Clinical trial NCT06813911: Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atherosclerotic Cardiovascular Disease (ASCVD)
Keywords: Lipoprotein(a)
cardiovascular disease
ASCVD
pelacarsen (TQJ230)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-02-07
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Key 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

Key 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.

Primary outcomes:
measure: Change in log transformed lipoprotein A (Lp(a)) concentration
timeFrame: Baseline, 6 Months
Secondary outcomes:
measure: Proportion of participants achieving reduction in Lp(a) levels at Month 6
timeFrame: Baseline, Month 6
measure: Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
timeFrame: 16 Months
measure: Incidence of treatment emergent adverse events of special interest (AESI)
timeFrame: 12 Months
measure: Incidence of study and treatment discontinuations due to TEAEs
timeFrame: 12 Months
Other outcomes:
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