A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
NCT ID: NCT04308590
Last Updated: 2025-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
137 participants
INTERVENTIONAL
2020-07-27
2024-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Relacorilant
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
Relacorilant
Relacorilant is supplied as blister-packed capsules for oral dosing. Relacorilant 400 mg dose consists of 4 relacorilant 100-mg capsules. Relacorilant 100-mg, 200-mg, and 300-mg doses are each given as a combination of 4 capsules containing relacorilant 100-mg and placebo as per the assigned dose.
Placebo
Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.
Placebo
Patients will receive placebo matched to study drug once daily.
Placebo
Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.
Interventions
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Relacorilant
Relacorilant is supplied as blister-packed capsules for oral dosing. Relacorilant 400 mg dose consists of 4 relacorilant 100-mg capsules. Relacorilant 100-mg, 200-mg, and 300-mg doses are each given as a combination of 4 capsules containing relacorilant 100-mg and placebo as per the assigned dose.
Placebo
Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels
* A radiologically confirmed adrenal lesion
* Has IGT or DM
* Has uncontrolled HTN
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Andreas Moraitis, MD
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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Site 27
Birmingham, Alabama, United States
Site 17
Stanford, California, United States
Site 53
Torrance, California, United States
Site 07
Atlanta, Georgia, United States
Site 16
Indianapolis, Indiana, United States
Site 09
Metairie, Louisiana, United States
Site 36
Baltimore, Maryland, United States
Site 11
Fall River, Massachusetts, United States
Site 33
Rochester, Minnesota, United States
Site 06
Jackson, Mississippi, United States
Site 54
Reno, Nevada, United States
Site 10
Jamaica, New York, United States
Site 44
New York, New York, United States
Site 01
Wilmington, North Carolina, United States
Site 30
Cleveland, Ohio, United States
Site 21
Columbus, Ohio, United States
Site 02
Summerville, South Carolina, United States
Site 20
Dallas, Texas, United States
Site 03
El Paso, Texas, United States
Site 05
Fort Worth, Texas, United States
Site 08
Houston, Texas, United States
Site 15
Spokane, Washington, United States
Site 25
Vienna, Vienna, Austria
Site 22
Sofia, , Bulgaria
Site 50
Munich, Bavaria, Germany
Site 46
Würzburg, , Germany
Site 32
Ramat Gan, , Israel
Site 23
Tel Aviv, , Israel
Site 40
Milan, Milano, Italy
Site 31
Rome, Roma, Italy
Site 43
Orbassano, Torino, Italy
Site 34
Milan, , Italy
Site 28
Napoli, , Italy
Site 51
Padua, , Italy
Site 37
Rome, , Italy
Site 52
Torino, , Italy
Site 48
Gliwice, , Poland
Site 47
Krakow, , Poland
Site 35
Lublin, , Poland
Site 42
Bucharest, , Romania
Site 38
Bucharest, , Romania
Site 41
Bucharest, , Romania
Site 14
Málaga, , Spain
Site 13
Seville, , Spain
Site 26
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CORT125134-456
Identifier Type: -
Identifier Source: org_study_id
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