A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
NCT ID: NCT03697109
Last Updated: 2025-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
152 participants
INTERVENTIONAL
2018-11-15
2024-04-15
Brief Summary
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Detailed Description
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Patients in the OL Phase will dose-escalate in 100 mg increments to a maximum dose of 400 mg orally once daily. Patients will remain on OL treatment until Week 22 at which time they will be evaluated for the RW Phase based on predefined hyperglycemia and hypertension response criteria. Eligible patients will then be randomized to receive either relacorilant or placebo at a 1:1 ratio for 12 weeks. Patients who do not meet the criteria for the RW Phase will end treatment and may be eligible to roll over into an extension safety study. Patients who complete the RW Phase of the study may also be eligible to roll over into an extension study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Relacorilant (OL Phase)
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 100 mg capsules for oral dosing.
Relacorilant (RW Phase)
Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase.
Relacorilant
Relacorilant is supplied as 100 mg capsules for oral dosing.
Placebo (RW Phase)
Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug.
Placebo
Placebo matched to study drug
Interventions
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Relacorilant
Relacorilant is supplied as 100 mg capsules for oral dosing.
Placebo
Placebo matched to study drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meets at least 1 of the following criteria:
* Has Type 2 diabetes mellitus
* Has impaired glucose tolerance
* Has hypertension.
Exclusion Criteria
* Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
* Has poorly controlled hypertension
* Has poorly controlled diabetes mellitus
* Has severe renal insufficiency.
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 21
Phoenix, Arizona, United States
Site 36
Los Angeles, California, United States
Site 68
Torrance, California, United States
Site 10
Miami, Florida, United States
Site 14
Atlanta, Georgia, United States
Site 41
Chicago, Illinois, United States
Site 7
Indianapolis, Indiana, United States
Site 2
Metairie, Louisiana, United States
Site 45
Baltimore, Maryland, United States
Site 46
Boston, Massachusetts, United States
Site 20
Ann Arbor, Michigan, United States
Site 4
Jackson, Mississippi, United States
Site 13
St Louis, Missouri, United States
Site 53
Omaha, Nebraska, United States
Site 72
Reno, Nevada, United States
Site 8
Albany, New York, United States
Site 6
Jamaica, New York, United States
Site 57
New York, New York, United States
Site 35
New York, New York, United States
Site 39
New York, New York, United States
Site 1
Wilmington, North Carolina, United States
Site 17
Columbus, Ohio, United States
Site 11
Oklahoma City, Oklahoma, United States
Site 62
Philadelphia, Pennsylvania, United States
Site 19
Pittsburgh, Pennsylvania, United States
Site 71
Pittsburgh, Pennsylvania, United States
Site 5
Summerville, South Carolina, United States
Site 51
Dallas, Texas, United States
Site 3
El Paso, Texas, United States
Site 65
Houston, Texas, United States
Site 56
Shavano Park, Texas, United States
Site 31
Everett, Washington, United States
Site 47
Vienna, , Austria
Site 27
Sofia, , Bulgaria
Site 70
Halifax, Nova Scotia, Canada
Site 58
Montreal, , Canada
Site 54
München, , Germany
Site 49
Würzburg, , Germany
Site 30
Jerusalem, , Israel
Site 29
Kfar Saba, , Israel
Site 28
Petah Tikva, , Israel
Site 69
Tel Aviv, , Israel
Site 43
Ancona, , Italy
Site 15
Messina, , Italy
Site 26
Milan, , Italy
Site 12
Napoli, , Italy
Site 38
Orbassano, , Italy
Site 67
Padua, , Italy
Site 40
Roma, , Italy
Site 16
Roma, , Italy
Site 34
Rotterdam, , Netherlands
Site 77
Bialystok, , Poland
Site 37
Chrzanów, , Poland
Site 59
Krakow, , Poland
Site 33
Lublin, , Poland
Site 66
Bucharest, , Romania
Site 63
Bucharest, , Romania
Site 64
Bucharest, , Romania
Site 73
Iași, , Romania
Site 75
Alicante, , Spain
Site 25
Girona, , Spain
Site 24
Madrid, , Spain
Site 22
Málaga, , Spain
Site 23
Seville, , Spain
Countries
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References
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Pivonello R, Munster PN, Terzolo M, Ferrigno R, Simeoli C, Puglisi S, Bali U, Moraitis AG. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant. Front Endocrinol (Lausanne). 2022 Jan 4;12:793262. doi: 10.3389/fendo.2021.793262. eCollection 2021.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CORT125134-455
Identifier Type: -
Identifier Source: org_study_id
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