QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
New York Heart Association (NYHA) class III or IV heart failure.
Uncontrolled cardiac arrhythmia.
Cardiovascular Diseases within 3 months.
Uncontrolled hypertension.
Trial design
Design model
Parallel
Treatments tested in this trial
QLC7401 Injection
DrugQLC7401 is a small interfering RNA (siRNA) targeting PCSK9. Administered as subcutaneous injection at a specified dose level.
Placebo
DrugPlacebo matching QLC7401 in appearance and administration.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: QLC7401 InjectionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change in LDL-C from Baseline
Time frame
From baseline to Day 360Secondary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Time frame
From baseline to Day 360Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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