5 completed, 4 active not recruiting, 2 withdrawn, 1 no longer available. 7 Phase 3, 2 Phase 1, 2 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Active not recruiting 4, Completed 2, Withdrawn 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Completed 1, Recruiting 1 |
| Not applicable | 1 | Withdrawn 1 |
Follow pelacarsen: new trials by email Literature Review of pelacarsen trials Research Report on pelacarsen
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL Pelacarsen, Placebo - Acute Coronary Syndrome (ACS) | Phase 3 | Withdrawn | Novartis Pharmaceuticals | 2026-09-01 | 2026-10-14 | |
| An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) Pelacarsen (TQJ230) - Cardiovascular Disease and Lipoprotein(a) | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 5700 | 2026-05-11 | 2026-10-14 |
| Pelacarsen Roll-over Extension Program Pelacarsen (TQJ230) - Atherosclerotic Cardiovascular Disease | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 599 | 2025-05-19 | 2026-10-14 |
| Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD Pelacarsen, Placebo, Inclisiran - Atherosclerotic Cardiovascular Disease (ASCVD) | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 246 | 2025-04-30 | 2026-10-14 |
| Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD TQJ230, Placebo - Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease | Phase 3 | Completed | Novartis Pharmaceuticals | 422 | 2024-04-24 | 2026-08-10 |
| A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis Pelacarsen (TQJ230) 80mg, Matching placebo - Aortic Stenosis | Phase 2 | Recruiting | Novartis Pharmaceuticals | 502 | 2024-03-07 | 2026-06-23 |
| An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) Pelacarsen - Hyperlipoproteinemia (a) | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 41 | 2023-09-29 | 2026-10-14 |
| A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany Pelacarsen (TQJ230) 80 mg s.c., Corresponding Placebo - Hyperlipoproteinemia(a) | Phase 3 | Completed | Novartis Pharmaceuticals | 51 | 2022-08-19 | 2026-07-17 |
| Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants Pelacarsen - Hepatic Impairment | Phase 1 | Completed | Novartis Pharmaceuticals | 17 | 2021-11-23 | 2024-10-09 |
| Influence of Pelacarsen on Patients After Myocardial Infarction With High Lp(a) Values (PEMILA) Pelacarsen (TQJ230), Placebo - Acute Coronary Syndrome, Lipoproteinemia | Not applicable | Withdrawn | University Medical Centre Ljubljana | 2021-10-01 | 2022-01-03 | |
| A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants Placebo, Pelacarsen - Healthy Participants | Phase 1 | Completed | Ionis Pharmaceuticals, Inc. | 29 | 2018-10-15 | 2022-04-20 |
| Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease ISIS 681257, Placebo - Elevated Lipoprotein(a), Cardiovascular Disease | Phase 2 | Completed | Akcea Therapeutics | 286 | 2017-03-07 | 2020-10-30 |
| Managed Access Programs for TQJ230, Pelacarsen Pelacarsen - Atherosclerotic Cardiovascular Disease, ASCVD | No longer available | Novartis Pharmaceuticals | 2026-10-20 |
Cardiovascular Diseases (6) · Atherosclerosis (3) · Acute Coronary Syndrome (2) · Dyslipidemias (2) · Hyperlipoproteinemias (2) · Aortic Valve Stenosis (1) · Coronary Disease (1) · Hyperlipidemias (1) · Inflammation (1) · Myocardial Infarction (1) · Non-ST Elevated Myocardial Infarction (1) · ST Elevation Myocardial Infarction (1) · Stroke (1)
Novartis Pharmaceuticals (10) · Akcea Therapeutics (1) · Ionis Pharmaceuticals, Inc. (1) · University Medical Centre Ljubljana (1)
United States (8) · Germany (6) · Netherlands (4) · Puerto Rico (4) · Canada (3) · Denmark (3) · France (3) · Italy (3) · Spain (3) · United Kingdom (3) · Austria (2) · Belgium (2) · China (2) · Czechia (2) · Hong Kong (2)
PMID 37070852, PMID 31893580, PMID 32268367, PMID 39329200, PMID 39331470, PMID 41021771, PMID 41721795, PMID 42592935
2016 (1), 2023 (1)