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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07034768 | A Study to Evaluate EDG-7500 in People With Renal Impairment | PHASE1 | COMPLETED | 37 | — | — | Jul 22, 2025 | Dec 26, 2025 | Mar 12, 2026 | 2 | United States |
Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-last)
Area under the plasma concentration time-curve from zero to extrapolated infinite time (AUC0-inf)
The time measured for the plasma concentration to decrease by one half.
| Arm | Type | Description |
|---|---|---|
| Healthy Volunteers | EXPERIMENTAL | - |
| Severe Renal Impairment | EXPERIMENTAL | - |
| Moderate Renal Impairment | EXPERIMENTAL | - |
| Mild Renal Impairment | EXPERIMENTAL | This arm will only be conducted if deemed necessary based on data in participants with moderate and severe renal impairment |
| Name | Type | Description |
|---|---|---|
| EDG-7500 | DRUG | Single dose of EDG-7500 |
Key Inclusion Criteria: All Participants * Adult, male or female, 18-75 years of age, inclusive * Female and male participants must follow protocol-specified contraception guidance * Continuous non-smoker or light smoker (≤ 5 cigarettes per day or equivalent) for at least 3 months prior to dosing ...