Clinical trial NCT06750341: Study of QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated LDL Cholesterol
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses of QLC7401 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia With Poorly Controlled Low-density Lipoprotein Cholesterol (LDL-C) Elevated on Optimized Lipid-lowering Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Primary Hypercholesterolemia or Mixed Hyperlipidemia
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 lactating.
* The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.

Primary outcomes:
measure: Percentage changes in LDL-C from baseline to Day 180 and Day 270
timeFrame: 80 days and 270 days
Secondary outcomes:
measure: Percentage changes in LDL-C from baseline at each subsequent visit to Day 360
timeFrame: 360 days
measure: Value changes in LDL-C from baseline at each subsequent visit to Day 360
timeFrame: 360 days
measure: Percentage changes in PCSK9 from baseline at each subsequent visit to Day 360
timeFrame: 360 days
measure: Value changes in PCSK9 from baseline at each subsequent visit to Day 360
timeFrame: 360 days
measure: Percentage changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360
timeFrame: 360 days
measure: Value changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360
timeFrame: 360 days
measure: Proportion of participants with LDL-C greater than 80% of baseline value at Day 180, Day 210, Day 270, and Day 360
timeFrame: 360 days
measure: Duration of treatment for participants to return to 80% of baseline value or greater LDL-C or PCSK9 protein
timeFrame: 360 days
measure: Proportion of participants who attained global lipid modification targets for level of ASCVD risk
timeFrame: 360 days
measure: Number of participants with adverse events and injection site reactions, with abnormal vital signs, abnormal physical examination, abnormal 12-ECG, abnormal laboratory assessments
timeFrame: 360 days
measure: ADA incidence
timeFrame: 360 days
Other outcomes:
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