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

Phase 3

Not yet recruiting

• Conditions: Atherosclerotic Cardiovascular Disease (ASCVD)
• Interventions: Drug: Pelacarsen; Drug: Inclisiran; Drug: Placebo

• Registration Number: NCT06813911
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-18
• Study Start: 2025-05-28
• Primary Completion: 2027-08-27
• Study Completion: 2027-12-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelacarsen	Pelacarsen	Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months.
Pelacarsen	Inclisiran	Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months.
Placebo	Pelacarsen	Participants will be administered placebo subcutaneous injection once monthly for 6 months. After Month 6, all participants will receive pelacarsen 80 mg injection for the remaining 6 months during the open-label treatment period.
Placebo	Placebo	Participants will be administered placebo subcutaneous injection once monthly for 6 months. After Month 6, all participants will receive pelacarsen 80 mg injection for the remaining 6 months during the open-label treatment period.
Placebo	Inclisiran	Participants will be administered placebo subcutaneous injection once monthly for 6 months. After Month 6, all participants will receive pelacarsen 80 mg injection for the remaining 6 months during the open-label treatment period.

Primary Outcome Measures

Name	Time	Method
Change in log transformed lipoprotein A (Lp(a)) concentration	Baseline, 6 Months	To evaluate the efficacy of Pelacarsen compared to placebo, in reducing Lp(a) levels at Month 6 in ASCVD participants who have elevated Lp(a), and who are on background inclisiran for elevated LDL-C

Secondary Outcome Measures

Name	Time	Method
Proportion of participants achieving reduction in Lp(a) levels at Month 6	Baseline, Month 6	Efficacy of pelacarsen versus placebo in reducing Lp(a)
Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)	16 Months	The TEAEs will be defined as any recorded AE with start date located in the on-treatment period. To understand the effect of pelacarsen versus placebo on safety and tolerability in participants treated with background inclisiran. Incidence and severity of AEs by treatment group, including changes in the vital signs, electrocardiogram and laboratory results qualifying and reported as AEs.
Incidence of treatment emergent adverse events of special interest (AESI)	12 Months	To understand the effect of pelacarsen versus placebo on safety and tolerability in participants treated with background inclisiran
Incidence of study and treatment discontinuations due to TEAEs	12 Months	Incidence proportion of study discontinuations due to TEAEs