RECRUITING

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

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).

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)
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Related Conditions:

Atherosclerotic Cardiovascular Disease (ASCVD)

Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Atherosclerotic Cardiovascular Disease (ASCVD)
Intervention / Treatment

-

Contacts and Locations

Boca Raton

Excel Medical Clinical Trials LLC, Boca Raton, Florida, United States, 33434

Miami Lakes

Inpatient Research Clinical LLC, Miami Lakes, Florida, United States, 33014

Miami Lakes

Inpatient Research Clinical LLC, Miami Lakes, Florida, United States, 33014

Miramar

Eminat LLC, Miramar, Florida, United States, 33027

Metairie

Omega Clinical Research, Metairie, Louisiana, United States, 70006

Fort Washington

Anderson Medical Research, Fort Washington, Maryland, United States, 20744

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Tullahoma

Cardiology Group, Tullahoma, Tennessee, United States, 37388

Tomball

Northwest Houston Clinical Research PLLC, Tomball, Texas, United States, 77375

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Study Record Dates

2027-12-01