NCT07444086Not yet recruitingPhase 3
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
Evaluation of Efficacy and Safety of QLC7401 Monotherapy in Participants With Non-familial Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 510 (estimated)
- First submitted
- 23 Feb 2026
- Start date
- 5 Mar 2026
- Primary completion date
- 7 Oct 2027
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07444086
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 510
- From 5 Mar 2026 to the primary completion date, 7 Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of prohibited lipid-lowering drugs within specified washout periods.
Other illness
- History of AAtherosclerotic cardiovascular disease (ASCVD)(e.g., myocardial infarction, stroke).
- Uncontrolled hypertension (Systolic Blood Pressure ≥160 mmHg or (Diastolic Blood Pressure ≥100 mmHg).
- Significant liver or kidney disease.
- Other conditions deemed unsuitable by investigator.
Lab values
- Poorly controlled type 2 diabetes (Glycated Haemoglobin A1c \>8.0%).
Other
- Familial hypercholesterolemia.
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.