QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLC7401, Placebo.
- Who it may be relevant to
- Registry conditions: Primary Hypercholesterolemia or Mixed Hyperlipidemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug QLC7401
QLC7401 Injection - Drug Placebo
Placebo matching QLC7401 in appearance and administration.
Primary outcome measures
- Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline [Time frame: From baseline to Day 330]
Secondary outcome measures (3)
- Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) [Time frame: Day 90 to Day 360]
- Change in concentration of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline [Time frame: From baseline to Day 360]
- Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: From baseline to Day 360]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07444086 · QLC7401-303