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Heart drug pelacarsen moves to Long-Term safety check in 600 patients

NCT ID NCT06875973

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study is for people with high levels of Lp(a), a genetic risk factor for heart disease, who have already completed a prior pelacarsen trial. It will give them continued access to the drug while monitoring long-term safety and how well it keeps Lp(a) levels low. About 600 participants will receive monthly injections of pelacarsen for up to several years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pelacarsen (a monthly injection to lower Lp(a))
What this could lead to
If successful, this could confirm pelacarsen as a safe long-term treatment to lower Lp(a) and potentially reduce heart disease risk.
What could go wrong
This is an open-label extension, not a placebo-controlled trial, so results are less definitive. Long-term safety and effectiveness are still being evaluated.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 599 people

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

Started

May 2025

Expected to finish

Dec 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

18 to 100 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: * Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. * Participants who have completed the parent study and received the assigned study treatment at the time of its completion Exclusion Criteria: * Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study * Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation * Participants who are receiving another investigational drug or device before the open-label treatment period * Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease

As listed by the trial registrant

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

Atherosclerotic cardiovascular disease

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    81 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • A&A Research Group Inc

    RECRUITING

    Miami, Florida, 33186, United States

  • AB Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Aa Mrc Llc

    ACTIVE_NOT_RECRUITING

    Flint, Michigan, 48504, United States

  • Aa Mrc Mhs

    RECRUITING

    Flint, Michigan, 48503, United States

  • Advanced Clinical Research LLC

    RECRUITING

    Bayamón, 00959, Puerto Rico

  • Alliance Medical Ministry

    RECRUITING

    Raleigh, North Carolina, 27610, United States

  • Anderson Medical Research

    ACTIVE_NOT_RECRUITING

    Ft. Washington, Maryland, 20744, United States

  • Angel City Research Inc

    RECRUITING

    Los Angeles, California, 90026, United States

  • Angiocardiac Care of Texas PA

    RECRUITING

    Houston, Texas, 77025, United States

  • Apex Cardiology Research Associates of Jackson

    RECRUITING

    Jackson, Tennessee, 38301, United States

  • Ascension Saint Agnes Heart Care

    RECRUITING

    Baltimore, Maryland, 21229, United States

  • Atlanta Heart Specialists LLC

    RECRUITING

    Tucker, Georgia, 30084, United States

  • Baptist Health South

    RECRUITING

    Miami, Florida, 33173, United States

  • C and A Clinical Trials

    RECRUITING

    Cape Coral, Florida, 33990, United States

  • CAIMED Center

    RECRUITING

    Ponce, 00716, Puerto Rico

  • CTMD Research

    RECRUITING

    Palm Springs, Florida, 33406, United States

  • CV Ins of the South

    RECRUITING

    Opelousas, Louisiana, 70570, United States

  • California Medical Research Associates Inc

    ACTIVE_NOT_RECRUITING

    Northridge, California, 91324, United States

  • Capitol Cardiology Associates

    RECRUITING

    Lanham, Maryland, 20706, United States

  • Cardiology Partners Clinical Research Institute

    RECRUITING

    Wellington, Florida, 33449, United States

  • Cardiology and Medicine Clinic PA

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Cardiovascular Associates Research

    RECRUITING

    Covington, Louisiana, 70433, United States

    Contact Email: •••••@•••••

  • Care Access Research

    RECRUITING

    Easton, Pennsylvania, 18045, United States

  • Chicago Clinical Research Inst

    RECRUITING

    Chicago, Illinois, 60607, United States

  • Clinical Research of South Nevada

    RECRUITING

    Las Vegas, Nevada, 89121, United States

  • Clinical Trials of Texas

    ACTIVE_NOT_RECRUITING

    San Antonio, Texas, 78229, United States

  • Columbus Clinical Services LLC

    RECRUITING

    Miami, Florida, 33125, United States

  • DBC Research USA

    RECRUITING

    Pembroke Pines, Florida, 33029, United States

  • Dallas Heart and Vascular Consultants PA

    RECRUITING

    Houston, Texas, 77084, United States

  • Dallas Heart and Vascular Consultants PA

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77084, United States

  • Dallas Heart and Vascular Consultants PA

    RECRUITING

    Houston, Texas, 77084, United States

  • David Turbay MD PLLC

    RECRUITING

    El Paso, Texas, 79905, United States

  • Discovery Clinical Trials

    RECRUITING

    Pflugerville, Texas, 78660-3015, United States

  • Dominion Medical Associates

    ACTIVE_NOT_RECRUITING

    Richmond, Virginia, 23219, United States

  • Dr Yolanda Figueroa Private Pr

    RECRUITING

    Humacao, 00791, Puerto Rico

  • Elite Clinical Research

    RECRUITING

    Jackson, Mississippi, 39202, United States

  • Epic Clinical Research

    RECRUITING

    Lewisville, Texas, 75057, United States

  • Excel Medical Clinical Trials LLC

    ACTIVE_NOT_RECRUITING

    Boca Raton, Florida, 33434, United States

  • FXM Clin Res Miramar LLC

    ACTIVE_NOT_RECRUITING

    Miramar, Florida, 33027, United States

  • Finlay Medical Research

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33126, United States

  • Flourish Research

    ACTIVE_NOT_RECRUITING

    Winter Park, Florida, 32789, United States

  • Flourish Research

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Heart Care Associates P C

    RECRUITING

    Hopewell, Virginia, 23860, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hope Clinical Research

