RECRUITING

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Atherosclerotic Cardiovascular Disease (ASCVD), and Elevated LDL-C and Lp(a)

Quick Facts

Study Start:2025-04-30
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06813911

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female participants 18 to ≤80 years of age at Screening visit
  2. * Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
  3. * On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
  4. * Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
  5. * 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
  6. * Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
  7. * Central laboratory reported LDL-C \>70 mg/dL (or \>1.8 mmol/L) at Screening visit
  1. * Prior treatment with inclisiran
  2. * Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
  3. * Uncontrolled hypertension at Randomization/Baseline visit
  4. * Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
  5. * Triglycerides ≥400 mg/dL at Screening visit
  6. * History of malignancy of any organ system within the past 5 years
  7. * 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)
  8. * Central laboratory reported platelet count \<140,000 per mm3
  9. * Active liver disease or hepatic dysfunction at Screening visit
  10. * Significant kidney disease at Screening visit
  11. * Pregnant or nursing women at Screening visit
  12. * Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit
  13. * Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Study Locations (Sites)

Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434
United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
United States
Eminat LLC
Miramar, Florida, 33027
United States
Omega Clinical Research
Metairie, Louisiana, 70006
United States
Anderson Medical Research
Fort Washington, Maryland, 20744
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Cardiology Group
Tullahoma, Tennessee, 37388
United States
Northwest Houston Clinical Research PLLC
Tomball, Texas, 77375
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2025-04-30
Study Completion Date2027-12-01

Terms related to this study

Keywords Provided by Researchers

  • Lipoprotein(a)
  • cardiovascular disease
  • ASCVD
  • pelacarsen (TQJ230)

Additional Relevant MeSH Terms

  • Atherosclerotic Cardiovascular Disease (ASCVD)