Improved Outcomes in Patients Receiving a GLP-1 with Difficult-to-Control Type 2 Diabetes and Hypercortisolism Treated with Korlym

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 presentation of new data from its CATALYST and MOMENTUM trials at the American Diabetes Association’s 86^th Scientific Sessions. The presentations underscore the critical role of hypercortisolism in difficult-to-control type 2 diabetes and resistant hypertension, and the potential of cortisol modulation treatment.

The CATALYST trial screened 1,057 patients with difficult-to-control type 2 diabetes (HbA1c of 7.5 – 11.5 percent despite receiving multiple glucose-lowering medications) and found that 24 percent had hypercortisolism (cortisol levels of greater than 1.8 μg/dL in the 1 mg dexamethasone suppression test (DST)). In CATALYST’s treatment phase, 136 of the patients who had been found to have hypercortisolism were randomized 2:1 to receive either Korlym or placebo for 24 weeks. Patients who received Korlym exhibited a clinically meaningful and statistically significant reduction in HbA1c (1.3 percent, p-value: <0.001). These patients also exhibited clinically meaningful reductions in body weight (5.1 kg), body mass index (1.7 kg/m²) and waist circumference (5.1 cm), compared to patients who received placebo (all nominal p-values less than 0.002). These findings were published in Diabetes Care in June 2025. The most common adverse events (>10 percent) were hypokalemia, fatigue, nausea, vomiting, headache, peripheral edema, diarrhea and dizziness.

The data presented at ADA described treatment outcomes in the 71 patients in CATALYST who were taking GLP-1 receptor agonists or the GLP-1/GIP agonist tirzepatide. In this group, patients who received Korlym exhibited numerically greater benefit than the overall study population with reductions in HbA1c (1.7 percent), body weight (6.1 kg), body mass index (2.0 kg/m²) and waist circumference (6.5 cm), compared to patients who received placebo (all nominal p-values less than 0.04).

“These new CATALYST data demonstrate the potential of cortisol modulation to improve critical metabolic parameters, even for patients who have poorly controlled type 2 diabetes despite treatment with powerful GLP-1 or GLP-1/GIP receptor agonists, such as semaglutide or tirzepatide. Excess cortisol disrupts the incretin system, impairs beta cell function, and induces insulin and incretin resistance, potentially limiting the effectiveness of these otherwise potent therapies. Screening for hypercortisolism and considering cortisol-directed treatment is a key part of managing type 2 diabetes in patients not responding to standard-of-care treatments,” said Lance Sloan, M.D., President, Texas Institute for Kidney and Endocrine Disorders.

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