ISIS 678354
Sponsors
Ionis Pharmaceuticals Inc., Akcea Therapeutics
Conditions
AtherosclerosisCardiovascular DiseasesFamilial Chylomicronemia SyndromeFamilial Chylomicronemia Syndrome (FCS)HypertriglyceridemiaSevere Hypertriglyceridemia (SHTG)Severe Hypertriglyceridemia.Severe hypertryglyceridemia
Phase 2
Phase 3
ISIS 678354-CS6 A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia
CompletedCTIS2022-501420-20-00
Start: 2023-05-17End: 2025-09-12Target: 248Updated: 2025-09-03
ISIS 678354-CS9: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients with Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or with Severe Hypertriglyceridemia
CompletedCTIS2022-503022-13-00
Start: 2023-06-08End: 2025-05-30Target: 577Updated: 2025-04-16
An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia (SHTG)
Active, not recruitingCTIS2022-501999-26-00
Start: 2023-07-12Target: 502Updated: 2025-12-19
ISIS 678354-CS7: An Open-Label Study of AKCEA-APOCIII-LRX Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen (ISIS 304801)
RecruitingCTIS2023-508815-22-00
Start: 2022-02-25Target: 1Updated: 2025-08-21
ISIS 678354-CS5: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients with Severe Hypertriglyceridemia.
CompletedCTIS2024-510696-38-00
Start: 2022-03-08End: 2025-05-28Target: 368Updated: 2025-06-30
ISIS 678354-CS13: An Open-Label Extension Study of AKCEA-APOCIII-LRX Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS)
Active, not recruitingCTIS2023-509029-29-00
Start: 2022-06-29Target: 30Updated: 2025-06-26