Intercept initiates CONTROL trial for treatment of NASH

Intercept Pharmaceuticals announced initiation of its CONTROL study, a phase 2 clinical trial that will evaluate the effect of obeticholic acid in combination with statin therapy on lipid metabolism in patients with nonalcoholic steatohepatitis.

In the CONTROL trial, up to 80 patients with NASH who are treatment-naive to statin therapy or have undergone a statin washout are expected to be enrolled. Each patient will participate in a 16-week, double-blind phase followed by an optional 2-year long-term safety extension phase.

The randomized, placebo-controlled study will include the following procedures of treatment: patients will evaluate three doses of obeticholic acid (OCA; 5 mg, 10 mg, 25 mg) or placebo with no concomitant statin therapy within the first 4 weeks of the trial; at 4 weeks, all patients will receive 10 mg of atorvastatin (10 mg) and will increase to 20 mg at 8 weeks; and at 12 weeks, doses of atorvastatin will be changed at the discretion of the patient’s individual physician through to the end of study, according to the release.

“We are committed to a broad and comprehensive clinical development program in NASH, given the significant unmet need for this serious condition,” Mark Pruzanski, MD, CEO and president of Intercept, said in the release. “Practice guidelines support statin use to treat dyslipidemia in NASH patients and we believe CONTROL will provide valuable information about OCA’s impact on lipid metabolism, as well as the ability of co-administered statins to manage LDL in this patient population, adding to the findings from our FLINT study.”

The FDA granted priority review of OCA for the treatment of primary biliary cirrhosis in September.

Disclosure: Pruzanski is employed by Intercept Pharmaceuticals.