A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant

Overview

About this study

The purpose of this study is to assess the effectiveness of Relacorilant for the treatment of hypercortisolism in patients with cortisol-secreting adrenal adenomas or hyperplasia, based on glycemic and blood pressure (BP) control at Week 22 compared with placebo. and to assess the safety of relacorilant for the treatment of hypercortisolism.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female.
  • 18 to 80 years of age, inclusive.
  • Lack of cortisol suppression (> 1.8 μg/dL serum cortisol with adequate dexamethasone levels) on either 1-mg overnight or 2-mg 48-hour DST during Screening.
  • Suppressed or low (≤15 pg/mL) early-morning ACTH levels on at least 2 occasions during Screening.
  • A radiologically confirmed adrenal lesion (single adenoma, multiple adenomas, hyperplasia [≥ 3 times the size of the normal adrenal gland]).
  • Has at least 1 of the following at Baseline:
    • DM (fasting plasma glucose ≥ 126 mg/dL and/or 2-hour oGTT plasma glucose ≥ 200  mg/dL at 2 hours, or HbA1c ≥ 6.5%), or IGT (plasma glucose ≥ 140 mg/dL and < 200 mg/dL on a 2-hour oGTT) (American Diabetes Association 2018);
    • Systolic hypertension (mean SBP ≥ 130 to ≤ 170 mm Hg) based on 24-hour ABPM (Parati et al. 2014).
  • If receiving medical treatment for DM/IGT or hypertension, they have been on a stable dose for at least 4 weeks prior to first dose of study medication.
  • For women of childbearing potential, has a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline.

Exclusion Criteria:

  • Has severe, uncontrolled hypertension (mean SBP > 170 mm Hg or mean DBP > 110 mm Hg at Screening), based on 24-hour ABPM.
  • Has poorly controlled DM (HbA1c > 12% at Screening).
  • Has abnormal liver test results (total bilirubin >1.5 × ULN or elevated alanine aminotransferase or aspartate aminotransferase >3 × ULN at Baseline).
  • Has severe renal insufficiency (glomerular filtration rate ≤ 29 mL/min at Baseline).
  • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
  • Has prolonged QT interval corrected for heart rate using Fridericia’s equation (QTcF) (> 450 ms for men and > 470 ms for women) with normal QRS interval (500 ms with wide QRS interval (≥ 120 ms).
  • Has persistent atrial fibrillation.
  • Has used or plans to use any treatments for Cushing syndrome within 12 weeks prior to Screening and throughout the study, including mifepristone, metyrapone, ketoconazole, fluconazole, or any investigational drug for treatment of Cushing syndrome.
  • Has adrenocortical carcinoma.
  • Has pseudo-Cushing syndrome. Patients with known or suspected pseudo-Cushing syndrome based on medical history (such as patients with severe obesity, major depression, or a history of alcoholism) should undergo a dexamethasone-CRH/DDAVP stimulation test (Yanovski et al.1993, Giraldi et al. 2007, Yanovski et al. 1998) to rule-in or rule-out this possibility.
  • Has autonomous cosecretion of aldosterone.
  • Has plans for adrenalectomy or nodulectomy during the study, including follow-up.
  • Has taken any non-Cushing syndrome investigational drug within 4 weeks prior to Baseline, or within less than 5 times the drug’s half-life, whichever is longer.
  • Ongoing use of antidiabetic, antihypertensive, antidepressant or lipid-lowering medications that are highly dependent on CYP3A for clearance and that cannot undergo dose modification upon coadministration with strong CYP3A inhibitors.
  • Ongoing use of any strong CYP3A inhibitor/inducer or any other prohibited medications.
  • Is pregnant or lactating.
  • Is a female patient of childbearing potential who cannot use a highly effective method of contraception (including all women < 50 years old, women whose surgical sterilization was performed <6 months ago, and women who have had a menstrual period in the last 2 years).
  • Has an acute or unstable medical problem that could be aggravated by treatment with the investigational study drug.
  • Has a history of severe reaction to the study drug, to a similar class of drug, or to the study drug’s excipient.
  • In the Investigator’s opinion, should not participate in the study or may not be capable of following the study schedule.
  • Taking medication for treatment of HIV, hepatitis B, or hepatitis C infection.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Irina Bancos, M.D.

Contact us for the latest status

Contact information:

Melinda Thomas B.S.

Thomas.Melinda@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20490977

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