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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Epinephrine; Epinephryl borate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Racepinephrine

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