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NCT04308590 (Relacorilant in Hypercortisolism): BVCT ex-ante prediction vs. reported outcome

On 16 Jul 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 30 Oct 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04308590
Acronym
GRADIENT
Drug Name
Relacorilant
Drug MoA
oral non-steroidal glucocorticoid receptor antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Endocrine System Diseases
Indication
Hypercortisolism
Human Patients
137
Sponsor
Corcept Therapeutics
Phase
Phase 3

Prediction of , index 546

Prospective Prediction
Prediction Index
546
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
472 days in advance
Readout Data Interpretation
relacorilant failed to achieve the mean SBP primary efficacy endpoint against placebo
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia (GRADIENT): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant
Phase
Phase 3
Status
Completed
Enrollment
137
Lead sponsor
Corcept Therapeutics
Conditions
Hypercortisolism
Interventions
DRUG: Relacorilant; OTHER: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2020-07-27
Primary completion
2024-09-19
Completion
2024-09-19
Results first posted
2025-08-03
Primary outcomes
  • Change in Average 24-hour SBP (Baseline and Week 22)
  • Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. (Baseline and up to Week 26)

NCT04308590 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials