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Recruiting NCT06813911

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

Phase III Interventional Atherosclerotic Cardiovascular Disease (ASCVD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pelacarsen, Placebo, Inclisiran.
Who it may be relevant to
Registry conditions: Atherosclerotic Cardiovascular Disease (ASCVD). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China, France, Germany, Hong Kong +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

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).

Detailed description

This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.

Interventions

  • Drug Pelacarsen
    Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
  • Drug Placebo
    Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.
  • Drug Inclisiran
    All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11.

Primary outcome measures

  • Change in log transformed lipoprotein A (Lp(a)) concentration [Time frame: Baseline, 6 Months]
Secondary outcome measures (4)
  • Proportion of participants achieving reduction in Lp(a) levels at Month 6 [Time frame: Baseline, Month 6]
  • Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) [Time frame: 16 Months]
  • Incidence of treatment emergent adverse events of special interest (AESI) [Time frame: 12 Months]
  • Incidence of study and treatment discontinuations due to TEAEs [Time frame: 12 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 36 centers
  • Parkway Medical Center — Birmingham
  • Clinical Research Inst of Arizona — Sun City West
  • National Heart Institute — Beverly Hills
  • Interv Cardiology Med Grp — West Hills
  • Excel Medical Clinical Trials LLC — Boca Raton
  • Jacksonville Center for Clinical — Jacksonville
  • K2 Medical Research LLC — Maitland
  • University of Miami Hospital — Miami
  • … and 28 more centers
Spain · 11 centers
  • Novartis Investigative Site — Santiago Compostela
  • Novartis Investigative Site — Pamplona
  • Novartis Investigative Site — Castilleja de la Cuesta
  • Novartis Investigative Site — A Coruña
  • Novartis Investigative Site — Barcelona
  • Novartis Investigative Site — Córdoba
  • … and 5 more centers
Germany · 10 centers
  • Novartis Investigative Site — Stuttgart
  • Novartis Investigative Site — Potsdam
  • Novartis Investigative Site — Chemnitz
  • Novartis Investigative Site — Leipzig
  • Novartis Investigative Site — Berlin
  • Novartis Investigative Site — Bielefeld
  • Novartis Investigative Site — Gelnhausen
  • Novartis Investigative Site — Mannheim
  • … and 2 more centers
France · 9 centers
  • Novartis Investigative Site — Béziers
  • Novartis Investigative Site — Cholet
  • Novartis Investigative Site — Grenoble
  • Novartis Investigative Site — Lille
  • Novartis Investigative Site — Montpellier
  • Novartis Investigative Site — Paris
  • Novartis Investigative Site — Pessac
  • Novartis Investigative Site — Poitiers
  • … and 1 more center
Italy · 9 centers
  • Novartis Investigative Site — Ancona
  • Novartis Investigative Site — Caserta
  • Novartis Investigative Site — Grosseto
  • Novartis Investigative Site — Milan
  • Novartis Investigative Site — Rozzano
  • Novartis Investigative Site — Perugia
  • Novartis Investigative Site — Pordenone
  • Novartis Investigative Site — Salerno
  • … and 1 more center
China · 5 centers
  • Novartis Investigative Site — Yinchuan
  • Novartis Investigative Site — Jining
  • Novartis Investigative Site — Xian
  • Novartis Investigative Site — Beijing
  • Novartis Investigative Site — Shanghai
Taiwan · 5 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 5 centers

Center list to be confirmed — check the primary protocol.

Hong Kong · 2 centers
  • Novartis Investigative Site — Hong Kong
  • Novartis Investigative Site — Hong Kong
Netherlands · 2 centers
  • Novartis Investigative Site — The Hague
  • Novartis Investigative Site — Enschede
Puerto Rico · 1 center
  • Latin Clinical Trial Center Inc — San Juan

Identifiers

NCT: NCT06813911 · CTQJ230A12304

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