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Cholesterol drug showdown: which one do patients actually take?

NCT ID NCT07468500

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will look at medical records from 3,600 people in Japan to see how well they follow their prescribed cholesterol-lowering medication. It compares two drugs, inclisiran and evolocumab, over 12 months. The goal is to understand real-world adherence, not to test new treatments.

What this could mean

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

Active substance
inclisiran and evolocumab
What this could lead to
If successful, this study could show which cholesterol-lowering drug patients are more likely to take regularly, helping doctors choose better treatments.
What could go wrong
This is an observational study using existing data, so it cannot prove cause and effect. Results may not apply to people outside Japan.

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

About 3,600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

Adult patients with dyslipidemia and/or hypercholesterolemia who initiated treatment with inclisiran or evolocumab in the period after first approval of inclisiran in 22-Nov-2023

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: The patients are included if they meet all the following criteria: 1. At least one prescription of inclisiran or evolocumab (140 mg Pens) during the identification period. 2. At least one diagnosis of dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) without suspicion flag during the look back period. 3. At least 18 years on the index date. 4. At least one claim record within the 210 days prior to the index date (excluding the index date). Exclusion Criteria: Those with any of the following criteria will be excluded. 1. Both prescription records of inclisiran and evolocumab 140 mg Pens on the index date. 2. At least one claim data for inclisiran or evolocumab 140 mg Pens within the 210 days prior to the index date (excluding the index date). 3. At least one claim data for evolocumab 420 mg Auto mini-dosers during the observation period. 4. Incomplete data for the one year (365 days) follow-up period due to loss to follow-up (the end of the observation period) or death. (only for adherence cohort).

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Conditions

The condition(s) this trial relates to.

Dyslipidemias familial hypercholesterolemia Hypercholesterolemia hyperlipidemia inherited lipid metabolism disorder

As listed by the trial registrant

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

Dyslipidemia Dyslipidemia, hypercholesterolemia Hypercholesterolemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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