Corcept Presents CATALYST Trial Results at ADA Scientific Sessions

Results from the CATALYST clinical trial were presented at the American Diabetes Association’s 84th Scientific Sessions at a featured plenary session titled: “Prevalence of Hypercortisolism in Difficult-to-Control Type 2 Diabetes.”

CATALYST enrolled 1,055 patients across 36 sites in the United States, making it the largest and most rigorous study ever conducted to assess the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes. The results of this extensive study revealed that 24 percent of the patients had hypercortisolism. The condition was notably more prevalent among patients with cardiovascular disease, particularly those who required multiple medications to manage their hypertension, as well as among those who needed more drugs to control their diabetes.

"Until now, hypercortisolism has been widely regarded as extremely rare. But that turns out not to be true. These results show that hypercortisolism among patients with difficult-to-control type 2 diabetes is much more common than previously assumed and is likely the underlying cause of diabetes in many cases," explained Ralph DeFronzo, MD, chief of the Diabetes Division and professor of medicine at UT Health San Antonio and CATALYST study investigator. "These insights should lead to expanded screening for hypercortisolism, more effective treatment and better health outcomes for patients who are struggling today."

Bill Guyer, PharmD, Corcept’s Chief Development Officer, added, “Physicians haven’t been looking for hypercortisolism in their patients with difficult-to-control type 2 diabetes because they didn’t know how common it is. These data will enable physicians to more accurately diagnose and treat patients with hypercortisolism - a serious and deadly disease.”

CATALYST is a prospective, Phase 4 study consisting of two parts. The first phase assessed the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes, defined in the study as having hemoglobin A1c levels greater than 7.5 percent despite receiving optimal therapies, including GLP-1 agonists. Patients from this group with a dexamethasone suppression test (DST) value greater than 1.8 µg/dL and dexamethasone levels higher than 140 ng/dL were identified as having hypercortisolism. Those meeting additional screening criteria were eligible to enter the study’s treatment phase, where they were randomized, 2:1, to receive either Korlym® or a placebo. The results from the treatment phase are expected to be available by the end of the year.

Hypercortisolism, also known as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following: 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. Additionally, irritability, anxiety, cognitive disturbances, and depression are common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively.

For over 25 years, Corcept Therapeutics has focused on cortisol modulation and its potential to treat a wide variety of serious disorders. The company has discovered more than 1,000 proprietary selective cortisol modulators and is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS), and liver disease. In February 2012, Corcept introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for treating patients with Cushing’s syndrome. Corcept Therapeutics is headquartered in Menlo Park, California.