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Real-World study tracks cholesterol drug inclisiran in heart patients

NCT ID NCT06958315

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 1 time

Summary

This observational study follows about 198 patients in Spain who are already taking inclisiran (Leqvio) for high cholesterol linked to heart disease or a genetic condition. Researchers will check if patients reach their LDL cholesterol goals after 6 and 12 months. The goal is to see how the drug performs in everyday practice, outside of strict 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 (Leqvio)
What this could lead to
If successful, this study could show how well inclisiran works in everyday clinical practice, helping doctors better manage high cholesterol in patients with heart disease or genetic cholesterol disorders.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It does not test new treatments or prove cause and effect.

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

219 people

The number who actually took part.

Started

Jun 2025

Expected to finish

May 2027

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

Adults (≥18 years) with a confirmed clinical indication for inclisiran.

Ages

18 to 99 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. Aged ≥ 18 years. 2. Written signed informed consent form (ICF). 3. Patients with a confirmed clinical indication for inclisiran who have received the first dose of inclisiran, following clinical judgement, at least 2 months prior to the inclusion in the study. 4. Available assessment of LDL-C levels (mg/dL) within 6 months before inclisiran initiation. The measurement of LDL-C levels must be done after one month of stable LLT and without any modification from the testing up to inclisiran initiation. 5. Statin-intolerant patients are eligible if they had documented side effects on ≥2 statins, including one at the lowest dose. Exclusion Criteria: 1\. Participating in a clinical trial of a treatment that could modify LDL-C levels during the observational period of the study.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease familial hypercholesterolemia

As listed by the trial registrant

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

Atherosclerotic vascular disease Heterozygous familial hypercholesterolemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Cadiz, Andalusia, 11009, Spain

  • Novartis Investigative Site

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    Huelva, Andalusia, 21005, Spain

  • Novartis Investigative Site

    Jaén, Andalusia, 23007, Spain

  • Novartis Investigative Site

    Marbella, Andalusia, 29600, Spain

  • Novartis Investigative Site

    Mallorca, Balearic Islands, 07198, Spain

  • Novartis Investigative Site

    Puerto Real, Cadiz, 11510, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Andújar, Jaen, 23740, Spain

  • Novartis Investigative Site

    Logroño, La Rioja, 26006, Spain

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

  • Novartis Investigative Site

    Burgos, 09006, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Fuerteventura, 35600, Spain

  • Novartis Investigative Site

    Las Palmas GC, 35010, Spain

  • Novartis Investigative Site

    León, 24080, Spain

  • Novartis Investigative Site

    Málaga, 29010, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Seville, 41009, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

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