Primary Hypercholesterolemia or Mixed Hyperlipidemia
Conditions
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.
Interventions
DRUGQLC7401
QLC7401 combined with lipid-lowering agents
DRUGPlacebo
Placebo combined with lipid-lowering agents
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage changes in LDL-C from baseline to Day 180 and Day 270 | 80 days and 270 days |
Secondary
| Measure | Time frame |
|---|---|
| Value changes in LDL-C from baseline at each subsequent visit to Day 360 | 360 days |
| Percentage changes in PCSK9 from baseline at each subsequent visit to Day 360 | 360 days |
| Value changes in PCSK9 from baseline at each subsequent visit to Day 360 | 360 days |
| 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 | 360 days |
| 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 | 360 days |
| Percentage changes in LDL-C from baseline at each subsequent visit to Day 360 | 360 days |
| Duration of treatment for participants to return to 80% of baseline value or greater LDL-C or PCSK9 protein | 360 days |
| Proportion of participants who attained global lipid modification targets for level of ASCVD risk | 360 days |
| Number of participants with adverse events and injection site reactions, with abnormal vital signs, abnormal physical examination, abnormal 12-ECG, abnormal laboratory assessments | 360 days |
| ADA incidence | 360 days |
| Proportion of participants with LDL-C greater than 80% of baseline value at Day 180, Day 210, Day 270, and Day 360 | 360 days |
Contacts
Primary ContactMing Zhao
Outcome results
None listed