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Purpose

The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male and female participants 18 to ≤80 years of age at Screening visit - Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit - On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit - Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized - On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit - Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit - Central laboratory reported LDL-C >70 mg/dL (or >1.8 mmol/L) at Screening visit

Exclusion Criteria

  • Prior treatment with inclisiran - Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit - Uncontrolled hypertension at Randomization/Baseline visit - Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1) - Triglycerides ≥400 mg/dL at Screening visit - History of malignancy of any organ system within the past 5 years - Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1) - Central laboratory reported platelet count <140,000 per mm3 - Active liver disease or hepatic dysfunction at Screening visit - Significant kidney disease at Screening visit - Pregnant or nursing women at Screening visit - Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit - Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Pelacarsen 		Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months.
  • Drug: Pelacarsen
    Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
    Other names:
    • TQJ230
  • 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.
Placebo Comparator
Placebo 		Participants will be administered placebo subcutaneous injection once monthly for 6 months. After Month 6, all participants will receive pelacarsen 80 mg injection for the remaining 6 months during the open-label treatment period.
  • Drug: Pelacarsen
    Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
    Other names:
    • TQJ230
  • 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.

Recruiting Locations

Parkway Medical Center
Birmingham 4049979, Alabama 4829764 35215
Contact:
Trina Gray
+1 205 815 5000
graytrina1989@gmail.com

Clinical Research Inst of Arizona
Sun City West 5316205, Arizona 5551752 85375
Contact:
Georgina Lopez-Wood
+1 623 223 1580
glopezwood@criofaz.com

National Heart Institute
Beverly Hills 5328041, California 5332921 90211
Contact:
Nayeli Aguillon
+1 301 289 5221
naguillon@nationalheartinstitute.org

Interv Cardiology Med Grp
West Hills 8030162, California 5332921 91307
Contact:
Michael Fam
+1 818 235 7104
mfam@elegantrd.com

Excel Medical Clinical Trials LLC
Boca Raton 4148411, Florida 4155751 33434
Contact:
Joseph Ramsey
+1 561 756 8206
jramsey@flourishresearch.com

Jacksonville Center for Clinical
Jacksonville 4160021, Florida 4155751 32216
Contact:
Theresa Hanburry
+1 904 730 0101
thanburry@encoredocs.com

University of Miami Hospital
Miami 4164138, Florida 4155751 33136
Contact:
Maria Alamanzar
maa3400@miami.edu

Miami Cancer Institute at Bapt
Miami 4164138, Florida 4155751 33173
Contact:
Ruben Dominguez
+1 786 595 8078
Ruben.Dominguez@baptisthealth.net

Inpatient Research Clinical LLC
Miami Lakes 4164186, Florida 4155751 33014
Contact:
Sergio Ramirez
+1 786 502 4303
sramirez@inpatientresearch.com

Inpatient Research Clinical LLC
Miami Lakes 4164186, Florida 4155751 33014
Contact:
Jose Casola
jcasola@inpatientresearch.com

FXM Clin Res Miramar LLC
Miramar 4164601, Florida 4155751 33027
Contact:
Raul Hernandez
+1 208 346 8900
raul@eminat.net

Ocala Cardiovascular Research
Ocala 4166673, Florida 4155751 34471
Contact:
Arleana Brown
arleana.brown@morganmmc.com

SEC Clinical Research
Pensacola 4168228, Florida 4155751 32503
Contact:
Tatum Ramsey
+1 850 696 7148
tramsey@secclinicalresearch.com

Peace River Cardiovascular Center
Port Charlotte 4169130, Florida 4155751 33952
Contact:
Karen Mullinax
+1 941 629 5356
karen@prcvcfl.com

FC Site Partners Miami
Winter Park 4178560, Florida 4155751 32789
Contact:
Dimary Rivera
drivera@flourishresearch.com

Advocate Lutheran General Childrens Hospital
Park Ridge 4905367, Illinois 4896861 60068
Contact:
Marina Kelly
marina.kelly@aah.org

American Health Network Research Dept
Muncie 4924006, Indiana 4921868 47304
Contact:
Stephanie Stewart
+1 765 213 2876
stephanie_stewart@ahni.com

American Health Network Research Dept
Muncie 4924006, Indiana 4921868 47304
Contact:
Gorgi Leigh Avery
+1 765 213 2876
gorgi_avery@ahni.com

Cardiovascular Associates Research
Covington 4321005, Louisiana 4331987 70433
Contact:
Melinda Accardo
+1 985 892 2550
crc3hch@gmail.com

Omega Clinical Research
Metairie 4333177, Louisiana 4331987 70006
Contact:
Tina Messina
+1 504 914 8726
tmessinarn@gmail.com

Anderson Medical Research
Ft. Washington 4355355, Maryland 4361885 20744
Contact:
Ann-Marie Cobb
andersonmedicalresearch@gmail.com

Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202
Contact:
Jodi Carter
+1 313 916 2721
jcarte23@hfhs.org

Aa Mrc Llc
Flint 4992982, Michigan 5001836 48504
Contact:
Fayyaz Shah
fshah@aamrc.net

MyMichigan Medical Center Midland
Midland 5001929, Michigan 5001836 48670
Contact:
Katie Kamyszek
+1 989 631 2469
Katie.kamyszek@mymichigan.org

AB Clinical Trials
Las Vegas 5506956, Nevada 5509151 89119
Contact:
Fungai Siziba-Dubose
+1 702 804 5900
fsdabct@gmail.com

Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901
Contact:
Betty Merveil-Ceneus
betty.merveil-ceneus@atlantichealth.org

Wake Forest University Baptist Medical Center
Winston-Salem 4499612, North Carolina 4482348 27157
Contact:
Keishia Rodriguez
keishia.rodriguez@advocatehealth.org

The Corvallis Clinic P C
Corvallis 5720727, Oregon 5744337 97330
Contact:
Erin Thompson
+1 541 753 1618#1029
erin.thompson@corvallis-clinic.com

Novartis Investigative Site
Tullahoma 4663494, Tennessee 4662168 37388
Contact:
Kayla Nee
+1 931 393 7831
kntcct2@gmail.com

PharmaTex Research LLC
Amarillo 5516233, Texas 4736286 79106
Contact:
Salma Villarreal
+1 806 355 2581
sestradaptx@gmail.com

Kelsey Seybold Research Foundation
Houston 4699066, Texas 4736286 77030
Contact:
Julian Edmonson
+1 713 791 6989
julian.edmonson@kelseyresearch.com

Northwest Houston Clinical Research PLLC
Tomball 4737094, Texas 4736286 77375
Contact:
Dawn Burns
+1 281 351 4911
dburns@houstonheartcenter.com

Intermountain Medical Center
Murray 5778755, Utah 5549030 84107
Contact:
Tyler Winslow
+1 801 507 4777
tyler.winslow@imail.org

Virginia Heart
Falls Church 4758390, Virginia 6254928 22042
Contact:
Deanna Overbeck
+1 703 766 5920
Doverbeck@VirginiaHeart.com

Latin Clinical Trial Center Inc
San Juan 4568127, Puerto Rico 00909
Contact:
Gina Velez
+1 787 249 4763
gvelez@lctcpr.com

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.