Primary Hypercholesterolemia or Mixed Hyperlipidemia
Conditions
Brief summary
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.
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
1. Male or female participants aged ≥18 years of age. 2. 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. 3. Fasting Total Cholesterol (TG) ≤400mg/dL (≤4.5mmol/L) at screening. 4. Stable lipid-lowering therapy for ≥4 weeks at randomization. 5. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Exclusion criteria
1. 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. 2. 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. 3. 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. 4. 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 Low Density Lipoprotein Cholesterol (LDL-C) | From baseline to Day 330 |
Secondary
| Measure | Time frame |
|---|---|
| Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C | Day 90 to Day 360 |
| Change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline | From baseline to Day 360 |
| Incidence of Treatment-Emergent Adverse Events (TEAEs | Throughout the study duration] |
Contacts
CONTACTJian an Wang, Doctorate
Outcome results
None listed