Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas (GRADIENT)
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| ClinicalTrials.gov Identifier: NCT04308590 |
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Recruitment Status :
Recruiting
First Posted : March 16, 2020
Last Update Posted : March 28, 2023
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Sponsor:
Corcept Therapeutics
Information provided by (Responsible Party):
Corcept Therapeutics
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Brief Summary:
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 and/or uncontrolled systolic hypertension.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypercortisolism | Drug: relacorilant Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 130 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 19, 2020 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cushing disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: Relacorilant
The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.
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Drug: relacorilant
Relacorilant is supplied as 100 mg capsules for oral dosing. |
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Placebo Comparator: Placebo
Placebo matched to study drug
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Other: Placebo
Placebo is supplied as 100 mg capsules for oral dosing. |
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 [ 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.
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Shows lack of cortisol suppression
- Suppressed or low early-morning ACTH levels
- A radiologically confirmed adrenal lesion
- Has IGT or DM
- Has uncontrolled hypertension
Exclusion Criteria:
- Has severe, uncontrolled hypertension
- Has poorly controlled DM
- Has DM Type 1
- Has significantly abnormal liver test results or severe renal insufficiency
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
Information from the National Library of Medicine
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
Contacts
| Contact: Clinical Trial Lead | 650 327 3270 | GRADIENTstudy@corcept.com |
Locations
Show 52 study locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
| Study Director: | Andreas Moraitis, MD | Corcept Therapeutics |
| Responsible Party: | Corcept Therapeutics |
| ClinicalTrials.gov Identifier: | NCT04308590 |
| Other Study ID Numbers: |
CORT125134-456 |
| First Posted: | March 16, 2020 Key Record Dates |
| Last Update Posted: | March 28, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Corcept Therapeutics:
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Cushing syndrome Cushing Hypercortisolemia Type 2 Diabetes Impaired Glucose Intolerance Hypertension Adrenocorticotropic hormone |
Primary Pigmented Nodular Adrenal Disease Macronodular adrenal hyperplasia Adrenal Adenoma Adrenal Autonomy Cortisol Autonomous cortisol secretion |
Additional relevant MeSH terms:
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Adenoma Adrenocortical Adenoma Cushing Syndrome Adrenocortical Hyperfunction Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Adrenal Gland Diseases Endocrine System Diseases Adrenal Cortex Neoplasms Adrenal Gland Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Adrenal Cortex Diseases |