CompletedPhase 3

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

United States137 participantsStarted 2020-07-27

Plain-language 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 (DM/IGT) and/or uncontrolled systolic hypertension (HTN).

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Shows lack of cortisol suppression on dexamethasone suppression test * Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels * A radiologically confirmed adrenal lesion * Has IGT or DM * Has uncontrolled HTN Exclusion Criteria: * Has severe, uncontrolled HTN * 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

What they're measuring

Change in Average 24-hour SBP

Timeframe: Baseline and Week 22

Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.

Timeframe: Baseline and up to Week 26

Trial details

NCT IDNCT04308590

SponsorCorcept Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-19

Results submitted2025-07-16

View on ClinicalTrials.gov More Hypercortisolism trials