Hypercortisolism Clinical Trial
— GRADIENTOfficial 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
Verified date | June 2024 |
Source | Corcept Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Corcept Therapeutics |
United States, Austria, Bulgaria, Germany, Israel, Italy, Poland, Romania, Spain,
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 |
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