Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
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
- Atherosclerotic Cardiovascular Disease (ASCVD)
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Pelacarsen |
Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months. |
|
|
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. |
|
Recruiting Locations
Parkway Medical Center
Birmingham 4049979, Alabama 4829764 35215
Birmingham 4049979, Alabama 4829764 35215
Clinical Research Inst of Arizona
Sun City West 5316205, Arizona 5551752 85375
Sun City West 5316205, Arizona 5551752 85375
National Heart Institute
Beverly Hills 5328041, California 5332921 90211
Beverly Hills 5328041, California 5332921 90211
Interv Cardiology Med Grp
West Hills 8030162, California 5332921 91307
West Hills 8030162, California 5332921 91307
Excel Medical Clinical Trials LLC
Boca Raton 4148411, Florida 4155751 33434
Boca Raton 4148411, Florida 4155751 33434
Jacksonville Center for Clinical
Jacksonville 4160021, Florida 4155751 32216
Jacksonville 4160021, Florida 4155751 32216
University of Miami Hospital
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33136
Miami Cancer Institute at Bapt
Miami 4164138, Florida 4155751 33173
Miami 4164138, Florida 4155751 33173
Inpatient Research Clinical LLC
Miami Lakes 4164186, Florida 4155751 33014
Miami Lakes 4164186, Florida 4155751 33014
Inpatient Research Clinical LLC
Miami Lakes 4164186, Florida 4155751 33014
Miami Lakes 4164186, Florida 4155751 33014
FXM Clin Res Miramar LLC
Miramar 4164601, Florida 4155751 33027
Miramar 4164601, Florida 4155751 33027
Ocala Cardiovascular Research
Ocala 4166673, Florida 4155751 34471
Ocala 4166673, Florida 4155751 34471
SEC Clinical Research
Pensacola 4168228, Florida 4155751 32503
Pensacola 4168228, Florida 4155751 32503
Peace River Cardiovascular Center
Port Charlotte 4169130, Florida 4155751 33952
Port Charlotte 4169130, Florida 4155751 33952
FC Site Partners Miami
Winter Park 4178560, Florida 4155751 32789
Winter Park 4178560, Florida 4155751 32789
Advocate Lutheran General Childrens Hospital
Park Ridge 4905367, Illinois 4896861 60068
Park Ridge 4905367, Illinois 4896861 60068
American Health Network Research Dept
Muncie 4924006, Indiana 4921868 47304
Muncie 4924006, Indiana 4921868 47304
American Health Network Research Dept
Muncie 4924006, Indiana 4921868 47304
Muncie 4924006, Indiana 4921868 47304
Cardiovascular Associates Research
Covington 4321005, Louisiana 4331987 70433
Covington 4321005, Louisiana 4331987 70433
Omega Clinical Research
Metairie 4333177, Louisiana 4331987 70006
Metairie 4333177, Louisiana 4331987 70006
Anderson Medical Research
Ft. Washington 4355355, Maryland 4361885 20744
Ft. Washington 4355355, Maryland 4361885 20744
Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202
Detroit 4990729, Michigan 5001836 48202
MyMichigan Medical Center Midland
Midland 5001929, Michigan 5001836 48670
Midland 5001929, Michigan 5001836 48670
AB Clinical Trials
Las Vegas 5506956, Nevada 5509151 89119
Las Vegas 5506956, Nevada 5509151 89119
Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901
Summit 5105127, New Jersey 5101760 07901
Wake Forest University Baptist Medical Center
Winston-Salem 4499612, North Carolina 4482348 27157
Winston-Salem 4499612, North Carolina 4482348 27157
The Corvallis Clinic P C
Corvallis 5720727, Oregon 5744337 97330
Corvallis 5720727, Oregon 5744337 97330
Novartis Investigative Site
Tullahoma 4663494, Tennessee 4662168 37388
Tullahoma 4663494, Tennessee 4662168 37388
PharmaTex Research LLC
Amarillo 5516233, Texas 4736286 79106
Amarillo 5516233, Texas 4736286 79106
Kelsey Seybold Research Foundation
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Northwest Houston Clinical Research PLLC
Tomball 4737094, Texas 4736286 77375
Tomball 4737094, Texas 4736286 77375
Intermountain Medical Center
Murray 5778755, Utah 5549030 84107
Murray 5778755, Utah 5549030 84107
Virginia Heart
Falls Church 4758390, Virginia 6254928 22042
Falls Church 4758390, Virginia 6254928 22042
Latin Clinical Trial Center Inc
San Juan 4568127, Puerto Rico 00909
San Juan 4568127, Puerto Rico 00909
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.