Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Laroprovstat
laroprovstat/rosuvastatin 1 · 2 trials · 1 indication
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...
Laroprovstat/ezetimibe FCDP is an investigational fixed-combination drug product being studied for use in hypercholesterolaemia and in healthy participants. It combines laroprovstat with ezetimibe, and clinical development includes a Phase 1 bioavailability study in healthy adults.
Laroprovstat/ezetimibe FCDP is a small molecule combination product. Its components include laroprovstat and ezetimibe, and it is being evaluated for its effect on LDL-C in patients with hypercholesterolaemia.
Laroprovstat/ezetimibe FCDP is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials of this fixed-combination drug product in hypercholesterolaemia and in healthy participants.
Laroprovstat/ezetimibe FCDP is in Phase 1 clinical development. A Phase 1 crossover study is active but not recruiting participants, and it is not yet approved by regulatory authorities.
Laroprovstat/ezetimibe FCDP is involved in three trials. NCT07622433 is a Phase 1 bioavailability study in healthy adults. NCT07619118 and NCT07619131 are Phase 3 studies in hypercholesterolaemia, though they have not yet started recruiting.
Laroprovstat/ezetimibe FCDP is also known as laroprovstat/rosuvastatin 1 and Laroprovstat. It is a fixed-combination drug product that pairs laroprovstat with ezetimibe, and it is being studied alongside rosuvastatin in some trials.