About the Korlym pivotal trial
Better glucose control
Patients receiving Korlym experienced significant improvements in AUCglucose, oGTT, and AUCinsulin—as early as 6 weeks1
See Glucose Improvements
Reductions in HbA1c and type 2 diabetes (T2D) medications
Patients receiving Korlym demonstrated significant reductions in their HbA1c, and many were able to reduce their doses of T2D medications1,2
See HbA1c Improvements
Decreased weight and depression*
Patients receiving Korlym showed decreases in their mean body weight, and decreased their symptoms of depression1
*Because of the variability in clinical presentation and variability of response in this open label trial, it is uncertain whether these changes could be ascribed to the effects of Korlym.3
Reach for Korlym to fight back with significant improvements in glucose control
60% (15/25) of patients achieved a 25% reduction from baseline in AUCglucose at week 24/ET1*†
Significant improvements in oGTT were seen as early as week 6 and continued through week 24.1
AUC, area under the curve; ET, early termination; HbA1c, hemoglobin A1c; oGTT, oral glucose tolerance test.
*In patients with Cushing syndrome and either T2D or impaired glucose tolerance.1
†Those with a ≥25% decrease in AUCglucose from baseline to week 24 were considered responders. This primary efficacy endpoint was considered met if ≥20% of patients were responders.1
Early and significant improvements in AUCinsulin
Improvements in AUCinsulin were seen as early as week 6 and continued through week 241
Results should be interpreted with caution, as these analyses were not adjusted for multiplicity and are observational in nature. No power considerations were taken to support definitive claims of efficacy.
Error bars in the graph are SD. A combined cohort of patients (n=33) not treated with insulin.
Reach for Korlym to fight back with reductions in HbA1c and T2D medications
Significant 1.1% reduction in HbA1c at week 241,2*
Patients experienced a significant 1.1% mean reduction by week 24/ET (n=25)
Patients with HbA1c baseline >7% experienced a significant 1.9% mean reduction by week 24/ET (n=12)
A majority of patients with HbA1c >7% at baseline reached their HbA1c goals.1
75% of patients achieved HbA1c goal <7% (n=9/12)
50% of patients achieved HbA1c goal <6% (n=6/12)
A significant 1.9% mean reduction was observed by week 24/ET (n=12).2
*In patients with Cushing syndrome and either T2D or impaired glucose tolerance.
Reductions in T2D medications
Some patients were able to reduce their T2D medications with Korlym:
of patients were able to
reduce their daily T2D
medication (n=7/15)3
of patients were able
to reduce their daily insulin by at
least half (n=5/12)1
Results should be interpreted with caution, as these analyses were not adjusted for multiplicity and are observational in nature. No power considerations were taken to support definitive claims of efficacy.
Changes in weight and depression
Patients treated with Korlym experienced a 5.7% (6.3 kg) reduction in mean body weight at week 24/ET1*†‡§
Most patients experienced reductions in body weight1‡:
of patients reduced
body weight by ≥5%
(n=24/46)
of patients reduced
body weight by ≥10%
(n=12/46)
Results should be interpreted with caution, as these analyses were not adjusted for multiplicity and are observational in nature. No power considerations were taken to support definitive claims of efficacy.
Because of the variability in clinical presentation and variability of response in the open-label trial, it is uncertain whether the change in body weight could be ascribed to the effects of Korlym.3
†In the modified intent-to-treat population, defined as patients who received >30 days of study medication.1
‡Mean baseline weight was 100 kg (range 61-199).1
§Mean baseline BMI was 35.7 kg/m2 in the intent-to-treat population.1
BMI, body mass index.
Patients experienced improvements in depression*
Nearly 60% of patients with mild-to-severe depression improved to minimal depression by week 24 (n=14/24)1,2,4
Results should be interpreted with caution, as these analyses were not adjusted for multiplicity and are observational in nature. No power considerations were taken to support definitive claims of efficacy.
*Because of the variability in clinical presentation and variability of response in the open-label trial, it is uncertain whether the change in psychiatric symptoms could be ascribed to the effects of Korlym.3
BDI-II, Beck Depression Inventory®-II.