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

NCT05305664 | Completed Phase 3

• 2 other identifiers: CTQJ230A123022021-003059-41
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 13

Brief Summary

Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly schedule.

Conditions

Hyperlipoproteinemia(a)

Keywords

Lipoprotein (a); cardiovascular disease; apheresis; TQJ230; pelacarsen

Outcome Measures

Primary Outcomes (1)

• Rate of lipoprotein apheresis sessions performed over 52 weeks normalized to the weekly lipoprotein apheresis schedule

  Demonstrate superiority of pelacarsen (TQJ230) compared to placebo in reducing the rate of lipoprotein apheresis sessions in patients with hyperlipoproteinemia(a) and established CVD during 52 weeks of treatment

  Over 52 Weeks

Secondary Outcomes (3)

• Time to lipoprotein apheresis avoidance (where lipoprotein apheresis avoidance is defined as at least 24 weeks of no lipoprotein apheresis until end of study)

  At least 24 weeks up to Week 52

• Total avoidance of lipoprotein apheresis from week 12 to week 52

  Week 12 to Week 52

• Change from baseline to week 52 in the log-transformed Lp(a) (measured prior to planned lipoprotein apheresis)

  52 weeks

Other Outcomes (5)

• Rate of lipoprotein apheresis sessions from week 12 to week 52 and week 24 to week 52 normalized to the weekly lipoprotein apheresis schedule

  Week 12 to 52, Week 24 to 52

• Total avoidance of lipoprotein apheresis between week 24 to week 52

  Week 24 to Week 52

• Time-averaged Lp(a) levels

  52 weeks

Study Arms (2)

Pelacarsen (TQJ230)

EXPERIMENTAL

Drug: Pelacarsen (TQJ230) 80 mg s.c.

Placebo

PLACEBO COMPARATOR

Drug: Corresponding Placebo

Interventions

Pelacarsen (TQJ230) 80 mg s.c. DRUG

Pelacarsen (TQJ230) 80 mg s.c. Q4W

Also known as: TQJ230

Pelacarsen (TQJ230)

Corresponding Placebo DRUG

Placebo to Pelacarsen

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 prior myocardial infarction (MI): ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
• Ischemic stroke: ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
• Clinically significant symptomatic peripheral artery disease (PAD)

You may not qualify if:

• Uncontrolled hypertension
• Heart failure New York Heart Association (NYHA) class IV
• History of malignancy of any organ system
• History of hemorrhagic stroke or other major bleeding
• Platelet count \<140,000 per mm3 at screening
• Active liver disease or hepatic dysfunction
• Significant kidney disease
• Pregnant or nursing women

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, 42010, Germany

Location

Novartis Investigative Site

Geilenkirchen, North Rhine-Westphalia, 52511, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Cloppenburg, 49661, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Frankfurt, 60431, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Villingen-Schwenningen, D78052, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

pelacarsen

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 31, 2022
• Study Start: August 19, 2022
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (13)