Actively Recruiting
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Led by Novartis Pharmaceuticals · Updated on 2026-05-13
340
Participants Needed
96
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants 18 to 60 years of age at Screening visit
- Established atherosclerotic cardiovascular disease (ASCVD), including coronary heart disease, cerebrovascular disease, or peripheral arterial disease
- On stable doses of locally recommended lipid-lowering therapy for at least 30 days before Screening visit
- Successful completion of the run-in period with background inclisiran treatment
- On standard care for other cardiovascular risk factors, including hypertension and diabetes, for at least 30 days before Randomization/Baseline visit
- Central laboratory measured lipoprotein(a) level of 175 nmol/L or higher at Screening visit
- Central laboratory measured LDL-C level greater than 70 mg/dL (or 1.8 mmol/L) at Screening visit
You will not qualify if you...
- Prior treatment with inclisiran
- Use of any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) within 4 months before Screening visit
- Uncontrolled hypertension at Randomization/Baseline visit
- Heart failure classified as New York Heart Association (NYHA) class IV at Screening or Randomization/Baseline visit
- Triglyceride levels of 400 mg/dL or higher at Screening visit
- History of cancer of any organ system within the past 5 years
- Major cardiac or non-cardiac surgery, myocardial infarction, stroke, major bleeding, or coronary/lower limb revascularization between Screening and Randomization/Baseline visit
- Platelet count below 140,000 per mm3
- Active liver disease or liver dysfunction at Screening visit
- Significant kidney disease at Screening visit
- Pregnancy or nursing at Screening visit
- Any uncontrolled chronic or serious medical condition posing immediate risk to clinical stability at Screening visit
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 96 locations
1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
Actively Recruiting
2
Clinical Research Inst of Arizona
Sun City West, Arizona, United States, 85375
Actively Recruiting
3
National Heart Institute
Beverly Hills, California, United States, 90211
Actively Recruiting
4
Interv Cardiology Med Grp
West Hills, California, United States, 91307
Actively Recruiting
5
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States, 33434
Actively Recruiting
6
Jacksonville Center for Clinical
Jacksonville, Florida, United States, 32216
Actively Recruiting
7
K2 Medical Research LLC
Maitland, Florida, United States, 32751
Actively Recruiting
8
University of Miami Hospital
Miami, Florida, United States, 33136
Actively Recruiting
9
Baptist Health South
Miami, Florida, United States, 33173
Actively Recruiting
10
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States, 33014
Actively Recruiting
11
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States, 33014
Actively Recruiting
12
FXM Clin Res Miramar LLC
Miramar, Florida, United States, 33027
Actively Recruiting
13
Ocala Cardiovascular Research
Ocala, Florida, United States, 34471
Actively Recruiting
14
SEC Clinical Research
Pensacola, Florida, United States, 32503
Actively Recruiting
15
Peace River Cardiovascular Center
Port Charlotte, Florida, United States, 33952
Actively Recruiting
16
University Of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
17
FC Site Partners Miami
Winter Park, Florida, United States, 32789
Actively Recruiting
18
Advocate Lutheran General Childrens Hospital
Park Ridge, Illinois, United States, 60068
Actively Recruiting
19
American Health Network Research Dept
Muncie, Indiana, United States, 47304
Actively Recruiting
20
American Health Network Research Dept
Muncie, Indiana, United States, 47304
Actively Recruiting
21
Cardiovascular Associates Research
Covington, Louisiana, United States, 70433
Actively Recruiting
22
Omega Clinical Research
Metairie, Louisiana, United States, 70006
Actively Recruiting
23
Flourish Research Bowie
Bowie, Maryland, United States, 20715
Actively Recruiting
24
Anderson Medical Research
Ft. Washington, Maryland, United States, 20744
Actively Recruiting
25
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
26
Aa Mrc Llc
Flint, Michigan, United States, 48504
Actively Recruiting
27
MyMichigan Medical Center Midland
Midland, Michigan, United States, 48670
Actively Recruiting
28
AB Clinical Trials
Las Vegas, Nevada, United States, 89119
Actively Recruiting
29
Overlook Medical Center
Summit, New Jersey, United States, 07901
Actively Recruiting
30
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
31
The Corvallis Clinic P C
Corvallis, Oregon, United States, 97330
Actively Recruiting
32
Novartis Investigative Site
Tullahoma, Tennessee, United States, 37388
Actively Recruiting
33
PharmaTex Research LLC
Amarillo, Texas, United States, 79106
Actively Recruiting
34
Kelsey Seybold Research Foundation
