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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypercortisolism

Intervention / Treatment
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* Drug: relacorilant
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relacorilant<br>The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily. | Drug: relacorilant<br>* Relacorilant is supplied as 100 mg capsules for oral dosing.<br>|
| Placebo Comparator: Placebo<br>Placebo matched to study drug | Other: Placebo<br>* Placebo is supplied as 100 mg capsules for oral dosing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In patients with diabetes/ impaired glucose tolerance (DM/IGT), the mean change in AUC glucose as compared between relacorilant and placebo arm |  | 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 |  | Baseline to week 22 | 
| Rate of safety based TEAEs | Assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0. | Baseline to week 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In patients with DM at baseline the mean change in HbA1c and fasting glucose |  | Baseline to week 22/ET | 
| Proportion of patients with IGT at Baseline who achieved normalization of 2-hour oGTT glucose |  | Week 22/ET | 
| Proportion of patients with normalization of the mean SBP |  | Baseline to week 22/ET | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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