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

  • STATUS
    Recruiting
  • days left to enroll
    24
  • participants needed
    130
  • sponsor
    Corcept Therapeutics
Updated on 7 October 2022
diabetes
hypertension
adenoma
corticotropin
hypercortisolism
hyperplasia
adrenal adenoma
relacorilant

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.

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.

Details
Condition Hypercortisolism
Treatment Placebo, Relacorilant
Clinical Study IdentifierNCT04308590
SponsorCorcept Therapeutics
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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 DM Type 1
Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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