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New shot cuts bad cholesterol in asian heart patients

NCT ID NCT04765657

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called inclisiran in about 345 Asian patients who have heart disease or are at high risk and still have high LDL (bad) cholesterol despite taking statins. The goal is to see if inclisiran lowers LDL cholesterol more than a placebo over about 11 months, and to check its safety. Participants continue their usual diet and statins during the trial.

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

345 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Dec 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 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: -At screening participants with: ASCVD (including acute coronary syndrome (ACS), stable coronary heart disease, post revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack (TIA), and peripheral atherosclerosis) and Serum LDL-C ≥1.8 mmol/L (≥70 mg/dL) OR ASCVD high risk (LDL-C ≥4.9 mmol/L, diabetes, high 10-year ASCVD risk assessed by Chinese ASCVD Risk Assessment Flow Chart , or high risk per local guidelines with a target LDL-C of \<100 mg/dL) and Serum LDL-C ≥2.6 mmol/L (≥100 mg/dL) * Fasting triglyceride \< 400 mg/dL (\< 4.52 mmol/L) at screening. * Participants on statins should be receiving a maximally tolerated dose . Maximum tolerated dose is defined as the maximum dose of statin that can be taken on a regular basis without intolerable AE. Intolerance to any dose of statin must be documented as historical AEs attributed to the statin in question on the source documentation and on the Medical history page of the eCRF * Participants not receiving statin must have a documented evidence of intolerance to all doses of at least 2 different statins(or the corresponding local definition of complete intolerance to statins) * Participants following lifestyle modification should be on the therapy of LDL-C lowering (such as statin monotherapy, or statin incombination with ezetimibe) with a stable dose for ≥30 days before screening and have no planned medication or dose change during study participation. * Participants are willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures. Exclusion Criteria: * New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction \<25%. * Cardiac arrhythmia with clinical significance within 3 months prior to randomization that is not controlled by medication or via ablation. * Major adverse cardiovascular event within 3 months prior to randomization. * Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg prior to randomization despite antihypertensive therapy. * Calculated glomerular filtration rate ≤30 mL/min by estimated glomerular filtration rate (eGFR) using standardized clinical methodology. * Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years. * History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization. * Barrier method: Condom or Occlusive cap (e.g. diaphragm or cervical/vault caps). * Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

atherosclerotic cardiovascular disease Dyslipidemias Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

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

Hypercholesterolemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Lanzhou, Gansu, 730030, China

  • Novartis Investigative Site

    Foshan, Guangdong, 528000, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050000, China

  • Novartis Investigative Site

    Baotou, Inner Mongolia, 014040, China

  • Novartis Investigative Site

    Hohhot, Inner Mongolia, 010017, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 211166, China

  • Novartis Investigative Site

    Nantong, Jiangsu, 226000, China

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004, China

  • Novartis Investigative Site

    Xuzhou, Jiangsu, 221003, China

  • Novartis Investigative Site

    Changchun, Jilin, 130000, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Jinan, Shandong, 250013, China

  • Novartis Investigative Site

    Jinshan, Shanghai Municipality, 201508, China

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030002, China

  • Novartis Investigative Site

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    Tianjin, Tianjin Municipality, 300121, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310014, China

  • Novartis Investigative Site

    Beijing, 100034, China

  • Novartis Investigative Site

    Beijing, 100039, China

  • Novartis Investigative Site

    Beijing, 100050, China

  • Novartis Investigative Site

    Beijing, 100191, China

  • Novartis Investigative Site

    Shanghai, 200032, China

  • Novartis Investigative Site

    Shanghai, 200040, China

  • Novartis Investigative Site

    Shanghai, 200080, China

  • Novartis Investigative Site

    Shanghai, 200120, China

  • Novartis Investigative Site

    Tianjin, 300052, China

  • Novartis Investigative Site

    Tianjin, 300140, China

  • Novartis Investigative Site

    Xiamen, 361004, China

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169609, Singapore

  • Novartis Investigative Site

    Wŏnju, Gangwon-do, 26427, South Korea

  • Novartis Investigative Site

    Incheon, Korea, 405 760, South Korea

  • Novartis Investigative Site

    Seoul, Korea, 02841, South Korea

  • Novartis Investigative Site

    Seoul, Korea, 03080, South Korea

  • Novartis Investigative Site

    Seoul, Seoul, 06351, South Korea

  • Novartis Investigative Site

    Seoul, South Korea, 110-746, South Korea

  • Novartis Investigative Site

    Gwangju, 61469, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Kaohsiung City, 80756, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    Taipei, 11220, Taiwan

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