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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07619118 | A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia | PHASE3 | NOT YET_RECRUITING | 200 | — | — | Sep 15, 2026 | May 28, 2027 | Jun 1, 2026 | - | — |
| NCT07619131 | A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients. | PHASE3 | NOT YET_RECRUITING | 600 | — | — | Aug 17, 2026 | Jul 30, 2027 | Jun 1, 2026 | - | — |
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks
| Arm | Type | Description |
|---|---|---|
| laroprovstat/rosuvastatin dose 1 | EXPERIMENTAL | Patient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1 |
| rosuvastatin dose 1 | ACTIVE_COMPARATOR | Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1 |
| laroprovstat/rosuvastatin dose 2 | EXPERIMENTAL | Patient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2 |
| rosuvastatin dose 2 | ACTIVE_COMPARATOR | Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2 |
| laroprovstat/rosuvastatin dose 3 | EXPERIMENTAL | Patient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3 |
| rosuvastatin dose 3 | ACTIVE_COMPARATOR | Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3 |
| laroprovstat/rosuvastatin dose 4 | EXPERIMENTAL | Patient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4 |
| rosuvastatin dose 4 | ACTIVE_COMPARATOR | Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4 |
| Laroprovstat | ACTIVE_COMPARATOR | The patient will receive a daily dose of Laroprovstat |
| Placebo | PLACEBO_COMPARATOR | The patient will receive a daily dose of Placebo |
| Laroprovstat/Rosuvastatin dose combination 1 | EXPERIMENTAL | The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1 |
| Laroprovstat/Rosuvastatin dose combination 2 | EXPERIMENTAL | The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2 |
| Name | Type | Description |
|---|---|---|
| laroprovstat/rosuvastatin 1 | COMBINATION_PRODUCT | daily oral dose of the laroprovstat/rosuvastatin 1 |
| laroprovstat/rosuvastatin 2 | COMBINATION_PRODUCT | daily oral dose of the laroprovstat/rosuvastatin 2 |
| laroprovstat/rosuvastatin 3 | COMBINATION_PRODUCT | daily oral dose of the laroprovstat/rosuvastatin 3 |
| laroprovstat/rosuvastatin 4 | COMBINATION_PRODUCT | daily oral dose of the laroprovstat/rosuvastatin 4 |
| Placebo to match laroprovstat/rosuvastatin 1,2,3 | DRUG | Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3 |
| Placebo to match laroprovstat/rosuvastatin 4 | DRUG | Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4 |
| Rosuvastatin 1 | DRUG | daily oral dose of rosuvastatin 1 |
| Rosuvastatin 2 | DRUG | daily oral dose of rosuvastatin 2 |
| Rosuvastatin 3 | DRUG | daily oral dose of rosuvastatin 3 |
| Rosuvastatin 4 | DRUG | daily oral dose of rosuvastatin 4 |
| Placebo to match Rosuvastatin | DRUG | daily oral dose of placebo to match rosuvastatin |
| Laroprovstat | DRUG | daily oral dose of the Laroprovstat |
| Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 | DRUG | daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 |
| Placebo to match Laroprovstat/Rosuvastatin 2 | DRUG | daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2 |
Inclusion Criteria: * Participant must be ≥ 18 years of age * Participants must be on a stable dose of all background LLTs * The stable statin dose should be judged as their maximally tolerated dose * Participants should have either history of a clinical ASCVD event or be at increased risk for a fi...