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Can a monthly shot slow stiff heart valves? new trial aims to find out.

NCT ID NCT05646381

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a monthly injection called pelacarsen to see if it can slow the worsening of calcific aortic valve stenosis, a condition where the heart valve becomes stiff and narrow. About 502 adults aged 50-79 with high levels of lipoprotein(a) and mild-to-moderate valve disease will receive either the drug or a placebo for 3 years. The main goal is to measure changes in blood flow through the valve and calcium buildup using heart scans.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 502 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female ≥50 to \<80 years of age at Screening Part II * Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory * Mild or moderate calcific aortic valve stenosis * At the randomization visit, participant must be optimally treated for existing CV risk factors Exclusion Criteria: * Severe calcific aortic valve stenosis * Uncontrolled hypertension * History of malignancy of any organ system * History of hemorrhagic stroke or other major bleeding * Platelet count ≤ LLN * Active liver disease or hepatic dysfunction * Significant kidney disease * Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    130 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AA Medical Research Center

    RECRUITING

    Flint, Michigan, 48504, United States

  • Advanced Research for Health Improvement LLC

    WITHDRAWN

    Naples, Florida, 34102, United States

  • Brigham and Womens Hosp Harvard Med School

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Brigham and Womens Hosp Harvard Med School

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Capital Cardiology Associates

    RECRUITING

    Albany, New York, 12211, United States

  • Cardiovascular Res Found

    RECRUITING

    Beverly Hills, California, 90210, United States

  • Carient Heart and Vascular

    RECRUITING

    Manassas, Virginia, 20109, United States

  • Excel Medical Clinical Trials LLC

    WITHDRAWN

    Boca Raton, Florida, 33434, United States

  • Flourish Clinical Resrch Covin

    RECRUITING

    Covina, California, 91723, United States

  • Flourish Res Acq LLC North Miami

    RECRUITING

    Miami, Florida, 33138, United States

  • Heart Center Research Llc

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Icahn School of Med at Mt Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Inpatient Research Clinical LLC

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Lindner Ctr At The Christ Hosp

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Midwest Heart and Vascular Spec

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • Minneapolis Heart Institute

    WITHDRAWN

    Minneapolis, Minnesota, 55407, United States

  • National Heart Institute

    RECRUITING

    Beverly Hills, California, 90211, United States

  • New York Presbyterian Hospital

    ACTIVE_NOT_RECRUITING

    New York, New York, 10021, United States

  • Nova Clinical Research LLC

    RECRUITING

    Bradenton, Florida, 34209, United States

  • Novartis Investigative Site

    RECRUITING

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    WITHDRAWN

    Linz, 4021, Austria

  • Novartis Investigative Site

    RECRUITING

    Vienna, 1100, Austria

  • Novartis Investigative Site

    RECRUITING

    Vienna, 1190, Austria

  • Novartis Investigative Site

    RECRUITING

    Vienna, A 1090, Austria

  • Novartis Investigative Site

    RECRUITING

    Genk, Limburg, 3600, Belgium

  • Novartis Investigative Site

    RECRUITING

    Yvoir, Namur, 5530, Belgium

  • Novartis Investigative Site

    RECRUITING

    Aalst, Oost Vlaanderen, 9300, Belgium

  • Novartis Investigative Site

    RECRUITING

    Kortrijk, West-Vlaanderen, 8500, Belgium

  • Novartis Investigative Site

    RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Novartis Investigative Site

    RECRUITING

    Cambridge, Ontario, N1R 6V6, Canada

  • Novartis Investigative Site

    RECRUITING

    North York, Ontario, M6B 3H7, Canada

  • Novartis Investigative Site

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Novartis Investigative Site

    RECRUITING

    Hradec Králové, 500 02, Czechia

  • Novartis Investigative Site

    RECRUITING

    Jaroměř, 551 01, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 14021, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    RECRUITING

    Esbjerg, 6700, Denmark

  • Novartis Investigative Site

    RECRUITING

    Hvidovre, 2650, Denmark

  • Novartis Investigative Site

    RECRUITING

    Roskilde, 4000, Denmark

  • Novartis Investigative Site

    RECRUITING

    Viborg, 8800, Denmark

  • Novartis Investigative Site

    RECRUITING

    Paris, 75012, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75013, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75015, France

