About this trial
To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged ≥18 years of age.
Serum low density lipoprotein cholesterol (LDL-C) ≥1.8mmol/L for participants with atherosclerotic cardiovascular disease (ASCVD) or ≥2.6mmol/L for other participants at screening.
Fasting Total Cholesterol (TG) ≤400mg/dL (≤4.5mmol/L) at screening.
Stable lipid-lowering therapy for ≥4 weeks at randomization.
Disqualifiers
Having the following diseases or treatment history: (1) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization ; (2) Cardiovascular diseases within 3 months; (3) uncontrolled severe hypertension; (4) previous diagnosis of familial hypercholesterolemia; (5) have known allergic reaction to experimental drug, or have severe allergic reaction to other drugs; (6) inadequate organ functions or malignancy history; (7) prior exposure to other RNA inhibitors within 2 years.
Any of the laboratory indicators met the following criteria at screening or at randomization: (1) ALT or AST exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times ULN; (2) creatine kinase (CK) exceeding 3 times ULN; (3) TSH is less than the lower limit or normal (LLN) or exceeds 1.5 times ULN.
General conditions: (1) male or female participants who do not agree to use high-efficiency contraceptives during the trial and for 6 months after the last dosing; (2) women who are pregnant or lactating.
The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.
Trial design
Parallel
Treatments tested in this trial
QLC7401
DrugQLC7401 combined with lipid-lowering agents
Placebo
DrugPlacebo combined with lipid-lowering agents
Treatment groups
Trial outcomes
Primary outcomes
Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)
Secondary outcomes
Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C
Change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline
Incidence of Treatment-Emergent Adverse Events (TEAEs
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: