NCT06813911 - Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD | Biotech Hunter

Enrollment

340

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

November 5, 2027

Study Completion Date

December 1, 2027

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)

Interventions

DRUG

Pelacarsen

Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.

DRUG

Placebo

Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.

DRUG

Inclisiran

All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11.

Trial Locations (30)

11217

RECRUITING

Novartis Investigative Site, Taipei

20744

RECRUITING

Anderson Medical Research, Ft. Washington

22042

RECRUITING

Virginia Heart, Falls Church

32216

RECRUITING

Jacksonville Center for Clinical, Jacksonville

32789

RECRUITING

FC Site Partners Miami, Winter Park

33014

RECRUITING

Inpatient Research Clinical LLC, Miami Lakes

RECRUITING

Inpatient Research Clinical LLC, Miami Lakes

33027

RECRUITING

Eminat LLC, Miramar

33136

RECRUITING

University of Miami Hospital, Miami

33434

RECRUITING

Excel Medical Clinical Trials LLC, Boca Raton

37388

RECRUITING

Novartis Investigative Site, Tullahoma

48202

RECRUITING

Henry Ford Hospital, Detroit

48504

RECRUITING

Aa Mrc Llc, Flint

48670

RECRUITING

MyMichigan Medical Center Midland, Midland

70006

RECRUITING

Omega Clinical Research, Metairie

70433

RECRUITING

Cardiovascular Associates Research, Covington

77375

RECRUITING

Northwest Houston Clinical Research PLLC, Tomball

85375

RECRUITING

Clinical Research Inst of Arizona, Sun City West

89119

RECRUITING

AB Clinical Trials, Las Vegas

90211

RECRUITING

National Heart Institute, Beverly Hills

100039

RECRUITING

Novartis Investigative Site, Yinchuan

100730

RECRUITING

Novartis Investigative Site, Beijing

200025

RECRUITING

Novartis Investigative Site, Shanghai

272000

RECRUITING

Novartis Investigative Site, Jining

710061

RECRUITING

Novartis Investigative Site, Xian

999077

RECRUITING

Novartis Investigative Site, Pokfulam

791064165

RECRUITING

PharmaTex Research LLC, Amarillo

07901

RECRUITING

Overlook Medical Center, Summit

00909

RECRUITING

Latin Clinical Trial Center Inc, San Juan

W12 0HS

RECRUITING

Novartis Investigative Site, London