Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia (GRADIENT): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant
Who is this study for? Patients with Hypercortisolism
What treatments are being studied? Relacorilant
Status: Completed
Location: See all (45) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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 (DM/IGT) and/or uncontrolled systolic hypertension (HTN).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Shows lack of cortisol suppression on dexamethasone suppression test
• Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels
• A radiologically confirmed adrenal lesion
• Has IGT or DM
• Has uncontrolled HTN
Locations
United States
Alabama
Site 27
Birmingham
California
Site 17
Stanford
Site 53
Torrance
Georgia
Site 07
Atlanta
Indiana
Site 16
Indianapolis
Louisiana
Site 09
Metairie
Massachusetts
Site 11
Fall River
Maryland
Site 36
Baltimore
Minnesota
Site 33
Rochester
Mississippi
Site 06
Jackson
North Carolina
Site 01
Wilmington
Nevada
Site 54
Reno
New York
Site 10
Jamaica
Site 44
New York
Ohio
Site 30
Cleveland
Site 21
Columbus
South Carolina
Site 02
Summerville
Texas
Site 20
Dallas
Site 03
El Paso
Site 05
Fort Worth
Site 08
Houston
Washington
Site 15
Spokane
Other Locations
Austria
Site 25
Vienna
Bulgaria
Site 22
Sofia
Germany
Site 50
Munich
Site 46
Würzburg
Israel
Site 32
Ramat Gan
Site 23
Tel Aviv
Italy
Site 34
Milan
Site 40
Milan
Site 28
Napoli
Site 43
Orbassano
Site 51
Padua
Site 31
Rome
Site 37
Rome
Site 52
Torino
Poland
Site 48
Gliwice
Site 47
Krakow
Site 35
Lublin
Romania
Site 38
Bucharest
Site 41
Bucharest
Site 42
Bucharest
Spain
Site 14
Málaga
Site 13
Seville
Site 26
Valencia
Time Frame
Start Date: 2020-07-27
Completion Date: 2024-09-19
Participants
Target number of participants: 137
Treatments
Experimental: Relacorilant
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
Placebo_comparator: Placebo
Patients will receive placebo matched to study drug once daily.
Related Therapeutic Areas
Sponsors
Leads: Corcept Therapeutics