Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03697109 | A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome | PHASE3 | COMPLETED | 152 | — | — | Nov 15, 2018 | Apr 15, 2024 | Jul 16, 2025 | 64 | United States, Austria +9 |
| NCT03604198 | Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | PHASE2 | ACTIVE NOT_RECRUITING | 125 | — | — | May 7, 2018 | Dec 1, 2026 | Apr 21, 2026 | 48 | United States, Austria +8 |
| NCT05347979 | Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Participants | PHASE1 | COMPLETED | 30 | — | — | May 25, 2022 | Jul 19, 2022 | Feb 9, 2023 | 1 | United States |
Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason.
Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0
| Arm | Type | Description |
|---|---|---|
| Relacorilant (OL Phase) | EXPERIMENTAL | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. |
| Relacorilant (RW Phase) | EXPERIMENTAL | 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. |
| Placebo (RW Phase) | PLACEBO_COMPARATOR | Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. |
| relacorilant (CORT125134) | EXPERIMENTAL | - |
| Dabigatran Etexilate (NIMP) and Relacorilant (IMP) | EXPERIMENTAL | Following an overnight fast, participants will receive 75 mg dabigatran etexilate on Day 1, 400 mg dose of relacorilant QD on Days 3 to 13, and 75 mg dabigatran etexilate on Day 12. On Day 12, dabigatran etexilate will be dosed at approximately the same time as the relacorilant dose. |
| Name | Type | Description |
|---|---|---|
| Relacorilant | DRUG | Relacorilant is supplied as 100 mg capsules for oral dosing. |
| Placebo | OTHER | Placebo matched to study drug |
| Dabigatran Etexilate | DRUG | Dabigatran will be administered orally as a 75 mg capsule on Day 1 and Day 12. |
Inclusion Criteria: * Has a confirmed diagnosis of endogenous Cushing syndrome * Meets at least 1 of the following criteria: * Has Type 2 diabetes mellitus * Has impaired glucose tolerance * Has hypertension. Exclusion Criteria: * Has non-endogenous source of hypercortisolism * Has uncontr...