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

Hypercortisolism Clinical Trial

— GRADIENT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04308590
• Other study ID #: CORT125134-456
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 27, 2020
• Est. completion date: September 27, 2024

Study information

• Verified date: June 2024
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: September 27, 2024
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 DM Type 1

• Has significantly abnormal liver test results or severe renal insufficiency

• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Related Conditions & MeSH terms

• Adenoma
• Adrenocortical Adenoma
• Adrenocortical Hyperfunction
• Cushing Syndrome
• Hypercortisolism

Intervention

Drug:
• relacorilant
Relacorilant is supplied as 100 mg capsules for oral dosing.

Other:
• Placebo
Placebo is supplied as 100 mg capsules for oral dosing.

Locations

Country	Name	City	State
Austria	Site 25	Wien	Vienna
Bulgaria	Site 22	Sofia
Germany	Site 50	Munich	Bavaria
Germany	Site 46	Wuerzburg
Israel	Site 24	Kfar-Saba
Israel	Site 18	Petach Tikva
Israel	Site 32	Ramat Gan
Israel	Site 23	Tel Aviv
Italy	Site 34	Milan
Italy	Site 40	Milan	Milano
Italy	Site 28	Napoli
Italy	Site 43	Orbassano	Torino
Italy	Site 51	Padova
Italy	Site 31	Rome	Roma
Italy	Site 37	Rome
Italy	Site 52	Torino
Poland	Site 48	Gliwice
Poland	Site 47	Krakow
Poland	Site 35	Lublin
Romania	Site 38	Bucharest
Romania	Site 41	Bucharest
Romania	Site 42	Bucharest
Spain	Site 29	Girona
Spain	Site 14	Malaga
Spain	Site 13	Sevilla
Spain	Site 26	Valencia
United States	Site 45	Ann Arbor	Michigan
United States	Site 07	Atlanta	Georgia
United States	Site 36	Baltimore	Maryland
United States	Site 27	Birmingham	Alabama
United States	Site 30	Cleveland	Ohio
United States	Site 21	Columbus	Ohio
United States	Site 20	Dallas	Texas
United States	Site 03	El Paso	Texas
United States	Site 11	Fall River	Massachusetts
United States	Site 05	Fort Worth	Texas
United States	Site 08	Houston	Texas
United States	Site 16	Indianapolis	Indiana
United States	Site 06	Jackson	Mississippi
United States	Site 10	Jamaica	New York
United States	Site 09	Metairie	Louisiana
United States	Site 44	New York	New York
United States	Site 54	Reno	Nevada
United States	Site 33	Rochester	Minnesota
United States	Site 15	Spokane	Washington
United States	Site 17	Stanford	California
United States	Site 02	Summerville	South Carolina
United States	Site 53	Torrance	California
United States	Site 01	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Germany,  Israel,  Italy,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In patients with diabetes/ impaired glucose tolerance (DM/IGT), the mean change in AUC glucose as compared between relacorilant and placebo arm		Baseline to week 22
Primary	In patients with systolic hypertension, the change in mean systolic blood pressure (SBP) based on 24-hour ambulatory blood pressure monitor (ABPM) as compared between relacorilant and placebo arms		Baseline to week 22
Primary	Rate of safety based TEAEs	Assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.	Baseline to week 22
Secondary	In patients with DM at baseline the mean change in HbA1c and fasting glucose		Baseline to week 22/ET
Secondary	Proportion of patients with IGT at Baseline who achieved normalization of 2-hour oGTT glucose		Week 22/ET
Secondary	Proportion of patients with normalization of the mean SBP		Baseline to week 22/ET