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New shot shows promise for lowering bad cholesterol

NCT ID NCT05763875

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new medicine called inclisiran in 350 people with high cholesterol who were not taking any other cholesterol drugs. The goal was to see if inclisiran could lower 'bad' LDL cholesterol more than a placebo or another drug called ezetimibe. Participants received either inclisiran, ezetimibe, or a placebo, and their cholesterol levels were measured after 150 days.

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

350 people

The number who actually took part.

Started

Mar 2023

Finished

Jun 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 at screening: * informed consent signed prior to participation in study * fasting LDL-C of \>= 100 mg/dL but \< 190 mg/dL * fasting triglycerides \<= 400 mg/dL * 10-year ASCVD risk score \< 7.5% * not on any lipid-lowering therapy within 90 days of screening Key Exclusion Criteria: * history of ASCVD * diabetes mellitus or fasting plasma glucose of \>= 7.0 mmol/L or HbA1c \>= 6.5% * secondary hypercholesterolemia, e.g. hypothyroidism (TSH above upper limit of normal)

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

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

Hypercholesterolemia

Contacts and locations

Locations

  • Alma Clinical Research Inc

    Miami, Florida, 33165, United States

  • ClinCloud

    Maitland, Florida, 32751, United States

  • Compass Point Research

    Nashville, Tennessee, 37203, United States

  • Conrad Clinical Research

    Edmond, Oklahoma, 73013, United States

  • Cozy Research LLC

    Zephyrhills, Florida, 33541, United States

  • Dominion Medical Associates

    Richmond, Virginia, 23219, United States

  • Fam Medical Specialists Of Fl Plc

    Plant City, Florida, 33563, United States

  • Grace Research LLC

    Bossier City, Louisiana, 71111, United States

  • Grace Research Llc

    Shreveport, Louisiana, 71101, United States

  • Harmony Clinical Research

    North Miami Beach, Florida, 33162, United States

  • Hillcrest Medical Research

    DeLand, Florida, 32720, United States

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014, United States

  • Koch Family Medicine

    Morton, Illinois, 61550, United States

  • Lillestol Research LLC

    Fargo, North Dakota, 58103, United States

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • Mt Olympus Medical Research

    Sugar Land, Texas, 77479, United States

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080012, Colombia

  • Novartis Investigative Site

    Floridablanca, Santander Department, 57-7, Colombia

  • Novartis Investigative Site

    Manizales, 170008, Colombia

  • Novartis Investigative Site

    San Gil, 684031, Colombia

  • Novartis Investigative Site

    Munich, Bavaria, 80809, Germany

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30449, Germany

  • Novartis Investigative Site

    Löhne, North Rhine-Westphalia, 32584, Germany

  • Novartis Investigative Site

    Jerichow, Saxony-Anhalt, 39319, Germany

  • Novartis Investigative Site

    Berlin, 10787, Germany

  • Novartis Investigative Site

    Bochum, 44789, Germany

  • Novartis Investigative Site

    Gladbeck, 45968, Germany

  • Novartis Investigative Site

    Hamburg, 22607, Germany

  • Novartis Investigative Site

    Papenburg, 26871, Germany

  • Novartis Investigative Site

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    Pécs, 7623, Hungary

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64060, Mexico

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64440, Mexico

  • Novartis Investigative Site

    Mérida, Yucatán, 97070, Mexico

  • Novartis Investigative Site

    Culiacan Sinaloa, 80230, Mexico

  • Novartis Investigative Site

    Querétaro, 76000, Mexico

  • Parkway Medical Center

    Birmingham, Alabama, 35215, United States

  • Prime Global Research Inc

    The Bronx, New York, 10456, United States

  • SEC Clinical Research

    Dothan, Alabama, 36305, United States

  • Southern Clin Research Clinic

    Zachary, Louisiana, 70791, United States

  • Spaulding Clinical Research

    West Bend, Wisconsin, 53095, United States

  • WellNow Urgent Care and Research

    Huber Heights, Ohio, 45424, United States

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