Corcept Announces Preliminary Results From Prevalence Phase Of CATALYST Clinical Trial
Corcept Announces Preliminary Results From Prevalence Phase Of CATALYST Clinical Trial
February 15, 2024 at 4:02 PM EST
Of the first 700 patients enrolled in CATALYST, 24 percent were identified as having hypercortisolism – a prevalence rate that has been consistent throughout the study. Final results from the prevalence phase will be presented at the American Diabetes Association’s 84th Scientific Sessions in June.
“These results are very powerful. While cortisol’s role in diabetes is well understood, most diabetes care providers have not considered hypercortisolism as a source of the disease for their patients with difficult-to-control diabetes. These preliminary results clearly indicate that hypercortisolism should be considered – as the prevalence rate is significantly higher than previously assumed,” said
“We look forward to advancing this landmark study to completion,” said
About the Phase 4 CATALYST Study
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 percent despite receiving optimal therapies. 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. CATALYST is being conducted at 35 sites in
About
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
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business; risks related to the study and development of Korlym as well as relacorilant, miricorilant, dazucorilant and our other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our
In this press release, forward-looking statements include: the design, timing, expectations and final results regarding our CATALYST trial and its impact on the medical field’s rate of screening for and treatment of hypercortisolism. We disclaim any intention or duty to update forward-looking statements made in this press release.
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Source: Corcept Therapeutics Incorporated