Diabetes Care Publishes Results From Prevalence Phase Of Corcept’s CATALYST Trial In People With Difficult-To-Control Type 2 Diabetes

Hypercortisolism identified in 24 percent of patients with difficult-to-control type 2 diabetes

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced the publication of findings from the prevalence phase of the CATALYST trial in Diabetes Care, a peer-reviewed journal published by the American Diabetes Association.

The publication, Prevalence of Hypercortisolism in Difficult-to-Control Type 2 Diabetes, can be accessed at: https://diabetesjournals.org/care/lookup/doi/10.2337/dc24-2841.

CATALYST was the largest and most rigorous trial ever conducted to assess the prevalence of hypercortisolism (Cushing’s syndrome) in patients with difficult-to-control type 2 diabetes. Part one of the study screened 1,057 patients at 36 sites across the United States. All patients had hemoglobin A1c greater than 7.5 percent, despite receiving multiple glucose-lowering therapies, including GLP-1 receptor agonists. Using a simple, standardized 1-mg dexamethasone suppression test (DST), 24 percent of these patients were found to have hypercortisolism. These findings were first presented at the American Diabetes Association Scientific Sessions in June 2024.

“Many patients have uncontrolled type 2 diabetes despite the use of the best available medications,” said lead author John Buse, M.D., Ph.D., director of the University of North Carolina’s Diabetes Center. “It is critical for clinicians to consider and address all factors that can contribute to inadequate glucose control. CATALYST’s results show that, for many patients, hypercortisolism is one of those factors.”

Part two of CATALYST– a randomized, double-blind, placebo-controlled study of Korlym^® in patients with hypercortisolism and difficult-to-control type 2 diabetes – met its primary endpoint of reduction in hemoglobin A1c. Topline results were announced in December 2024, and complete results will be presented at the American Diabetes Association’s 85^th Scientific Sessions on June 23, 2025, at a symposium titled: “Treatment of Hypercortisolism in People with Difficult-to-Control Type 2 Diabetes – Final Results of the CATALYST Trial.”

“CATALYST provides valuable insights into an often-unrecognized cause of difficult-to-control type 2 diabetes,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “These prevalence data, in combination with data from the treatment phase of the study, will hopefully help patients with hypercortisolism receive the diagnosis and care they need.”

About Hypercortisolism (Cushing’s Syndrome)

Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively.

About Corcept Therapeutics

For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym^®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.

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 expressed or implied by such statements. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym®, relacorilant, miricorilant, dazucorilant and our other product candidates, as well as those molecules’ 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 SEC filings, which are available at our website and the SEC’s website.

In this press release, forward-looking statements include: the design, timing, expectations and results of our CATALYST trial and its impact on the medical field’s 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

FAQ

What percentage of difficult-to-control type 2 diabetes patients showed hypercortisolism in CORT's CATALYST trial?

24% of patients with difficult-to-control type 2 diabetes were found to have hypercortisolism through the 1-mg dexamethasone suppression test.

How many patients and sites were involved in CORT's CATALYST trial prevalence phase?

The study screened 1,057 patients across 36 sites in the United States.

Did Korlym achieve its primary endpoint in CORT's CATALYST trial for diabetes?

Yes, part two of CATALYST met its primary endpoint of reduction in hemoglobin A1c levels.

When will the complete results of CORT's CATALYST trial be presented?

The complete results will be presented at the American Diabetes Association's 85th Scientific Sessions on June 23, 2025.

What were the inclusion criteria for patients in CORT's CATALYST trial?

Patients had hemoglobin A1c greater than 7.5 percent despite receiving multiple glucose-lowering therapies, including GLP-1 receptor agonists.