| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05763875 | Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. | PHASE3 | COMPLETED | 350 | — | — | Mar 15, 2023 | Jun 20, 2024 | Oct 16, 2025 | 42 | United States, Colombia +3 |
| NCT04765657 | Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C) | PHASE3 | ACTIVE NOT_RECRUITING | 345 | — | — | Mar 1, 2021 | Dec 28, 2026 | Dec 30, 2025 | 45 | China, Singapore +2 |
| NCT04666298 | Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C | PHASE2 | COMPLETED | 312 | — | — | Jan 29, 2021 | Oct 19, 2022 | Jun 20, 2024 | 42 | Japan |
Percentage change in LDL-C from Baseline (day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330
Evaluation of the safety and tolerability of inclisiran, treatment emergent Adverse events and Serious Adverse Events
Percent change from baseline in LDL-C was calculated to evaluate the effect of inclisiran at Day 180. Difference between different inclisiran dose groups and the placebo group in percentage change in LDL-C levels from baseline to Day 180 were calculated to capture both, the effect of the study drug and the effect of additional medications, mirroring the conditions in clinical practice. An MMRM (Mixed-effect Model with Repeated Measurement) was used as the primary analysis model, with treatment group, visits, interaction between visits and treatment groups, current use of statins or other lipid-modifying therapies as fixed effects, and baseline LDL-C as a continuous covariate.
| Arm | Type | Description |
|---|---|---|
| Inclisiran | EXPERIMENTAL | Inclisiran s.c and Placebo p.o |
| Ezetimibe | ACTIVE_COMPARATOR | Placebo s.c. and Ezetimibe p.o. |
| Placebo | PLACEBO_COMPARATOR | Placebo s.c. and Placebo p.o. |
| inclisiran sodium 300 mg | EXPERIMENTAL | Subcutaneous injection |
| 300 mg inclisiran sodium | EXPERIMENTAL | Subcutaneous injection |
| 200 mg inclisiran sodium | EXPERIMENTAL | Subcutaneous injection |
| 100 mg inclisiran sodium | EXPERIMENTAL | Subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Inclisiran | DRUG | 284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90 |
| Ezetimibe | DRUG | 10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149 |
| Matching Placebo for Inclisiran | DRUG | 0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90 |
| Matching Placebo for Ezetimibe | DRUG | 0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149 |
| inclisiran sodium | DRUG | Subcutaneously injected on Day 1, 90 and 270 (Core Part). Subcutaneously injected on Day 360 and every 6 months thereafter until EOS visit (Extension Part) |
| Placebo | DRUG | Subcutaneously injected on Day 1, 90, and 270. |
Inclusion Criteria at screening: * informed consent signed prior to participation in study * fasting LDL-C of \>= 100 mg/dL but \< 190 mg/dL * fasting triglycerides \<= 400 mg/dL * 10-year ASCVD risk score \< 7.5% * not on any lipid-lowering therapy within 90 days of screening Key Exclusion Criter...