The FDA-approved Prescribing Information for Korlym includes data from the SEISMIC clinical trial. The presentation below contains data regarding Korlym that are not included in the approved Prescribing Information and have not been reviewed by the FDA. Please review results from the SEISMIC trial, and keep them in mind while exploring additional data.
CATALYST was a 2-part study on the prevalence & treatment of endogenous hypercortisolism1,3*
In the Screening Phase of CATALYST, almost 1 in 4 (252 of 1057) patients with difficult-to-control T2D showed evidence of endogenous hypercortisolism.
In the Treatment Phase, Korlym demonstrated significant HbA1c reductions in a subset of appropriate patients with difficult-to-control T2D and endogenous hypercortisolism.2,3
Significant reductions in HbA1c–with or without adrenal abnormalities2
In the Treatment Phase of CATALYST, patients with endogenous hypercortisolism who received Korlym showed clinically significant reductions in HbA1c, whether or not they had adrenal abnormalities.
Decreased dosing or discontinuation of T2D medications2
In the Treatment Phase of CATALYST, many patients with endogenous hypercortisolism who received Korlym were able to decrease their doses or completely discontinue common T2D medications.
Improvements in body composition2
In the Treatment Phase of CATALYST, patients with endogenous hypercortisolism who received Korlym improved their body composition with weight loss and reductions in waist circumference.
CATALYST was a prospective, phase 4 study with two parts. The first part (Screening Phase) assessed the prevalence of endogenous hypercortisolism in 1057 patients with difficult-to-control T2D diagnosed ≥1 year prior and defined as HbA1c 7.5%-11.5% AND taking ≥3 T2D medications OR insulin and other T2D medication(s) OR ≥2 T2D medications AND the presence of ≥1 microvascular or macrovascular complication AND/OR concomitant hypertension requiring ≥2 hypertension medications. Hypercortisolism was defined as a post 1-mg DST cortisol >1.8 μg/dL with AM dexamethasone ≥140 ng/dL. In the second part (Treatment Phase), patients with hypercortisolism who met inclusion/exclusion criteria (n=136) were randomized (2:1) to receive either Korlym or placebo for 24 weeks in a double-blind, placebo-controlled manner. The primary endpoint was the reduction of HbA1c between these groups. Please see full study design on this page.1,3
Significant HbA1c changes were observed with Korlym2,4
Patients treated with Korlym experienced a statistically significant 1.47% change in HbA1c at week 24
Baseline HbA1c was 8.62% for patients treated with Korlym, and 8.41% in patients treated with placebo2
In patients who completed the CATALYST study, patients treated with Korlym (n=47) experienced a clinically meaningful -1.7% (95% CI: -2.1, -1.3) change in HbA1c vs -0.1% (95% CI: -0.6, 0.3) in patients treated with placebo (n=36)2
CI, confidence interval; HbA1c, hemoglobin A1c; LS, least-squares.
N=136 patients enrolled; randomized 2:1 to mifepristone (n=91) or placebo (n=45). P-value for change from baseline to week 24 (within arm) based on Wilcoxon signed rank test.
Least-square mean, confidence interval, and P-value between treatment arms based on a Mixed Model for Repeated Measures (MMRM).
Clinically meaningful changes in HbA1c at week 24 were observed in patients treated with Korlym, both with and without an adrenal imaging abnormality compared with placebo2,4
A change in HbA1c was observed in patients with hypercortisolism and difficult-to-control T2D treated with Korlym, regardless of the presence of an adrenal imaging abnormality
Additional improvements were observed with Korlym2
Patients taking Korlym experienced early reductions or discontinuation of concomitant antihyperglycemic medication by week 12
| Korlym | Placebo | |
|---|---|---|
| Fast-acting insulin | 30.3% (10/33) | 10.5% (2/19) |
| Long- or intermediate-acting insulin | 49.2% (32/65) | 13.0% (3/23) |
| Sulfonylureas | 22.2% (4/18) | 10.5% (2/19) |
Patients taking Korlym also experienced improvements in body composition at week 242
BODY WEIGHT‡
-4.4 kg change with Korlym (95% CI: -6.3, -2.5) vs
+0.72 kg increase with placebo (95% CI: -1.8, 3.3)
BMI¶
-1.47 kg/m2 change with Korlym (95% CI: -2.1, -0.8) vs +0.28 kg/m2 increase with placebo (95% CI: -0.6, 1.1)
WAIST CIRCUMFERENCE§
-5.2 cm change with Korlym (95% CI: -7.3, -3.2) vs
-0.1 cm change with placebo (95% CI: -2.7, 2.5)
-0.1 cm change with placebo (95% CI: -2.7, 2.5)
‡Baseline mean body weight: Korlym group: 99.7 kg; placebo group: 97.4 kg.3
¶Baseline mean BMI: Korlym group: 33.1 kg/m2; placebo group: 33.7 kg/m2.3
§Baseline mean waist circumference: Korlym group: 114.0 cm; placebo group: 115.3 cm.3