Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas (GRADIENT)

• ClinicalTrials.gov Identifier: NCT04308590
• Recruitment Status: Recruiting
• First Posted: March 16, 2020
• Last Update Posted: November 12, 2020
• Sponsor: Corcept Therapeutics
• Information provided by (Responsible Party): Corcept Therapeutics

Tracking Information

• First Submitted Date: February 27, 2020
• First Posted Date: March 16, 2020
• Last Update Posted Date: November 12, 2020
• Actual Study Start Date: May 19, 2020
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 11, 2020)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 11, 2020)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
• 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
• 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.
• Detailed Description: This Phase 3 study patients will be randomized in a 1:1 ratio to treatment with relacorilant (active drug) or placebo. Patients will receive relacorilant or placebo for 22 weeks. Patients who complete the study may also be eligible to roll over into an extension study.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Hypercortisolism

Intervention

• Drug: relacorilant
  Relacorilant is supplied as 100 mg capsules for oral dosing.
• Other: Placebo
  Placebo is supplied as 100 mg capsules for oral dosing.

Study Arms

• 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.
  Intervention: Drug: relacorilant
• Placebo Comparator: Placebo
  Placebo matched to study drug
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 11, 2020): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2021
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Eligibility 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 significantly abnormal liver test results or severe renal insufficiency
• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Trial Lead; 650 327 3270; GRADIENTstudy@corcept.com

• Listed Location Countries: Spain, United States

Administrative Information

• NCT Number: NCT04308590
• Other Study ID Numbers: CORT125134-456
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Corcept Therapeutics
• Study Sponsor: Corcept Therapeutics
• Collaborators: Not Provided

Investigators

• Study Director: Andreas Moraitis, MD; Corcept Therapeutics

• PRS Account: Corcept Therapeutics
• Verification Date: August 2020