NCT05900141

Brief Summary

This non-randomized, open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the double-blind parent study (CTQJ230A12302).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
28mo left

Started Sep 2023

Longer than P75 for phase_3

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Sep 2023Aug 2028

First Submitted

Initial submission to the registry

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2028

Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

4.9 years

First QC Date

June 2, 2023

Last Update Submit

August 1, 2025

Conditions

Hyperlipoproteinemia (a)

Keywords

Lipoprotein(a)Cardiovascular diseaseApheresisPost trial accesspelacarsen (TQJ230)

Outcome Measures

Primary Outcomes (2)

  • Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.

    Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established cardiovascular disease who have competed the parent study

    60 months

  • Duration of drug exposure

    Duration of drug exposure will be collected

    60 months

Secondary Outcomes (3)

  • Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5

    60 months

  • Absolute change in Lp(a) compared to baseline of the parent study.

    month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)

  • Percentage change in Lp(a) compared to baseline of the parent study.

    month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)

Study Arms (1)

Pelacarsen (TQJ230)

EXPERIMENTAL

open-label pelacarsen 80 mg

Drug: Pelacarsen

Interventions

PelacarsenDRUG

Pelacarsen 80mg s.c. monthly

Also known as: TQJ230
Pelacarsen (TQJ230)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement.

You may not qualify if:

  • Any medical condition(s) that may put the participant at risk in the investigator's opinion
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, unless they are using effective methods of contraception during dosing and for 16 weeks (= 5 times the terminal half-life) after stopping of study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative Site

Frankfurt am Main, Hesse, 60431, 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

Mainz, 55131, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

HyperlipoproteinemiasCardiovascular Diseases

Interventions

pelacarsen

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Masking Details
Open label study
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label extension (OLE) study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

September 29, 2023

Primary Completion (Estimated)

August 24, 2028

Study Completion (Estimated)

August 24, 2028

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Locations

DE(9)