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Can a Twice-Yearly shot stop artery plaque from growing?

NCT ID NCT05360446

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Updated 3 times

Summary

This study tests whether inclisiran, a drug given as a shot every 6 months, can reduce plaque buildup in the heart's arteries when added to standard statin therapy. About 608 adults with mild artery blockages (less than 50%) and no prior heart events will be randomly assigned to inclisiran or a placebo. The main goal is to see if plaque volume shrinks over 24 months, as measured by a special CT scan.

What this could mean

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

Active substance
inclisiran (a drug that lowers cholesterol by blocking a protein in the liver)
What this could lead to
If it works, this could show that inclisiran helps slow or reduce artery plaque in people with early heart disease, potentially preventing future heart attacks.
What could go wrong
This is an early-stage Phase 3 trial with 608 people, so results may not apply to everyone. The drug may not shrink plaque enough to make a real difference, and side effects like injection-site reactions are possible.

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

609 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Oct 2026

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.

Inclusion Criteria: * Male or female ≥18 years or ≤80 years of age at signing of informed consent. * Fasting LDL-C local lab value at the Screening Visit of either i) ≥100 mg/dL (2.6 mmol/L) if on statin therapy but not on a maximally tolerated statin therapy; ii) ≥150 mg/dL (3.9mmol/L) if statin naive and without documented statin intolerance; or iii) ≥55 mg/dL (1.4 mmol/L) if on a stable (≥4 weeks) dose of maximally tolerated statin therapy or if statin intolerant. * Fasting LDL-C local lab value ≥55 mg/dL (1.4 mmol/L) at the assessment performed during the Statin Optimization Period 3 Visit for participants going through the Statin Optimization Period. * Participants having NOCAD without previous cardiovascular events: NOCAD is defined as:. 1. Participant with CT-adapted Leaman score \>5. and a diameter stenosis \<50% or 2. Participants with a CT-adapted Leaman score \>5, a diameter stenosis ≥50% but with FFRCT ≥0.76. * A standard of care CCTA may serve as the study baseline CCTA scan if it is performed within 3 months prior to the participant's Screening Visit and meets the inclusion criteria of FFRct \>0.8 and CT-adapted Leaman score \>5, which will be assessed by the Imaging Core Lab. * At the Baseline Visit, participants must be on a stable (≥4 weeks) dose of maximally tolerated statin therapy. Participants not on maximally tolerated statin therapy and who do not have documented statin intolerance can be screened but must enter the study via a Statin Optimization Period. * Fasting LDL-C lab value ≥55 mg/dL (1.4 mmol/L) at the Baseline Visit, measured at the central laboratory. If the Baseline and Screening Visits occur on the same day, then the LDL-C assessment will be assessed on the central laboratory sample. If a participant qualifies at Screening but the fasting central lab LDL-C value at the Baseline visit does not meet eligibility, then eligibility will be determined based on the central lab result. * Fasting triglycerides value \<400 mg/dL (4.52 mmol/L) based on the local lab results at the Screening visit and on the central lab results at the CCTA visit. Exclusion Criteria: * Previous cardiovascular events history including myocardial infarction (MI), or prior coronary revascularization \[percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)\]. * Planned revascularization (PCI) or (CABG). * Previous cerebrovascular events including: * Prior ischemic stroke thought not to be caused by atrial fibrillation, valvular heart disease or mural thrombus. * History of prior percutaneous or surgical carotid artery revascularization. * History of Peripheral Artery Disease (PAD): * Prior documentation of a resting ankle-brachial index \<0.85. * History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery. * Prior non-traumatic amputation of a lower extremity due to peripheral artery disease. * Cardiac disorders, including any of the following: * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, atrial fibrillation) within 3 months prior to randomization that is not controlled by medication or via ablation at the time of the Screening Visit. * Complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) prior to randomization. * Contraindication for CCTA (e.g., allergic reactions to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA Visit as assessed by the Imaging Core Lab. * Pacemaker or implantable cardioverter-defibrillator (ICD) in situ. * Systolic Left Ventricle Ejection Fraction \<30% at the Screening Visit. * Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization (assessed at the Screening Visit) despite antihypertensive therapy. * Heart failure New York Heart Association (NYHA) class III or class IV at the Screening Visit. * Renal insufficiency (eGFR \<30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit and at the Statin Optimization 3 Visit. * Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. * Local creatine kinase (CK) values of either, unless a more stringent threshold is mandated by a local regulatory authority * Local CK values ≥5x ULN at the Statin Optimization 3 Visit unless a more stringent threshold is mandated by a local regulatory authority * Participant with myopathy at the Statin Optimization 3 Visit.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder nonobstructive coronary artery disease Plaque, Atherosclerotic

