Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas (GRADIENT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04308590|
Recruitment Status : Not yet recruiting
First Posted : March 16, 2020
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypercortisolism||Drug: relacorilant Other: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.
Relacorilant is supplied as 100 mg capsules for oral dosing.
Placebo Comparator: Placebo
Placebo matched to study drug
Placebo is supplied as 100 mg capsules for oral dosing.
- In patients with diabetes/ impaired glucose tolerance (DM/IGT), the mean change in AUC glucose as compared between relacorilant and placebo arm [ Time Frame: Baseline to week 22 ]
- 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 [ Time Frame: Baseline to week 22 ]
- Rate of safety based TEAEs [ Time Frame: Baseline to week 22 ]Assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.
- In patients with DM at baseline the mean change in HbA1c and fasting glucose [ Time Frame: Baseline to week 22/ET ]
- Proportion of patients with IGT at Baseline who achieved normalization of 2-hour oGTT glucose [ Time Frame: Week 22/ET ]
- Proportion of patients with normalization of the mean SBP [ Time Frame: Baseline to week 22/ET ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308590
|Contact: Clinical Trial Lead||650 327 3270||GRADIENTstudy@corcept.com|
|Study Director:||Andreas Moraitis, MD||Corcept Therapeutics|