Table 1 Summary of ORION and VICTORION programs
Trial | Phase | Description | Population | Participants | Country | Status |
|---|---|---|---|---|---|---|
ORION-1 (NCT02597127) | II | Efficacy and Safety in different doings | ASCVD or risk equivalent | 501 | Multi-countries | Completed |
ORION-2 (NCT02963311) | II | Efficacy and safety in HoFH | HoFH | 9 | Multi-countries | Completed |
ORION-3 (NCT03060577) | II | Open-label extension study of ORION-1 | ASCVD or risk equivalent | 382 | Multi-countries | Completed |
ORION-4 (NCT03705234) | III | Cardiovascular outcome study | ASCVD | 15,000 | UK, US | On going |
ORION-5 (NCT03851705) | III | Efficacy and safety in HoFH | HoFH | 56 | Multi-countries | Completed |
ORION-6 | I | Hepatic pharmacokinetics | Hepatic impairment | 24 | US | Completed |
ORION-7 (NCT03159416) | I | Renal pharmacokinetics | Renal impairment | 31 | US | Completed |
ORION-8 (NCT03814187) | III | Long term extension study of ORION-3/9/10/11 | ASCVD or risk equivalent, FH | 3275 | Multi-countries | On going |
ORION-9 (NCT03397121) | III | Efficacy and safety in HeFH | HeFH | 482 | Multi-countries | Completed |
ORION-10 (NCT03399370) | III | Efficacy and safety in US | ASCVD | 1561 | US | Completed |
ORION-11 (NCT03400800) | III | Efficacy and safety in EU | ASCVD or risk equivalent | 1617 | Multi-countries | Completed |
ORION-12 | I | Thorough QT/QTc | Healthy volunteers | 48 | US | Completed |
ORION-13 (NCT04659863) | III | Efficacy and safety in HoFH adolescents | Adolescents with HoFH | 12 | Multi-countries | On going |
ORION-14 (NCT04774003) | I | Efficacy and safety in Chinese | Chinese | 40 | China | Completed |
ORION-15 (NCT04666298) | II | Efficacy and safety in Japanese | Japanese with ASCVD | 312 | Japan | Completed |
ORION-16 (NCT04652726) | III | Efficacy and safety in HeFH adolescents | Adolescents with HeFH | 150 | Multi-countries | On going |
ORION-17 | III | Primary prevention trial | – | 40,000 | UK | In planning |
ORION-18 (NCT04765657) | III | Efficacy and safety in Asian | ASCVD or risk equivalent | 345 | Asia | On going |
VICTORION-INCEPTION (NCT04873934) | III | Inclisiran vs. usual care | Recent ACS | 384 | US | On going |
VICTORION-2PREVENT (NCT05030428) | III | MACE | ASCVD | 15,000 | Multi-countries | On going |
VICTORION-INICIATE (NCT04929249) | III | Inclisiran first vs. usual care | ASCVD | 444 | US | On going |
VICTORION-IMPLEMENT (NCT05362903) | – | Inclisiran prospective cohort | Elevated LDL-C | 2030 | Germany | On going |
VICTORION-REAL (NCT05399992) | – | Efficacy and adherence prospective cohort | ASCVD or risk equivalent or HeFH | 2100 | Switzerland | On going |
V-DIFERENCE (NCT05192941) | IV | Efficacy, safety and quality of life | ASCVD or risk equivalent or HeFH | 1,760 | EU | On going |
VICTORION-SPIRIT (NCT04807400) | III | Implementation, preference and utility for administration | ASCVD or risk equivalent | 898 | UK | On going |