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New drug duo aims to slash heart disease risk by targeting hidden cholesterol

NCT ID NCT06813911

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 3 times

Summary

This study tests whether adding pelacarsen to inclisiran can further lower a type of cholesterol called Lp(a) in people with heart disease. About 340 adults with high Lp(a) and LDL-C will receive either pelacarsen or a placebo, plus inclisiran. The main goal is to see if Lp(a) levels drop after 6 months.

What this could mean

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

Active substance
pelacarsen (TQJ230) and inclisiran
What this could lead to
If successful, this could provide a new treatment option for people with heart disease who still have high cholesterol despite current therapies.
What could go wrong
This is a Phase 3 trial, but it is still experimental. The drug may not lower Lp(a) enough or could cause side effects. Results may not apply to everyone.

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 340 people

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

Started

Apr 2025

Expected to finish

Feb 2028

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 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.

Key Inclusion criteria: * Male and female participants 18 to ≤80 years of age at Screening visit * Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit * On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit * Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized * On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit * Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit * Central laboratory reported LDL-C \>70 mg/dL (or \>1.8 mmol/L) at Screening visit Key Exclusion Criteria: * Prior treatment with inclisiran * Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit * Uncontrolled hypertension at Randomization/Baseline visit * Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1) * Triglycerides ≥400 mg/dL at Screening visit * History of malignancy of any organ system within the past 5 years * Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1) * Central laboratory reported platelet count \<140,000 per mm3 * Active liver disease or hepatic dysfunction at Screening visit * Significant kidney disease at Screening visit * Pregnant or nursing women at Screening visit * Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit * Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease cardiovascular disorder

As listed by the trial registrant

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

Atherosclerotic cardiovascular disease (ascvd)

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

    75 sites in 10 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

  • AB Clinical Trials

    ACTIVE_NOT_RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Aa Mrc Llc

    ACTIVE_NOT_RECRUITING

    Flint, Michigan, 48504, United States

  • Advocate Lutheran General Childrens Hospital

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • American Health Network Research Dept

    RECRUITING

    Muncie, Indiana, 47304, United States

  • American Health Network Research Dept

    RECRUITING

    Muncie, Indiana, 47304, United States

  • Anderson Medical Research

    RECRUITING

    Ft. Washington, Maryland, 20744, United States

    Contact Email: •••••@•••••

  • Baptist Health South

    RECRUITING

    Miami, Florida, 33173, United States

  • Cardiovascular Associates Research

    ACTIVE_NOT_RECRUITING

    Covington, Louisiana, 70433, United States

  • Clinical Research Inst of Arizona

    ACTIVE_NOT_RECRUITING

    Sun City West, Arizona, 85375, United States

  • Excel Medical Clinical Trials LLC

    ACTIVE_NOT_RECRUITING

    Boca Raton, Florida, 33434, United States

  • FC Site Partners Miami

    RECRUITING

    Winter Park, Florida, 32789, United States

  • FXM Clin Res Miramar LLC

    ACTIVE_NOT_RECRUITING

    Miramar, Florida, 33027, United States

  • Flourish Research Bowie

    RECRUITING

    Bowie, Maryland, 20715, United States

  • Henry Ford Hospital

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48202, United States

  • Inpatient Research Clinical LLC

    ACTIVE_NOT_RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Interv Cardiology Med Grp

    ACTIVE_NOT_RECRUITING

    West Hills, California, 91307, United States

  • Jacksonville Center for Clinical

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • K2 Medical Research LLC

    ACTIVE_NOT_RECRUITING

    Maitland, Florida, 32751, United States

  • Kelsey Seybold Research Foundation

    RECRUITING

    Houston, Texas, 77030, United States

  • Latin Clinical Trial Center Inc

    ACTIVE_NOT_RECRUITING

    San Juan, 00909, Puerto Rico

  • MyMichigan Medical Center Midland

    ACTIVE_NOT_RECRUITING

    Midland, Michigan, 48670, United States

  • National Heart Institute

    ACTIVE_NOT_RECRUITING

    Beverly Hills, California, 90211, United States

  • Northwest Houston Clinical Research PLLC

    RECRUITING

    Tomball, Texas, 77375, United States

  • Novartis Investigative Site

    RECRUITING

    Tullahoma, Tennessee, 37388, United States

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Yinchuan, Ningxia, 750004, China

