Trials / Recruiting
RecruitingNCT06813911
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-04-30
- Primary completion
- 2028-02-03
- Completion
- 2028-02-29
- First posted
- 2025-02-07
- Last updated
- 2026-04-16
Locations
92 sites across 11 countries: United States, China, France, Germany, Hong Kong, Italy, Netherlands, Puerto Rico, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06813911. Inclusion in this directory is not an endorsement.