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

NCT ID NCT05360446

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

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.

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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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