Study of QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With El… (NCT06750341) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated LDL Cholesterol
156 participantsStarted 2025-02
Plain-language summary
To evaluate the efficacy, safety, pharmacodynamics and immunogenicity of QLC7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female participants aged ≥18 years of age.
* Serum LDL-C ≥1.8mmol/L for ASCVD participants or ≥2.6mmol/L for other participants at screening.
* Fasting TG \<400mg/dL (\<4.5mmol/L) at screening.
* Stable lipid-lowering therapy for ≥4 weeks at randomization.
* Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Exclusion Criteria:
* Having the following diseases or treatment history: (1) cardiac function as defined by the New York Heart Association (NYHA) grade II-IV at screening or randomization or latest detected LVEF\<30%; (2) CVD events 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 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 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 l…
What they're measuring
1
Percentage changes in LDL-C from baseline to Day 180 and Day 270