Corcept Completes Enrollment in Phase 4 Trial
Corcept Therapeutics Incorporated recently announced completion of enrollment in CATALYST, a Phase 4 trial examining the prevalence of hypercortisolism (Cushing’s syndrome) in patients with difficult-to-control type 2 diabetes; patients with hypercortisolism may enter a randomized, placebo-controlled study of Korlym.
“With a total enrollment of more than 1,000 patients, CATALYST is the largest study ever conducted to establish the prevalence of hypercortisolism in this patient population,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Approximately 25% of the patients enrolled in CATALYST were identified as having hypercortisolism – which is substantially higher than previously assumed for this group. We look forward to sharing final prevalence data at the American Diabetes Association’s 84th Scientific Sessions in June and treatment data by year-end. We expect that the findings from CATALYST will guide physicians to better identify and treat patients with hypercortisolism.”
CATALYST is a prospective, Phase 4 study with two parts. The prevalence phase assesses the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes, which the study defines as hemoglobin A1c greater than 7.5% despite receiving optimal treatment. Patients from this group with a dexamethasone suppression test value greater than 1.8 µg/dL and dexamethasone levels greater than 140 ng/dL are identified as having hypercortisolism. Subject to satisfying additional screening criteria, these patients are eligible to enter CATALYST’s treatment phase, in which they are randomized, 2:1, to receive treatment with either Korlym or placebo for 24 weeks. CATALYST is being conducted at 35 sites in the US.
Hypercortisolism is caused by excessive activity of the endogenous hormone cortisol. Symptoms of hypercortisolism vary, but most patients experience one or more of the following manifestations: elevated blood sugar, difficult-to-control type 2 diabetes, hypertension, central obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively.
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients across a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept’s advanced clinical trials are being conducted in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease (NASH). In February 2012, the company introduced Korlym, the first medication approved by the US FDA for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Menlo Park, California. For more information, visit Corcept.com.
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