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New cholesterol drug inclisiran tested in everyday patients

NCT ID NCT05399992

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows about 847 adults with high cholesterol or mixed dyslipidemia who are starting inclisiran, a newer cholesterol-lowering drug. Researchers want to see how much LDL cholesterol drops after 10 months and how well patients stick with the treatment in real-world settings. The goal is to understand if inclisiran works effectively outside of controlled clinical trials.

What this could mean

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

Active substance
inclisiran
What this could lead to
If successful, this study could show that inclisiran effectively lowers LDL cholesterol in routine care, helping doctors manage high cholesterol more conveniently.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only looks at short-term adherence and cholesterol changes, not long-term health outcomes.

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.

Participants

847 people

The number who actually took part.

Started

Sep 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.

Who is studied

The study population will consist of adult participants with an underlying diagnosis of Atherosclerotic Cardiovascular Disease (ASCVD), ASCVD risk equivalent (ASCVD RE), or Heterozygous familial hypercholesterolemia (HeFH) and elevated levels of Low density lipoprotein - Cholesterol (LDL-C)

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: 1. Participants who are 18 years or older 2. Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH 3. Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines 4. Participants who per physician's criteria need to optimize their LLT 5. Participants who provide written informed consent to participate in the study 6. Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation. Exclusion Criteria: 1. Participants that have received inclisiran previously 2. Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)

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Conditions

The condition(s) this trial relates to.

hyperlipidemia, familial combined, LPL related

As listed by the trial registrant

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

Mixed dyslipidemia Primary hypercholesterolemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Feldkirch, 6807, Austria

  • Novartis Investigative Site

    Graz, 8036, Austria

  • Novartis Investigative Site

    Linz, 4021, Austria

  • Novartis Investigative Site

    Sankt Veit im Pongau, 5621, Austria

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Vienna, 1180, Austria

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518000, China

  • Novartis Investigative Site

    Holon, Gush Dan, 5845997, Israel

  • Novartis Investigative Site

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    Tel Aviv, 6801296, Israel

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50470, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 50400, Malaysia

  • Novartis Investigative Site

    Riyadh, Saudi, 11643, Saudi Arabia

  • Novartis Investigative Site

    Jeddah, 23311, Saudi Arabia

  • Novartis Investigative Site

    Tabuk, 47512, Saudi Arabia

  • Novartis Investigative Site

    Fribourg, CH, 1708, Switzerland

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Geneva, 1211, Switzerland

  • Novartis Investigative Site

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    Olten, 4600, Switzerland

  • Novartis Investigative Site

    Sankt Gallen, 9007, Switzerland

  • Novartis Investigative Site

    Zurich, 8032, Switzerland

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Abu Dhabi, Abu Dhabi Emirate, 00000, United Arab Emirates

  • Novartis Investigative Site

    Dubai, United Arab Emirates, 7272, United Arab Emirates

  • Novartis Investigative Site

    Abu Dhabi, United Arab Emirates

  • Novartis Investigative Site

    Al Ain City, United Arab Emirates

  • Novartis Investigative Site

    Dubai, United Arab Emirates

  • Novartis Investigative Site

    High Wycombe, Buckinghamshire, HP11 2TR, United Kingdom

  • Novartis Investigative Site

    Louth, Lincolnshire, LN11 7QU, United Kingdom

  • Novartis Investigative Site

    Sunderland, Tyne and Wear, SR4 7TP, United Kingdom

  • Novartis Investigative Site

    Belfast, BT16 1RH, United Kingdom

  • Novartis Investigative Site

    Bromwich, B71 4HJ, United Kingdom

  • Novartis Investigative Site

    Burton-on-Trent, DE13 0RB, United Kingdom

  • Novartis Investigative Site

    Cardiff, CF14 4XW, United Kingdom

  • Novartis Investigative Site

    Hull, HU3 2RW, United Kingdom

  • Novartis Investigative Site

    Lancaster, LA1 4RP, United Kingdom

  • Novartis Investigative Site

    Liverpool, L7 8XP, United Kingdom

  • Novartis Investigative Site

    London, NW3 2QG, United Kingdom

  • Novartis Investigative Site

    Middlesex, UB9 6JH, United Kingdom

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