Houston, Texas, United States, 77030
Actively Recruiting
35
Northwest Houston Clinical Research PLLC
Tomball, Texas, United States, 77375
Actively Recruiting
36
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
37
Virginia Heart
Falls Church, Virginia, United States, 22042
Actively Recruiting
38
Novartis Investigative Site
Yinchuan, Ningxia, China, 750004
Active, Not Recruiting
39
Novartis Investigative Site
Jining, Shandong, China, 272000
Actively Recruiting
40
Novartis Investigative Site
Xian, Shanxi, China, 710061
Actively Recruiting
41
Novartis Investigative Site
Beijing, China, 100730
Actively Recruiting
42
Novartis Investigative Site
Shanghai, China, 200025
Actively Recruiting
43
Novartis Investigative Site
Béziers, France, 34525
Actively Recruiting
44
Novartis Investigative Site
Cholet, France, 49325
Actively Recruiting
45
Novartis Investigative Site
Grenoble, France, 38043
Actively Recruiting
46
Novartis Investigative Site
Lille, France, 59037
Actively Recruiting
47
Novartis Investigative Site
Montpellier, France, 34295
Actively Recruiting
48
Novartis Investigative Site
Paris, France, 75013
Actively Recruiting
49
Novartis Investigative Site
Pessac, France, 33604
Actively Recruiting
50
Novartis Investigative Site
Poitiers, France, 86021
Actively Recruiting
51
Novartis Investigative Site
Toulouse, France, 31054
Actively Recruiting
52
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany, 70376
Actively Recruiting
53
Novartis Investigative Site
Potsdam, Brandenburg, Germany, 14473
Actively Recruiting
54
Novartis Investigative Site
Chemnitz, Saxony, Germany, 09113
Actively Recruiting
55
Novartis Investigative Site
Leipzig, Saxony, Germany, 04103
Actively Recruiting
56
Novartis Investigative Site
Berlin, Germany, 10789
Actively Recruiting
57
Novartis Investigative Site
Bielefeld, Germany, 33604
Actively Recruiting
58
Novartis Investigative Site
Gelnhausen, Germany, 63571
Actively Recruiting
59
Novartis Investigative Site
Mannheim, Germany, 68165
Actively Recruiting
60
Novartis Investigative Site
Münster, Germany, 48145
Actively Recruiting
61
Novartis Investigative Site
Singen, Germany, 78224
Actively Recruiting
62
Novartis Investigative Site
Hong Kong, Hong Kong, Hong Kong, 999077
Actively Recruiting
63
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Actively Recruiting
64
Novartis Investigative Site
Ancona, AN, Italy, 60126
Actively Recruiting
65
Novartis Investigative Site
Caserta, CE, Italy, 81100
Actively Recruiting
66
Novartis Investigative Site
Grosseto, GR, Italy, 58100
Actively Recruiting
67
Novartis Investigative Site
Milan, MI, Italy, 20138
Actively Recruiting
68
Novartis Investigative Site
Rozzano, MI, Italy, 20089
Actively Recruiting
69
Novartis Investigative Site
Perugia, PG, Italy, 06129
Actively Recruiting
70
Novartis Investigative Site
Pordenone, PN, Italy, 33170
Actively Recruiting
71
Novartis Investigative Site
Salerno, SA, Italy, 84131
Actively Recruiting
72
Novartis Investigative Site
Legnago, VR, Italy, 37045
Actively Recruiting
73
Novartis Investigative Site
The Hague, South Holland, Netherlands, 2545 AA
Actively Recruiting
74
Novartis Investigative Site
Enschede, Netherlands, 7512KZ
Actively Recruiting
75
Latin Clinical Trial Center Inc
San Juan, Puerto Rico, 00909
Actively Recruiting
76
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
77
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
78
Novartis Investigative Site
Castilleja de la Cuesta, Sevilla, Spain, 41950
Actively Recruiting
79
Novartis Investigative Site
A Coruña, Spain, 15006
Actively Recruiting
80
Novartis Investigative Site
Barcelona, Spain, 08023
Actively Recruiting
81
Novartis Investigative Site
Córdoba, Spain, 14004
Actively Recruiting
82
Novartis Investigative Site
Huelva, Spain, 21080
Actively Recruiting
83
Novartis Investigative Site
Las Palmas GC, Spain, 35010
Actively Recruiting
84
Novartis Investigative Site
Salamanca, Spain, 37007
Actively Recruiting
85
Novartis Investigative Site
Valencia, Spain, 46010
Actively Recruiting
86
Novartis Investigative Site
Valencia, Spain, 46014
Actively Recruiting
87
Novartis Investigative Site
Changhua, Taiwan, 50006
Actively Recruiting
88
Novartis Investigative Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
89
Novartis Investigative Site
Tainan, Taiwan, 704
Actively Recruiting
90
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
91
Novartis Investigative Site
Taipei, Taiwan, 11217
Actively Recruiting
92
Novartis Investigative Site
Chichester, West Sussex, United Kingdom, PO19 6SE
Actively Recruiting
93
Novartis Investigative Site
London, United Kingdom, EC1M 6BQ
Actively Recruiting
94
Novartis Investigative Site
London, United Kingdom, W12 0HS
Actively Recruiting
95
Novartis Investigative Site
Manchester, United Kingdom, M13 9WL
Actively Recruiting
96
Novartis Investigative Site
Tyne and Wear, United Kingdom, NE29 8NH
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here