A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas

Phase 3

Completed

• Conditions: Hypercortisolism
• Interventions: Drug: Relacorilant; Other: Placebo

• Registration Number: NCT04308590
• Lead Sponsor: Corcept Therapeutics

Brief Summary

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).

Detailed Description

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 Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-16
• Study Start: 2020-07-27
• Primary Completion: 2024-09-19
• Study Completion: 2024-09-19
• Results First Submitted: 2025-07-16
• Results First Submitted QC: 2025-07-16
• Status Verified: 2025-08
• Results First Posted: 2025-08-03
• Last Update Submitted: 2025-08-15
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Shows lack of cortisol suppression on dexamethasone suppression test
• Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels
• A radiologically confirmed adrenal lesion
• Has IGT or DM
• Has uncontrolled HTN

Exclusion Criteria

• Has severe, uncontrolled HTN
• Has poorly controlled DM
• Has DM Type 1
• Has significantly abnormal liver test results or severe renal insufficiency
• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relacorilant	Relacorilant	Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
Placebo	Placebo	Patients will receive placebo matched to study drug once daily.
Relacorilant	Placebo	Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.

Primary Outcome Measures

Name	Time	Method
Change in Average 24-hour SBP	Baseline and Week 22	Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported.
Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.	Baseline and up to Week 26

Secondary Outcome Measures

Name	Time	Method
Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose)	Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22	AUCglucose was calculated based on results of the plasma 2-hour oGTT.
Change in Average Diastolic Blood Pressure (DBP)	Baseline and Week 22	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.
Change in Average Heart Rate (HR)	Baseline and Week 22	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.
Change in Average Daytime and Nighttime SBP	Baseline and Week 22	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.
Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline	Baseline and Week 22
Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline	Baseline and Week 22
Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL	2 hours post glucose drink at Week 22	Glucose was measured using the 2 hour timepoint of the 2-hour oGTT.
Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL	2 hours post glucose drink at Week 22	Glucose was measured using the 2 hour timepoint of the 2-hour oGTT.
Number of Patients With Any Dose Decrease in Antihypertensive Medication	Baseline and Week 22
Number of Patients With Any Dose Decrease in Diabetes Medication	Baseline and Week 22
Number of Patients With Any Dose Increase or Switch in Antihypertensive Medication	Baseline and Week 22
Number of Patients With Any Dose Increase or Switch in Diabetes Medication	Baseline and Week 22
Number of Patients With HbA1c ≥6.5% at Baseline Who Achieved HbA1c <6.5%	Baseline and Week 22
Number of Patients With Normalization of the 24-hour Average SBP (<130 mm Hg)	Baseline and Week 22	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.
Number of Patients With a Reduction in 24-hour Average SBP by ≥5 mm Hg	Baseline and Week 22	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.

Trial Locations

Locations (45)

Site 27; 🇺🇸 Birmingham, Alabama, United States

Site 17; 🇺🇸 Stanford, California, United States

Site 53; 🇺🇸 Torrance, California, United States

Site 07; 🇺🇸 Atlanta, Georgia, United States

Site 16; 🇺🇸 Indianapolis, Indiana, United States

Site 09; 🇺🇸 Metairie, Louisiana, United States

Site 36; 🇺🇸 Baltimore, Maryland, United States

Site 11; 🇺🇸 Fall River, Massachusetts, United States

Site 33; 🇺🇸 Rochester, Minnesota, United States

Site 06; 🇺🇸 Jackson, Mississippi, United States

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