Pelacarsen

Generic Name: Pelacarsen

Drug Type: Biotech

CAS Number: 1637637-70-7

Unique Ingredient Identifier: LSO9H7UZ90

Background: Pelacarsen is under investigation in clinical trial NCT03070782 (Phase 2 Study of ISIS 681257 (Akcea-apo(a)-lrx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease).

Clinical Trials

Pelacarsen Roll-over Extension Program

Phase 3

Not yet recruiting

Conditions: Atherosclerotic Cardiovascular Disease

Interventions: Drug: Pelacarsen (TQJ230)

First Posted Date: 2025-03-14

Last Posted Date: 2025-03-25

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 600

Registration Number: NCT06875973

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

Phase 3

Not yet recruiting

Conditions: Atherosclerotic Cardiovascular Disease (ASCVD)

Interventions: Drug: Pelacarsen
Drug: Inclisiran
Drug: Placebo

First Posted Date: 2025-02-07

Last Posted Date: 2025-04-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 340

Registration Number: NCT06813911

Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD

Phase 3

Recruiting

Conditions: Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

Interventions: Drug: TQJ230
Drug: Placebo

First Posted Date: 2024-02-20

Last Posted Date: 2025-03-19

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 400

Registration Number: NCT06267560

Locations: 🇺🇸
Synexus Clinical Research Advantage, Birmingham, Alabama, United States
🇺🇸
Parkway Medical Center, Birmingham, Alabama, United States
🇺🇸
Optimal Research LLC, Huntsville, Alabama, United States

and more 97 locations

An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Phase 3

Active, not recruiting

Conditions: Hyperlipoproteinemia (a)

Interventions: Drug: Pelacarsen

First Posted Date: 2023-06-12

Last Posted Date: 2025-04-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 41

Registration Number: NCT05900141

Locations: 🇩🇪
Novartis Investigative Site, Wuerzburg, Germany

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Phase 2

Recruiting

Conditions: Aortic Stenosis

Interventions: Drug: Pelacarsen (TQJ230) 80mg
Drug: Matching placebo

First Posted Date: 2022-12-12

Last Posted Date: 2025-05-04

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 502

Registration Number: NCT05646381

Locations: 🇺🇸
Heart Center Research Llc, Huntsville, Alabama, United States
🇺🇸
Cardiovascular Res Found, Beverly Hills, California, United States
🇺🇸
National Heart Institute, Beverly Hills, California, United States

and more 26 locations

A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Placebo
Drug: Pelacarsen

First Posted Date: 2022-04-20

Last Posted Date: 2022-04-20

Lead Sponsor: Ionis Pharmaceuticals, Inc.

Target Recruit Count: 29

Registration Number: NCT05337878

Locations: 🇺🇸
Parexel International, Glendale, California, United States

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

Phase 3

Completed

Conditions: Hyperlipoproteinemia(a)

Interventions: Drug: Pelacarsen (TQJ230) 80 mg s.c.
Drug: Corresponding Placebo

First Posted Date: 2022-03-31

Last Posted Date: 2025-02-14

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 51

Registration Number: NCT05305664

Locations: 🇩🇪
Novartis Investigative Site, Wuerzburg, Germany

Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: Pelacarsen

First Posted Date: 2021-08-30

Last Posted Date: 2024-10-09

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 17

Registration Number: NCT05026996

Locations: 🇺🇸
Novartis Investigative Site, San Antonio, Texas, United States

Influence of Pelacarsen on Patients After Myocardial Infarction With High Lp(a) Values (PEMILA)

Not Applicable

Withdrawn

Conditions: Acute Coronary Syndrome
Inflammation
Genetic Polymorphisms
Lipoproteinemia

Interventions: Drug: Pelacarsen (TQJ230)
Drug: Placebo

First Posted Date: 2021-08-06

Last Posted Date: 2022-01-03

Lead Sponsor: University Medical Centre Ljubljana

Registration Number: NCT04993664

Locations: 🇸🇮
University Medical Centre Ljubljana-Department of Vascular diseases and dept. of Cardiology, Ljubljana, Slovenia

Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

Phase 3

Active, not recruiting

Conditions: Cardiovascular Disease and Lipoprotein(a)

Interventions: Drug: Placebo
Drug: TQJ230

First Posted Date: 2019-07-17

Last Posted Date: 2025-03-14

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 8323

Registration Number: NCT04023552

Locations: 🇺🇸
SEC Clinical Research LLC, Andalusia, Alabama, United States
🇬🇧
Novartis Investigative Site, Wrexham, United Kingdom
🇺🇸
Mercy Gilbert Medical Center, Gilbert, Arizona, United States

and more 29 locations

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