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New drug shows promise for lowering bad cholesterol without statins

NCT ID NCT05888103

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a drug called inclisiran in 207 Chinese adults with moderately high bad cholesterol (LDL-C) who were not taking other cholesterol medicines. Participants received either inclisiran or a placebo for 6 months, followed by 6 months where everyone got the drug. The main goal was to see how much inclisiran lowered LDL-C levels. The drug is designed to be taken long-term to control cholesterol, not to cure the condition.

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

207 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2024

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 75 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: * Written informed consent must be obtained before any assessment is performed. * Fasting LDL-C of ≥ 130 mg/dL but \< 190 mg/dL * Triglycerides ≤ 400 mg/dL * Categorized as low or moderate ASCVD risk by the 2016 Chinese Guideline Exclusion Criteria: * Use of any LLT within 90 days prior to screening visit * History of ASCVD * Diabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/L or HbA1c ≥ 6.5% * Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

atherosclerosis Hypercholesterolemia Plaque, Atherosclerotic

As listed by the trial registrant

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

Primary hypercholesterolemia or mixed dyslipidemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Jinzhou, Liaoning, 121001, China

  • Novartis Investigative Site

    Linyi, Shandong, 276000, China

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030002, China

  • Novartis Investigative Site

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Tianjin, Tianjin Municipality, 300121, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006, China

  • Novartis Investigative Site

    Beijing, 100029, China

  • Novartis Investigative Site

    Beijing, 100034, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Beijing, 101200, China

  • Novartis Investigative Site

    Jinan, 250012, China

  • Novartis Investigative Site

    Shanghai, 200025, 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

    Fuzhou, Fujian, 350025, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    Zhongshan, Guangdong, 528403, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Changsha, Hunan, 410003, China

  • Novartis Investigative Site

    Changsha, Hunan, 410011, China

  • Novartis Investigative Site

    Hohhot, Inner Mongolia, 010017, China

  • Novartis Investigative Site

    Changzhou, Jiangsu, 213004, China

  • Novartis Investigative Site

    Xuzhou, Jiangsu, 221003, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330009, China

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