Not Yet RecruitingPhase 3

QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

120 participantsStarted 2026-05

Plain-language summary

This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 Treatment in adults with Heterozygous Familial Hypercholesterolemia on a stable lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change in LDL-C from Baseline

Timeframe: From baseline to Day 360

Trial details

NCT IDNCT07450378

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Jie Lin, PhD

86 135 2183 6273 Linjie1998@126.com

View on ClinicalTrials.gov More Heterozygous Familial Hypercholesterolemia (HeFH) trials