This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).
The primary outcome is the assessment of efficacy of relacorilant treatment based on sustained blood pressure control during the Randomized-withdrawal (RW) Phase, wherein patients who had achieved the blood pressure response criteria during the Open-label (OL) Phase are randomized to receive either relacorilant or placebo for 12 weeks. Patients in the OL Phase will dose-escalate in 100 mg increments to a maximum dose of 400 mg orally once daily. Patients will remain on OL treatment until Week 22 at which time they will be evaluated for the RW Phase based on predefined hyperglycemia and hypertension response criteria. Eligible patients will then be randomized to receive either relacorilant or placebo at a 1:1 ratio for 12 weeks. Patients who do not meet the criteria for the RW Phase will end treatment and may be eligible to roll over into an extension safety study. Patients who complete the RW Phase of the study may also be eligible to roll over into an extension study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
152
Relacorilant is supplied as 100 mg capsules for oral dosing.
Placebo matched to study drug
Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.
Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason.
Time frame: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.
Time frame: OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase
Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase
Time frame: Before and at time intervals up to 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Change in Hemoglobin HbA1c During the RW Phase
Time frame: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Change in 2-hour Plasma Glucose During the RW Phase
Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT).
Time frame: Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Change in SBP and DBP During the RW Phase
Blood pressure was measured by 24-hour ABPM.
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Site 21
Phoenix, Arizona, United States
Site 36
Los Angeles, California, United States
Site 68
Torrance, California, United States
Site 10
Miami, Florida, United States
Site 14
Atlanta, Georgia, United States
Site 41
Chicago, Illinois, United States
Site 7
Indianapolis, Indiana, United States
Site 2
Metairie, Louisiana, United States
Site 45
Baltimore, Maryland, United States
Site 46
Boston, Massachusetts, United States
...and 54 more locations
Time frame: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Change in Body Weight During the RW Phase
Time frame: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase
Time frame: Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase)