NCT03697109CompletedPhase 3
A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant
Source: ClinicalTrials.gov · Last updated 16 Jul 2025
Brief summary (registry, in English)
This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- First submitted
- 27 Sept 2018
- Start date
- 15 Nov 2018
- Primary completion date
- 8 Apr 2024
- Lead sponsor
- Corcept Therapeutics
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT03697109
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 152
- From 15 Nov 2018 to the primary completion date, 8 Apr 2024
- 64 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has poorly controlled hypertension
- Has poorly controlled diabetes mellitus
- Has severe renal insufficiency.
Other
- Has non-endogenous source of hypercortisolism
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
Who the study is looking for
- Has a confirmed diagnosis of endogenous Cushing syndrome
- Meets at least 1 of the following criteria:
- Has Type 2 diabetes mellitus
- Has impaired glucose tolerance
- Has hypertension.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (64)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
- Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study.Lancet Diabetes Endocrinol · 2026 · PMID 41730814
This page is information, not medical advice. Discuss any trial with your doctor.