QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
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 Injection, Placebo.
- Who it may be relevant to
- Registry conditions: Heterozygous Familial Hypercholesterolemia (HeFH). Basic parameters: 18 years — 80 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 in Participants With Heterozygous Familial Hypercholesterolemia on a Stable Lipid-lowering Therapy: 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 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.
Interventions
- Drug QLC7401 Injection
QLC7401 is a small interfering RNA (siRNA) targeting PCSK9. Administered as subcutaneous injection at a specified dose level. - Drug Placebo
Placebo matching QLC7401 in appearance and administration.
Primary outcome measures
- Percent Change in LDL-C from Baseline [Time frame: From baseline to Day 360]
Secondary outcome measures (1)
- Incidence of Treatment-Emergent Adverse Events [Time frame: From baseline to Day 360]
Eligibility criteria
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.
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
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07450378 · QLC7401-304