This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance (DM/IGT) and/or uncontrolled systolic hypertension (HTN).
The primary outcome measures of the study are 1) to assess the efficacy of relacorilant based on blood pressure control at Week 22 compared with placebo, and 2) to assess the safety of relacorilant based on adverse events. Patients will be randomized in a 1:1 ratio to treatment with relacorilant (active drug) or placebo. Patients will receive relacorilant or placebo for 22 weeks. Patients who complete the study may also be eligible to roll over into an extension study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
137
Relacorilant is supplied as blister-packed capsules for oral dosing. Relacorilant 400 mg dose consists of 4 relacorilant 100-mg capsules. Relacorilant 100-mg, 200-mg, and 300-mg doses are each given as a combination of 4 capsules containing relacorilant 100-mg and placebo as per the assigned dose.
Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.
Change in Average 24-hour SBP
Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported.
Time frame: Baseline and Week 22
Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.
Time frame: Baseline and up to Week 26
Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose)
AUCglucose was calculated based on results of the plasma 2-hour oGTT.
Time frame: Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22
Change in Average Diastolic Blood Pressure (DBP)
Blood pressure was measured by 24-hour ABPM. Daytime average DBP was measured from 06:00 to 21:59. Nighttime average DBP was measure from 22:00 to 05:59.
Time frame: Baseline and Week 22
Change in Average Heart Rate (HR)
Heart rate was measured by 24-hour ABPM. Daytime average HR was measured from 06:00 to 21:59. Nighttime average HR was measure from 22:00 to 05:59.
Time frame: Baseline and Week 22
Change in Average Daytime and Nighttime SBP
Blood pressure was measured by 24-hour ABPM. Daytime average SBP was measured from 06:00 to 21:59. Nighttime average SBP was measure from 22:00 to 05:59.
Time frame: Baseline and Week 22
Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline
Time frame: Baseline and Week 22
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Torrance, California, United States
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Atlanta, Georgia, United States
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Indianapolis, Indiana, United States
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Metairie, Louisiana, United States
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Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline
Time frame: Baseline and Week 22
Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL
Glucose was measured using the 2 hour timepoint of the 2-hour oGTT.
Time frame: 2 hours post glucose drink at Week 22
Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL
Glucose was measured using the 2 hour timepoint of the 2-hour oGTT.
Time frame: 2 hours post glucose drink at Week 22
Number of Patients With Any Dose Decrease in Antihypertensive Medication
Time frame: Baseline and Week 22
Number of Patients With Any Dose Decrease in Diabetes Medication
Time frame: Baseline and Week 22
Number of Patients With Any Dose Increase or Switch in Antihypertensive Medication
Time frame: Baseline and Week 22
Number of Patients With Any Dose Increase or Switch in Diabetes Medication
Time frame: Baseline and Week 22
Number of Patients With HbA1c ≥6.5% at Baseline Who Achieved HbA1c <6.5%
Time frame: Baseline and Week 22
Number of Patients With Normalization of the 24-hour Average SBP (<130 mm Hg)
Blood pressure was measured by 24-hour ABPM Test. Reported is the number of patients with HTN at Baseline who achieved SBP \<130 mm Hg at Week 22.
Time frame: Baseline and Week 22
Number of Patients With a Reduction in 24-hour Average SBP by ≥5 mm Hg
Blood pressure was measured by 24-hour ABPM. Reported is the number of patients with HTN at Baseline who achieved at least a 5 mm Hg reduction in 24-hour average SBP at Week 22.
Time frame: Baseline and Week 22