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New shot could tame inherited high cholesterol

NCT ID NCT07450378

Disease control Sponsor: Qilu Pharmaceutical Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase III trial tests QLC7401, a new RNA-based drug, in 120 adults with heterozygous familial hypercholesterolemia (a genetic condition causing very high cholesterol). Participants already on cholesterol medication will receive either QLC7401 or a placebo injection. The study measures how much LDL ('bad') cholesterol drops and checks for side effects. If successful, it could offer a new way to control cholesterol in this high-risk group.

What this could mean

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

Active substance
QLC7401 (a small interfering RNA drug that targets PCSK9 to lower cholesterol)
What this could lead to
If it works, this could provide a new, convenient injection option to help control very high cholesterol in people with familial hypercholesterolemia.
What could go wrong
This is a Phase III trial, but results are not yet available. The drug may not lower cholesterol enough or could cause side effects. It is tested only in people already on other cholesterol medications.

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

About 120 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

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.

Ages

18 to 80 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: * Aged 18-80 years (inclusive) * Participants diagnosed with heterozygous familial hypercholesterolemia by Dutch Lipid Clinic * Network criteria or genetic testing; * Serum low density lipoprotein cholesterol ≥2.6 millimoles (mmol)/liter (L) at screening. * Fasting triglyceride \<4.5 mmol/L at screening. * Participants on lipid-lowering therapies should be on a stable dose for ≥4 weeks before screening with no planned medication or dose change during study participation. * Estimated glomerular filtration Rate (eGFR) \>30 mL/min/1.73 m². * Willing to provide informed consent. Exclusion Criteria: * New York Heart Association (NYHA) class III or IV heart failure. * Uncontrolled cardiac arrhythmia. * Cardiovascular Diseases within 3 months. * Uncontrolled hypertension. * Poorly controlled type 2 diabetes. * Significant liver or kidney disease. * Pregnancy or lactation. * Other conditions deemed unsuitable by investigator.

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Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia

As listed by the trial registrant

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

Heterozygous familial hypercholesterolemia (HEFH)

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.

More trials for these conditions

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