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Pelacarsen s.c

Phase 3

Hyperlipoproteinemia(a) | Small molecule | Metabolic |Novartis AG|Last Updated: Jul 17, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

Pelacarsen s.c · 1 trial · 1 indication

Phase 3 1
NCT05305664A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in GermanyHyperlipoproteinemia(a)
COMPLETED51 Analytics
PHASE3COMPLETED
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany
Hyperlipoproteinemia(a)
NCT0530566451
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Study Endpoints

Primary Endpoints

Rate of Lipoprotein Apheresis Sessions Performed Over 52 Weeks Normalized to the Weekly Lipoprotein Apheresis Schedule
Up to Week 52

Rate (proportion) of apheresis sessions was calculated as the number of actual lipoprotein apheresis (LA) sessions received, divided by the number of planned LA sessions during the 52-week period, which is 52 for patients who completed all study visits, or pro-rated for those who discontinued early. This rate could range from 0 to 1, with 0 indicating that the patient had skipped all planned LA sessions, and 1 indicating that the patient had received all planned sessions. Multiple imputation for missing Lp(a) data was performed, and missing apheresis data was imputed.

Secondary Endpoints

Time to Lipoprotein Apheresis Avoidance
From randomization up to Week 52
Number of Participants With Total Lipoprotein Apheresis Avoidance From Week 12 to Week 52
Week 12 up to Week 52
Change From Baseline to Week 52 in the Log-transformed Lp(a) Reported as mg/dL
Baseline, week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pelacarsen (TQJ230)EXPERIMENTALPelacarsen (TQJ230) 80 mg s.c. Q4W
PlaceboPLACEBO_COMPARATORPlacebo to Pelacarsen s.c. Q4W

Interventions

NameTypeDescription
Pelacarsen (TQJ230) 80 mg s.c.DRUGPelacarsen (TQJ230) 80 mg s.c. Q4W
Corresponding PlaceboDRUGPlacebo to Pelacarsen
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Patients currently undergoing lipoprotein apheresis for isolated Lp(a) on a weekly schedule in Germany for ≥ 12 months prior to screening with at least 40 sessions within the past 52 weeks prior to randomization * Lipoprotein(a) (Lp(a))\> 60 mg/dL at screening * Spontaneous pr...

Countries:Germany
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Recent Changes (Last 90 Days)

MEDIUMAug 17, 2026NCT05305664TRIAL_REMOVED: changed
MEDIUMAug 17, 2026NCT05305664TRIAL_REMOVED: changed
MEDIUMAug 17, 2026NCT05305664TRIAL_REMOVED: changed

Frequently asked questions about Pelacarsen s.c

What is Pelacarsen s.c used for?

Pelacarsen s.c is an investigational small molecule being developed for hyperlipoproteinemia(a), a condition of elevated lipoprotein(a) levels. It is studied in patients with established cardiovascular disease. The drug is administered subcutaneously and is currently in Phase 3 clinical development.

Who makes Pelacarsen s.c?

Pelacarsen s.c is developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker NVS. The drug is being investigated for the treatment of hyperlipoproteinemia(a) and is currently in Phase 3 clinical trials.

What phase is Pelacarsen s.c in?

Pelacarsen s.c is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its effects on the rate of lipoprotein apheresis sessions in patients with hyperlipoproteinemia(a) and established cardiovascular disease.

What clinical trials is Pelacarsen s.c in?

Pelacarsen s.c has one completed Phase 3 trial, NCT05305664, which enrolled 51 participants in Germany. The trial assessed the impact of lipoprotein(a) lowering with pelacarsen on the rate of weekly lipoprotein apheresis sessions in patients with hyperlipoproteinemia(a) and established cardiovascular disease. It was randomized, double-blind, and placebo-controlled.

Is Pelacarsen s.c the same as TQJ230?

Yes, Pelacarsen s.c is also known as TQJ230. In clinical trials, the drug is referred to by both names. For example, the Phase 3 trial NCT05305664 is titled 'A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions.'