CompletedPhase 3

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome

United States152 participantsStarted 2018-11-15

Plain-language summary

This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled 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: * Has a confirmed diagnosis of endogenous Cushing syndrome * Meets at least 1 of the following criteria: * Has Type 2 diabetes mellitus * Has impaired glucose tolerance * Has hypertension. Exclusion Criteria: * Has non-endogenous source of hypercortisolism * Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism * Has poorly controlled hypertension * Has poorly controlled diabetes mellitus * Has severe renal insufficiency.

What they're measuring

Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.

Timeframe: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

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

Timeframe: OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase

Trial details

NCT IDNCT03697109

SponsorCorcept Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-08

Results submitted2025-04-07

View on ClinicalTrials.gov More Cushing Syndrome trials