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Pelacarsen for Aortic Stenosis

Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mild or moderate calcific aortic valve stenosis
Be older than 18 years old
Must not have
History of hemorrhagic stroke or other major bleeding
Significant kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months

Summary

"This trial aims to see if pelacarsen given as a monthly injection can slow down the progression of calcific aortic valve stenosis compared to a placebo."

Who is the study for?
This trial is for men and women aged 50 or older with a blood level of Lipoprotein(a) at or above 125 nmol/L, as measured by the central lab. Participants should have mild to moderate calcific aortic valve stenosis but no other details are provided about who might be excluded.
What is being tested?
The study tests Pelacarsen (TQJ230), given as a monthly subcutaneous injection, against a placebo to see if it can slow down the worsening of calcific aortic valve stenosis—a heart condition where the valve narrows and hardens.
What are the potential side effects?
While specific side effects aren't listed here, generally such injections could cause reactions at the injection site, potential liver issues due to lipid changes, allergic responses, and possibly influence bleeding risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart valve condition is not severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a major bleeding event or a stroke caused by bleeding.
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I have a serious kidney condition.
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I have severe narrowing of my heart's aortic valve due to calcium buildup.
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My high blood pressure is not under control.
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I have liver disease or a liver condition.
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I have had cancer in any part of my body before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in aortic valve calcium score
Change in peak aortic jet velocity
Secondary study objectives
Change in Lp(a) levels
Change in fibrocalcific thickening of the aortic valve
Time from randomization to first occurrence of composite clinical endpoint event

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pelacarsen (TQJ230) 80mgExperimental Treatment1 Intervention
Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
Group II: Matching placeboPlacebo Group1 Intervention
Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,201 Total Patients Enrolled
~335 spots leftby Jan 2029
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