    RECRUITING

    Canoga Park, California, 91303, United States

  • Infinite Clinical Research

    RECRUITING

    Miami, Florida, 33133, United States

  • Inpatient Research Clinical LLC

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Inpatient Research Clinical LLC

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • International Research Associates LLC

    RECRUITING

    Miami, Florida, 33156, United States

  • Jamaica Hospital Medical Center

    RECRUITING

    Richmond Hill, New York, 11418, United States

  • James A Haley Veterans Hospital

    RECRUITING

    Tampa, Florida, 33612, United States

  • Javara Research

    RECRUITING

    Alexandria, Virginia, 22311, United States

  • Javara Research

    RECRUITING

    Alexandria, Virginia, 22311, United States

  • Javara Research

    RECRUITING

    Alexandria, Virginia, 22311, United States

  • Javara Research

    RECRUITING

    Alexandria, Virginia, 22311, United States

  • Johns Hopkins Univ School of Med

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Johns Hopkins University

    RECRUITING

    Columbia, Maryland, 21044, United States

  • Las Vegas Endocrinology

    RECRUITING

    Henderson, Nevada, 89074, United States

  • Latin Clinical Trial Center Inc

    RECRUITING

    San Juan, 00909, Puerto Rico

  • Long Beach Clinical Trials

    RECRUITING

    Long Beach, California, 90806, United States

  • MD Medical Research

    RECRUITING

    Oxon Hill, Maryland, 20745, United States

  • Metropolitan Cardiovascular Consultants Llc

    RECRUITING

    Beltsville, Maryland, 20705, United States

  • Monroe Biomedical Research

    RECRUITING

    Monroe, North Carolina, 28112, United States

  • Monroe Research Llc

    RECRUITING

    West Monroe, Louisiana, 71291, United States

  • Morehouse School Of Medicine

    RECRUITING

    Atlanta, Georgia, 30310, United States

  • NICRs Research Center

    ACTIVE_NOT_RECRUITING

    Garden Grove, California, 92844, United States

  • National Heart Institute

    RECRUITING

    Beverly Hills, California, 90211, United States

  • National Research Institute

    RECRUITING

    Hialeah, Florida, 33013, United States

  • New Tampa Health

    RECRUITING

    Tampa, Florida, 33603, United States

  • NexGen Research

    RECRUITING

    Lima, Ohio, 45801, United States

  • North Hills Medical Research Inc

    ACTIVE_NOT_RECRUITING

    Bedford, Texas, 76021, United States

  • Omega Clinical Research

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Overlook Medical Center

    RECRUITING

    Summit, New Jersey, 07901, United States

  • Parkway Medical Center

    RECRUITING

    Birmingham, Alabama, 35215, United States

  • Pharma Tex Research

    RECRUITING

    Amarillo, Texas, 79106, United States

  • Plano Primary Care Clinic

    RECRUITING

    Allen, Texas, 75002-3688, United States

  • Proactive Clinical Research

    RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Proactive Clinical Research

    ACTIVE_NOT_RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Research and Cardiovascular Corp

    RECRUITING

    Ponce, 00717-1322, Puerto Rico

  • Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • SW Family Medicine Associates

    RECRUITING

    Dallas, Texas, 75235, United States

  • Sinai Ct for Throm Res and Drug Dev

    RECRUITING

    Baltimore, Maryland, 21209, United States

  • Sister Life Research Inc

    RECRUITING

    Hialeah, Florida, 33013, United States

  • Southern Clin Research Clinic

    ACTIVE_NOT_RECRUITING

    Zachary, Louisiana, 70791, United States

  • Stanford Health Care

    RECRUITING

    Stanford, California, 94305, United States

  • Stern Cardiovascular Foundation Inc

    RECRUITING

    Southaven, Mississippi, 38671, United States

  • Synexus Clinical Research US Inc

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60602, United States

  • TCV Clinical Studies

    RECRUITING

    Linwood, Pennsylvania, 19061, United States

  • The Heart Institute of East Texas

    RECRUITING

    Lufkin, Texas, 75904, United States

  • University of Calif Irvine Med Cntr

    RECRUITING

    Irvine, California, 92660, United States

  • University of Texas Health Science Ctr

    RECRUITING

    San Antonio, Texas, 78229-3900, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • VA Caribbean Healthcare System

    RECRUITING

    San Juan, 00921, Puerto Rico

  • Valley Clinical Trials Inc

    ACTIVE_NOT_RECRUITING

    Covina, California, 91723, United States

  • Vcu Health

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Virginia Heart

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Zenith Clinical Research

    RECRUITING

    Hollywood, Florida, 33021, United States

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