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Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients with Cortisol-Secreting Adrenal Adenomas or (GRADIENT): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant

Clinical Trial Details

The purpose of this study is to find out whether the investigational study drug, relacorilant, is safe and effective in treating participants with hypercortisolism caused by adrenal adenomas or adrenal hyperplasia which is associated with elevated glucose levels, high blood pressure, or both. 

The study will look at how well relacorilant controls blood glucose and blood pressure, which are commonly elevated in participants with hypercortisolism. This study will also perform pharmacokinetic (PK) testing that measures the amount of relacorilant in the blood to understand how it is absorbed, broken down and removed by the body.
   
Relacorilant is currently being tested to evaluate the safety (side effects/risks) and efficacy (benefits), so its use for the treatment of hypercortisolism is experimental. Experimental means that it has not yet been approved by the U.S. Food and Drug Administration (FDA).
   
People with hypercortisolism have abnormal cortisol levels above the normal range. Cortisol acts by binding with the cortisol receptor in many tissues of the body. Relacorilant works by also binding with the cortisol receptor, thereby decreasing the effects of too much cortisol. Relacorilant doesn’t interact with any other receptors in the body other than the cortisol receptor.

Participants will be randomized into one of two treatment groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group. One group will receive relacorilant and the other will receive a placebo (a medication that looks like the study drug but contains no active ingredients).
   
Study participation will last for up to 32 weeks. Participants will need to come into the office at least 9 times throughout the study.

Key Eligibility: 
  1. Open to males or females ages 18 to 80 with cortisol-secreting adrenal adenomas or hyperplasia associated with Diabetes mellitus/impaired glucose tolerance and/or uncontrolled systolic hypertension. 
  2. Participants must not have uncontrolled hypertension OR poorly controlled Diabetes mellitus. 

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Blagovest Nikolov
bln2001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2009022691

ClinicalTrials.gov:

NCT04308590

Status

Open to Enrollment

Age Group

Adult