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, Alabama 35215
Birmingham, Alabama 35215
Clinical Research Inst of Arizona
Sun City West, Arizona 85375
Sun City West, Arizona 85375
National Heart Institute
Beverly Hills, California 90211
Beverly Hills, California 90211
Interv Cardiology Med Grp
West Hills, California 91307
West Hills, California 91307
Excel Medical Clinical Trials LLC
Boca Raton, Florida 33434
Boca Raton, Florida 33434
Jacksonville Center for Clinical
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Baptist Health South
Miami, Florida 33173
Miami, Florida 33173
Inpatient Research Clinical LLC
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
Inpatient Research Clinical LLC
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
FXM Clin Res Miramar LLC
Miramar, Florida 33027
Miramar, Florida 33027
Ocala Cardiovascular Research
Ocala, Florida 34471
Ocala, Florida 34471
SEC Clinical Research
Pensacola, Florida 32503
Pensacola, Florida 32503
Peace River Cardiovascular Center
Port Charlotte, Florida 33952
Port Charlotte, Florida 33952
FC Site Partners Miami
Winter Park, Florida 32789
Winter Park, Florida 32789
Advocate Lutheran General Childrens Hospital
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
American Health Network Research Dept
Muncie, Indiana 47304
Muncie, Indiana 47304
American Health Network Research Dept
Muncie, Indiana 47304
Muncie, Indiana 47304
Cardiovascular Associates Research
Covington, Louisiana 70433
Covington, Louisiana 70433
Omega Clinical Research
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Anderson Medical Research
Ft. Washington, Maryland 20744
Ft. Washington, Maryland 20744
MyMichigan Medical Center Midland
Midland, Michigan 48670
Midland, Michigan 48670
AB Clinical Trials
Las Vegas, Nevada 89119
Las Vegas, Nevada 89119
Overlook Medical Center
Summit, New Jersey 07901
Summit, New Jersey 07901
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
The Corvallis Clinic P C
Corvallis, Oregon 97330
Corvallis, Oregon 97330
Novartis Investigative Site
Tullahoma, Tennessee 37388
Tullahoma, Tennessee 37388
PharmaTex Research LLC
Amarillo, Texas 79106
Amarillo, Texas 79106
Kelsey Seybold Research Foundation
Houston, Texas 77030
Houston, Texas 77030
Northwest Houston Clinical Research PLLC
Tomball, Texas 77375
Tomball, Texas 77375
Intermountain Medical Center
Murray, Utah 84107
Murray, Utah 84107
Virginia Heart
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Latin Clinical Trial Center Inc
San Juan, Puerto Rico 00909
San Juan, 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.