Not Yet RecruitingPhase 3

QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

510 participantsStarted 2026-03-05

Plain-language summary

This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving 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

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 years. * Fasting low density lipoprotein cholesterol (LDL-C) ≥2.6 mmol/L and \<4.9 mmol/L at screening. * Atherosclerotic cardiovascular disease (ASCVD) risk stratification as low or intermediate risk per Chinese guidelines. * Not currently on lipid-lowering therapy. * estimated Glomerular Filtration Rate (eGFR) \>30 mL/min/1.73 m². * Willing to provide informed consent. Exclusion Criteria: * History of AAtherosclerotic cardiovascular disease (ASCVD)(e.g., myocardial infarction, stroke). * Familial hypercholesterolemia. * Uncontrolled hypertension (Systolic Blood Pressure ≥160 mmHg or (Diastolic Blood Pressure ≥100 mmHg). * Poorly controlled type 2 diabetes (Glycated Haemoglobin A1c \>8.0%). * Use of prohibited lipid-lowering drugs within specified washout periods. * 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 Low Density Lipoprotein Cholesterol (LDL-C) from Baseline

Timeframe: From baseline to Day 330

Trial details

NCT IDNCT07444086

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-07

Contact for this trial

Yue Li, PhD

8613945057313 hydy_liyue@163.com

View on ClinicalTrials.gov More Primary Hypercholesterolemia or Mixed Hyperlipidemia trials