As listed by the trial registrant

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

Coronary artery disease

Contacts and locations

Locations

  • Alaska Heart and Vascular

    Anchorage, Alaska, 99508, United States

  • Anderson Medical Research

    Ft. Washington, Maryland, 20744, United States

  • Aultman Hospital

    Canton, Ohio, 44710, United States

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610, United States

  • Cardio Metabolic Institute

    Somerset, New Jersey, 08873, United States

  • Cardiovascular Res Found

    Beverly Hills, California, 90210, United States

  • George Washington Univ Medical Ctr

    Washington D.C., District of Columbia, 20037, United States

  • Heart Center Research Llc

    Huntsville, Alabama, 35801, United States

  • Icahn School of Med at Mt Sinai

    New York, New York, 10029, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014, United States

  • Lundquist Inst BioMed at Harbor

    Torrance, California, 90509-2910, United States

  • Midwest Heart and Vascular Spec

    Overland Park, Kansas, 66211, United States

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • NorthShore University Health System

    Evanston, Illinois, 60201, United States

  • Novartis Investigative Site

    Caba, Buenos Aires, C1119ACN, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1428DCO, Argentina

  • Novartis Investigative Site

    Auchenflower, Queensland, 4066, Australia

  • Novartis Investigative Site

    Chemside, Queensland, 4032, Australia

  • Novartis Investigative Site

    Milton, Queensland, 4064, Australia

  • Novartis Investigative Site

    Leabrook, South Australia, 5068, Australia

  • Novartis Investigative Site

    Turnhout, Antwerpen, 2300, Belgium

  • Novartis Investigative Site

    Genk, Limburg, 3600, Belgium

  • Novartis Investigative Site

    Hasselt, Limburg, 3500, Belgium

  • Novartis Investigative Site

    Yvoir, Namur, 5530, Belgium

  • Novartis Investigative Site

    Aalst, Oost Vlaanderen, 9300, Belgium

  • Novartis Investigative Site

    Curitiba, Paraná, 80040-050, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

  • Novartis Investigative Site

    São Paulo, 01409-902, Brazil

  • Novartis Investigative Site

    North York, Ontario, M6B 3H7, Canada

  • Novartis Investigative Site

    Ottawa, Ontario, K1Y 4W7, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H1T 1C8, Canada

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8380465, Chile

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100013, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 211166, China

  • Novartis Investigative Site

    Beijing, 100050, China

  • Novartis Investigative Site

    Shanghai, 200080, China

  • Novartis Investigative Site

    Paris, 75013, France

  • Novartis Investigative Site

    Pessac, 33604, France

  • Novartis Investigative Site

    Poitiers, 86021, France

  • Novartis Investigative Site

    Toulouse, 31054, France

  • Novartis Investigative Site

    Budapest, H-1083, Hungary

  • Novartis Investigative Site

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    Bangalore, Karnataka, 560069, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110017, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600006, India

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641009, India

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226003, India

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001, India

  • Novartis Investigative Site

    New Delhi, 110025, India

  • Novartis Investigative Site

    Dublin, Ireland, D03 VX82, Ireland

  • Novartis Investigative Site

    Galway, H91 YR71, Ireland

  • Novartis Investigative Site

    Milan, MI, 20138, Italy

  • Novartis Investigative Site

    Milan, MI, 20157, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Torino, TO, 10126, Italy

  • Novartis Investigative Site

    Miyhazaki, Miyazaki, 8802102, Japan

  • Novartis Investigative Site

    Urasoe, Okinawa, 901-2102, Japan

  • Novartis Investigative Site

    Izumisano, Osaka, 5988577, Japan

  • Novartis Investigative Site

    Kyoto, 6078062, Japan

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620, South Korea

  • Novartis Investigative Site

    Goyang-si, Gyeonggi-do, 10380, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 07804, South Korea

  • Novartis Investigative Site

    A Coruña, 15006, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Geneva, 1211, Switzerland

  • Novartis Investigative Site

    Lugano, 6900, Switzerland

  • Novartis Investigative Site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

  • Novartis Investigative Site

    Edinburgh, EH16 4SA, United Kingdom

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Orion Medical

    Houston, Texas, 77034, United States

  • R Ins For Heart And Vascular Health

    Reno, Nevada, 89502, United States

  • Reid Physician Associates

    Richmond, Indiana, 47374, United States

  • Soltero Cardiovascular Research Center

    Dallas, Texas, 75226, United States

  • Stanford Health Care

    Stanford, California, 94305, United States

  • State Uni of NY at Stony Brook

    Stony Brook, New York, 11794-3362, United States

  • Swedish Medical Center-Cardiovascular Research

    Seattle, Washington, 98122, United States

  • UC San Diego Health

    La Jolla, California, 92037, United States

  • Univ of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Virginia Heart

    Falls Church, Virginia, 22042, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

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