can have an important role in managing LDL when co-administered with OCA in NASH patients with fibrosis and cirrhosis.”

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