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Also known as Laroprovstat STP, Laroprovstat Dose X STP
Laroprovstat · 4 trials · 2 indications
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2)
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2).
| 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 |
| Treatment A | EXPERIMENTAL | Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state. |
| Treatment B | EXPERIMENTAL | Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state. |
| Treatment C | EXPERIMENTAL | Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state. |
| Treatment D | EXPERIMENTAL | Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state. |
| Cohort 1 Treatment A | EXPERIMENTAL | Participants will receive a single oral Fixed Combination Drug Product (FCDP) test formulation 1 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast. |
| Cohort 1 Treatment B | EXPERIMENTAL | Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast. |
| Cohort 1 Treatment C | EXPERIMENTAL | Participants will receive a single oral Dose X laroprovstat and a single oral Dose 1 rosuvastatin as Single Therapy Product (STP) reference formulations following an overnight fast. |
| Cohort 2 Treatment D | EXPERIMENTAL | Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast. |
| Cohort 2 Treatment E | EXPERIMENTAL | Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast. |
| Cohort 2 Treatment F | EXPERIMENTAL | Participants will receive a single oral Dose X laroprovstat and a single oral Dose 2 rosuvastatin as STP reference formulations following an overnight fast. |
| Cohort 2 Treatment G | EXPERIMENTAL | Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin in a fed state. |
| 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 |
| Laroprovstat/ezetimibe FCDP | DRUG | Laroprovstat/ezetimibe will be administered orally. |
| Laroprovstat STP | DRUG | Laroprovstat will be administered orally. |
| Ezetimibe STP | DRUG | Ezetimibe will be administered orally. |
| Laroprovstat/ezetimibe FCDP-slow variant | DRUG | Laroprovstat/ezetimibe slow variant will be administered orally |
| Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 | DRUG | Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 | DRUG | Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 | DRUG | Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 | DRUG | Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Laroprovstat Dose X STP | DRUG | Laroprovstat Dose X STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Rosuvastatin Dose 1 STP | DRUG | Rosuvastatin Dose 1 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Rosuvastatin Dose 2 STP | DRUG | Rosuvastatin Dose 2 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
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 developed by AstraZeneca PLC. It combines laroprovstat with ezetimibe in a single fixed-dose formulation. It is a small molecule therapy under study in healthy participants and in patients with hypercholesterolaemia, and it has not been approved for any use.
Laroprovstat/ezetimibe FCDP is being studied for hypercholesterolaemia, a condition of elevated cholesterol, and in healthy participants for bioavailability assessment. The hypercholesterolaemia program includes Phase III studies measuring effects on LDL-C in patients who are lipid-lowering therapy naive and in patients with hypercholesterolaemia.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of laroprovstat/ezetimibe FCDP. The company is running the clinical program for the fixed combination, including a Phase I relative bioavailability study in healthy adults and Phase III studies in patients with hypercholesterolaemia.
Laroprovstat/ezetimibe FCDP is in Phase 1 development overall, with Phase III studies also listed for the program. It is investigational and has not been approved by the FDA. Two trials are active, and no completed trials are recorded for this asset.
The program includes NCT07622433, a Phase I crossover study comparing the relative bioavailability of laroprovstat plus ezetimibe fixed combination products versus the single therapies in healthy adults, and NCT07619131, a Phase III study of FDC laroprovstat/rosuvastatin versus laroprovstat, rosuvastatin and placebo on LDL-C in lipid-lowering therapy naive patients.
Laroprovstat/ezetimibe FCDP is a fixed combination product that contains laroprovstat, and laroprovstat is also studied on its own and in a separate fixed combination with rosuvastatin. The names laroprovstat/rosuvastatin 1 and laroprovstat refer to related but distinct presentations within the same AstraZeneca development program.