  • Novartis Investigative Site

    RECRUITING

    Jining, Shandong, 272000, China

  • Novartis Investigative Site

    RECRUITING

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200025, China

  • Novartis Investigative Site

    RECRUITING

    Béziers, 34525, France

  • Novartis Investigative Site

    RECRUITING

    Cholet, 49325, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Grenoble, 38043, France

  • Novartis Investigative Site

    RECRUITING

    Lille, 59037, France

  • Novartis Investigative Site

    RECRUITING

    Montpellier, 34295, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75013, France

  • Novartis Investigative Site

    RECRUITING

    Pessac, 33604, France

  • Novartis Investigative Site

    RECRUITING

    Poitiers, 86021, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31054, France

  • Novartis Investigative Site

    RECRUITING

    Stuttgart, Baden-Wurttemberg, 70376, Germany

  • Novartis Investigative Site

    RECRUITING

    Potsdam, Brandenburg, 14473, Germany

  • Novartis Investigative Site

    RECRUITING

    Chemnitz, Saxony, 09113, Germany

  • Novartis Investigative Site

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 10789, Germany

  • Novartis Investigative Site

    RECRUITING

    Bielefeld, 33604, Germany

  • Novartis Investigative Site

    RECRUITING

    Gelnhausen, 63571, Germany

  • Novartis Investigative Site

    RECRUITING

    Mannheim, 68165, Germany

  • Novartis Investigative Site

    RECRUITING

    Münster, 48145, Germany

  • Novartis Investigative Site

    RECRUITING

    Singen, 78224, Germany

  • Novartis Investigative Site

    RECRUITING

    Hong Kong, Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    RECRUITING

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    RECRUITING

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    RECRUITING

    Caserta, CE, 81100, Italy

  • Novartis Investigative Site

    RECRUITING

    Grosseto, GR, 58100, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20138, Italy

  • Novartis Investigative Site

    RECRUITING

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    RECRUITING

    Perugia, PG, 06129, Italy

  • Novartis Investigative Site

    RECRUITING

    Pordenone, PN, 33170, Italy

  • Novartis Investigative Site

    RECRUITING

    Salerno, SA, 84131, Italy

  • Novartis Investigative Site

    RECRUITING

    Legnago, VR, 37045, Italy

  • Novartis Investigative Site

    RECRUITING

    The Hague, South Holland, 2545 AA, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Enschede, 7512KZ, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    RECRUITING

    Castilleja de la Cuesta, Sevilla, 41950, Spain

  • Novartis Investigative Site

    RECRUITING

    A Coruña, 15006, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08023, Spain

  • Novartis Investigative Site

    RECRUITING

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    RECRUITING

    Huelva, 21080, Spain

  • Novartis Investigative Site

    RECRUITING

    Las Palmas GC, 35010, Spain

  • Novartis Investigative Site

    RECRUITING

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46010, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46014, Spain

  • Novartis Investigative Site

    RECRUITING

    Changhua, 50006, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Tainan, 704, Taiwan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Chichester, West Sussex, PO19 6SE, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, EC1M 6BQ, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Tyne and Wear, NE29 8NH, United Kingdom

  • Ocala Cardiovascular Research

    RECRUITING

    Ocala, Florida, 34471, United States

  • Omega Clinical Research

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Overlook Medical Center

    RECRUITING

    Summit, New Jersey, 07901, United States

  • Parkway Medical Center

    ACTIVE_NOT_RECRUITING

    Birmingham, Alabama, 35215, United States

  • Peace River Cardiovascular Center

    RECRUITING

    Port Charlotte, Florida, 33952, United States

  • PharmaTex Research LLC

    RECRUITING

    Amarillo, Texas, 79106, United States

  • SEC Clinical Research

    RECRUITING

    Pensacola, Florida, 32503, United States

  • The Corvallis Clinic P C

    ACTIVE_NOT_RECRUITING

    Corvallis, Oregon, 97330, United States

  • University Of South Florida

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of Miami Hospital

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33136, 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

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