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 and/or uncontrolled systolic hypertension.

Detailed Description

This Phase 3 study 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: 2024-10-08
• Study Completion: 2024-10-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

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

Inclusion Criteria

• Shows lack of cortisol suppression
• Suppressed or low early-morning ACTH levels
• A radiologically confirmed adrenal lesion
• Has IGT or DM
• Has uncontrolled hypertension

Read More

Exclusion Criteria

• Has severe, uncontrolled hypertension
• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relacorilant	relacorilant	The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.
Placebo	Placebo	Placebo matched to study drug

Primary Outcome Measures

Name	Time	Method
The mean change in average systolic blood pressure (SBP) based on 24-hour ambulatory blood pressure monitoring (ABPM), from Baseline to Week 22 as compared between relacorilant and placebo arms	Baseline to week 22
Assessment of safety based on TEAEs	Baseline to week 22	Assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Mean change in AUCglucose, from baseline to Week 22 as compared between relacorilant and placebo arms	Baseline to Week 22/ET	Assessment based on AUCglucose Test
Mean change in average diastolic blood pressure (DBP)	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test
Mean change in average heart rate (HR)	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test
Mean change in daytime average diastolic blood pressure (DBP)	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test
Mean change in daytime average heart rate (HR)	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test
Mean change in daytime average systolic blood pressure (SBP)	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test
Mean change in HbA1c (HbA1c at Baseline greater than 5.7%)	Baseline to Week 22/ET	Assessment based on HbA1c Test
Mean change in HbA1c (HbA1c at Baseline greater than 6.5%)	Baseline to Week 22/ET	Assessment based on HbA1c Test
Mean change in nighttime average diastolic blood pressure (DBP)	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test
Mean change in nighttime average heart rate (HR)	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test
Mean change in nighttime average systolic blood pressure (SBP)	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test
Proportion of patients (DM) who achieved 2-hour oGTT glucose less than 140 mg/dL	Baseline to Week 22/ET	Assessment based on 2-hour oGTT Test
Proportion of patients (IGT) who achieved 2-hour oGTT glucose less than 140 mg/dL	Baseline to Week 22/ET	Assessment based on 2-hour oGTT Test
Proportion of patients with any dose decrease in antihypertensive medication due to improved blood pressure	Baseline to Week 22/ET
Proportion of patients with any dose decrease of diabetes medication due to improved glucose control	Baseline to Week 22/ET
Proportion of patients with any dose increase in antihypertensive medications due to worsening hypertension	Baseline to Week 22/ET
Proportion of patients with any dose increase of diabetes medication due to worsening hyperglycemia	Baseline to Week 22/ET
Proportion of patients with HbA1c greater than or equal to 6.5% at Baseline who achieved HbA1c less than 6.5%	Baseline to Week 22/ET	Assessment based on HbA1c Test
Proportion of patients with normalization of the average SBP (less than 130 mm Hg, based on 24-hour ABPM)	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test
Proportion of patients with a reduction in 24-hour average SBP by 5 mm Hg	Baseline to Week 22/ET	Assessment based on 24-hour ABPM Test

Trial Locations

Locations (45)

Site 21; 🇺🇸 Columbus, Ohio, United States

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

Site 54; 🇺🇸 Reno, Nevada, United States

Site 10; 🇺🇸 Jamaica, New York, United States

Site 44; 🇺🇸 New York, New York, United States

Site 01; 🇺🇸 Wilmington, North Carolina, United States

Site 30; 🇺🇸 Cleveland, Ohio, United States

Site 02; 🇺🇸 Summerville, South Carolina, United States

Site 20; 🇺🇸 Dallas, Texas, United States

Site 03; 🇺🇸 El Paso, Texas, United States

Site 05; 🇺🇸 Fort Worth, Texas, United States

Site 08; 🇺🇸 Houston, Texas, United States

Site 15; 🇺🇸 Spokane, Washington, United States

Site 25; 🇦🇹 Wien, Vienna, Austria

Site 22; 🇧🇬 Sofia, Bulgaria

Site 50; 🇩🇪 Munich, Bavaria, Germany

Site 46; 🇩🇪 Wuerzburg, Germany

Site 32; 🇮🇱 Ramat Gan, Israel

Site 23; 🇮🇱 Tel Aviv, Israel

Site 40; 🇮🇹 Milan, Milano, Italy

Site 31; 🇮🇹 Rome, Roma, Italy

Site 43; 🇮🇹 Orbassano, Torino, Italy

Site 34; 🇮🇹 Milan, Italy

Site 28; 🇮🇹 Napoli, Italy

Site 51; 🇮🇹 Padova, Italy

Site 37; 🇮🇹 Rome, Italy

Site 52; 🇮🇹 Torino, Italy

Site 48; 🇵🇱 Gliwice, Poland

Site 47; 🇵🇱 Krakow, Poland

Site 35; 🇵🇱 Lublin, Poland

Site 42; 🇷🇴 Bucharest, Romania

Site 38; 🇷🇴 Bucharest, Romania

Site 41; 🇷🇴 Bucharest, Romania

Site 14; 🇪🇸 Malaga, Spain

Site 13; 🇪🇸 Sevilla, Spain

Site 26; 🇪🇸 Valencia, Spain