Corcept says Catalyst trial met primary endpoint

Corcept Therapeutics (CORT) Incorporated presented data from the randomized, double-blind, placebo-controlled treatment phase of its CATALYST trial of Korlym in patients with hypercortisolism and difficult-to-control type 2 diabetes at the American Diabetes Association’s 85th Scientific Sessions. CATALYST met its primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c, which decreased 1.47 percent from baseline, compared to a 0.15 percent decrease in patients who received placebo. Of the 91 patients in the treatment group, 65received at least 600mg of Korlym and 28 received 900mg. Patients who received 900mg of Korlym had an improvement in HbA1c of 2.01 percent, compared to a 0.16 percent decrease in patients who received placebo. The trial also met its secondary endpoints, as patients who received Korlym exhibited significantly reduced body weight and waist circumference, compared to patients who received placebo. Patients receiving Korlym achieved these improvements despite reducing or discontinuing their glucose-lowering medications. Adverse events in CATALYST were manageable and consistent with Korlym’s known safety profile. The most common adverse events were hypokalemia, fatigue and nausea.