  • Novartis Investigative Site

    RECRUITING

    Pessac, 33604, France

  • Novartis Investigative Site

    RECRUITING

    Poitiers, 86021, France

  • Novartis Investigative Site

    RECRUITING

    Rennes, 35033, France

  • Novartis Investigative Site

    RECRUITING

    Frankfurt am Main, Hesse, 60594, Germany

  • Novartis Investigative Site

    RECRUITING

    Kaiserslautern, Rhineland-Palatinate, 67655, Germany

  • Novartis Investigative Site

    RECRUITING

    Dresden, Saxony, 01099, Germany

  • Novartis Investigative Site

    RECRUITING

    Leipzig, Saxony, 04289, Germany

  • Novartis Investigative Site

    RECRUITING

    Ahaus, 48683, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 13353, Germany

  • Novartis Investigative Site

    RECRUITING

    Bonn, 53105, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    RECRUITING

    Hamburg, 22763, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Lüneburg, 21339, Germany

  • Novartis Investigative Site

    RECRUITING

    Mannheim, 68165, Germany

  • Novartis Investigative Site

    RECRUITING

    München, 80636, Germany

  • Novartis Investigative Site

    RECRUITING

    Münster, 48149, Germany

  • Novartis Investigative Site

    RECRUITING

    Oldenburg, 26133, Germany

  • Novartis Investigative Site

    RECRUITING

    Beersheba, 8457108, Israel

  • Novartis Investigative Site

    RECRUITING

    Haifa, 3104802, Israel

  • Novartis Investigative Site

    RECRUITING

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    RECRUITING

    Jerusalem, 9103102, Israel

  • Novartis Investigative Site

    RECRUITING

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    RECRUITING

    Nahariya, 2210001, Israel

  • Novartis Investigative Site

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    RECRUITING

    Ancona, AN, 60126, Italy

  • Novartis Investigative Site

    RECRUITING

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    WITHDRAWN

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    RECRUITING

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    RECRUITING

    Caserta, CE, 81100, Italy

  • Novartis Investigative Site

    RECRUITING

    Cona, FE, 44124, Italy

  • Novartis Investigative Site

    RECRUITING

    Pozzilli, IS, 86077, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20138, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20157, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    RECRUITING

    Padova, PD, 35128, Italy

  • Novartis Investigative Site

    RECRUITING

    Pordenone, PN, 33170, Italy

  • Novartis Investigative Site

    RECRUITING

    Amsterdam, North Holland, 1090 HM, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Rotterdam, South Holland, 3079 DZ, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Nieuwegein, Utrecht, 3435 CM, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Alcabideche, 2755-009, Portugal

  • Novartis Investigative Site

    RECRUITING

    Braga, 4710243, Portugal

  • Novartis Investigative Site

    RECRUITING

    Coimbra, 3004-561, Portugal

  • Novartis Investigative Site

    RECRUITING

    Vila Nova de Gaia, 4434 502, Portugal

  • Novartis Investigative Site

    RECRUITING

    Cáceres, Extremadura, 10003, Spain

  • Novartis Investigative Site

    RECRUITING

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28034, Spain

  • Novartis Investigative Site

    WITHDRAWN

    Madrid, 28040, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28046, Spain

  • Novartis Investigative Site

    RECRUITING

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46010, Spain

  • Novartis Investigative Site

    RECRUITING

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Geneva, 1211, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Lugano, 6900, Switzerland

  • Novartis Investigative Site

    WITHDRAWN

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Reading, Berkshire, RG1 5AN, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Portadown, Nothern Ireland, BT63 5QQ, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Edinburgh, EH16 4SA, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Leicester, LE3 9QP, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Liverpool, L14 3PE, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Londonderry, BT47 6SB, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Manchester, M23 9LT, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Middlesbrough, TS4 3BW, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Norwich, NR4 7UY, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Tyne and Wear, NE29 8NH, United Kingdom

  • Ohio State University

    WITHDRAWN

    Columbus, Ohio, 43210, United States

  • Orion Medical

    RECRUITING

    Houston, Texas, 77034, United States

  • Overlook Medical Center

    RECRUITING

    Summit, New Jersey, 07901, United States

  • Perelman School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Stanford University Medical Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • Strong Memorial Hospital

    RECRUITING

    Rochester, New York, 14642, United States

  • Texas Heart Institute

    RECRUITING

    Houston, Texas, 77030, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UC San Francisco Medical Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University Of California San Diego

    RECRUITING

    San Diego, California, 92103-8415, United States

  • University Of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Valley Clinical Trials

    RECRUITING

    Northridge, California, 91325, United States

  • Virginia Heart

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Wake Forest University Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • William Beaumont Hospital

    RECRUITING

    Royal Oak, Michigan, 48073-4192, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.