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

Short name GRADIENT

NCTNCT04308590Other idCORT125134-456

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures ACTH (corticotropin), does not give it. It appears in the eligibility rules.

Overview

Status: Completed
Phase: Phase 3
Enrollment: 137 participants (actual)
Sponsor: Corcept Therapeutics · Industry
Design: Randomized · Triple masking
Countries: 9 countries
United States, Austria, Bulgaria, Germany, Israel, Italy, Poland, Romania, Spain
Start: 27 Jul 2020
Primary completion: 19 Sept 2024
Completion: 19 Sept 2024
First posted: 16 Mar 2020
Last update posted: 4 Sept 2025
Conditions: Hypercortisolism

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022202320242025

Ph 3
GRADIENT
NCT04308590
27 Jul 2020 to 19 Sept 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

RelacorilantDrug
PlaceboOther

Arms2

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

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in Average 24-hour SBP
Time frame · Baseline and Week 22
Registry description
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.
Time frame · Baseline and up to Week 26

Secondary outcomes(15)

Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose)
Time frame · Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22
Registry description
AUCglucose was calculated based on results of the plasma 2-hour oGTT.
Change in Average Diastolic Blood Pressure (DBP)
Time frame · Baseline and Week 22
Registry description
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)
Time frame · Baseline and Week 22
Registry description
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
Time frame · Baseline and Week 22
Registry description
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
Time frame · Baseline and Week 22
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
Time frame · 2 hours post glucose drink at Week 22
Registry description
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
Time frame · 2 hours post glucose drink at Week 22
Registry description
Glucose was measured using the 2 hour timepoint of the 2-hour oGTT.
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)
Time frame · Baseline and Week 22
Registry description
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
Time frame · Baseline and Week 22
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline and Week 22

Change in Average 24-hour SBP

Group	Value (mm Hg)
Relacorilant	-5.56
Placebo	-2.89

Primary outcomeCount of participants· Baseline and up to Week 26

Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.

Group	Value (Participants)
Relacorilant	67
Placebo	60

Secondary and other outcome results(6)

Secondary outcomeLeast squares mean· Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22