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Corticosteroid

relacorilant for Cushing's Syndrome (GRADIENT Trial)

Phase 3
Recruiting
Research Sponsored by Corcept Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 22/et
Awards & highlights

GRADIENT Trial Summary

This trial will test if relacorilant is an effective and safe treatment for hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance and/or uncontrolled systolic hypertension.

Who is the study for?
This trial is for people with cortisol-secreting adrenal adenomas, which can cause Cushing's Syndrome. Participants should have issues with blood sugar control or high blood pressure not managed by medication. They must also show specific hormone levels and have a confirmed adrenal lesion on scans. Those with uncontrolled thyroid issues, severe hypertension, type 1 diabetes, or major liver/kidney problems cannot join.Check my eligibility
What is being tested?
The study is testing the effectiveness of relacorilant compared to a placebo in treating high cortisol levels due to adrenal tumors. It's designed as a Phase 3 trial where participants are randomly assigned to receive either the drug or an inactive substance without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
Potential side effects of relacorilant may include changes in blood pressure and blood sugar levels, digestive discomforts like nausea or vomiting, hormonal imbalances that could affect mood and energy levels, and possible allergic reactions.

GRADIENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 22/et
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 22/et for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
In patients with diabetes/ impaired glucose tolerance (DM/IGT), the mean change in AUC glucose as compared between relacorilant and placebo arm
In patients with systolic hypertension, the change in mean systolic blood pressure (SBP) based on 24-hour ambulatory blood pressure monitor (ABPM) as compared between relacorilant and placebo arms
Rate of safety based TEAEs
Secondary outcome measures
In patients with DM at baseline the mean change in HbA1c and fasting glucose
Proportion of patients with IGT at Baseline who achieved normalization of 2-hour oGTT glucose
Proportion of patients with normalization of the mean SBP

GRADIENT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RelacorilantExperimental Treatment1 Intervention
The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.
Group II: PlaceboPlacebo Group1 Intervention
Placebo matched to study drug

Find a Location

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,250 Total Patients Enrolled
7 Trials studying Cushing's Syndrome
171 Patients Enrolled for Cushing's Syndrome
Andreas Moraitis, MDStudy DirectorCorcept Therapeutics
1 Previous Clinical Trials
152 Total Patients Enrolled

Media Library

Relacorilant (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04308590 — Phase 3
Cushing's Syndrome Research Study Groups: Placebo, Relacorilant
Cushing's Syndrome Clinical Trial 2023: Relacorilant Highlights & Side Effects. Trial Name: NCT04308590 — Phase 3
Relacorilant (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04308590 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research being conducted in a few hospitals or many?

"The clinical trial has 23 active locations, including Site 02 in Summerville, Site 15 in Spokane, and Site 11 in Fall River."

Answered by AI

Are adults aged 55 and older welcome in this clinical trial?

"The listed inclusion criteria on this study specify that patients must be aged 18 to 80. Out of the 16 total trials, 105 are for patients over the age of 65."

Answered by AI

Are there other examples in medical research of drugs like relacorilant?

"There are currently six ongoing studies into relacorilant. Out of these, two are in Phase 3. The trials for relacorilant are being conducted in 215 different locations, with a significant presence in Bucuresti and Oklahoma."

Answered by AI

Is this a new method for testing treatments?

"Relacorilant has undergone six clinical trials in the past few years, spanning 53 cities across 12 countries. The first study was sponsored by Corcept Therapeutics in 2018. That trial completed its Phase 2 drug approval stage and involved 75 patients. Since then, 18275 more trials have been conducted."

Answered by AI

Has relacorilant been certified by the Federal Drug Administration?

"Relacorilant received a safety rating of 3 because, as a Phase 3 trial medication, there is both efficacy and multiple rounds of safety data supporting its use."

Answered by AI

What is the maximum number of individuals allowed to enroll in this experimental program?

"Corcept Therapeutics, the sponsor of this study, needs to enroll 130 eligible patients at multiple clinical sites. For example, Site 02 is located in Summerville, South carolina and Site 15 is in Spokane, Washington."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
2020. "Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04308590.
~28 spots leftby Apr 2025
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