Hyperlipidemia
Conditions
Brief summary
The purpose of this study is to determine if CVI-LM001 is effective and safe versus placebo in drug-naive subjects with elevated LDL cholesterol. There will be 4 groups receiving 100mg, 200mg, 300 mg and placebo treatment for 12 weeks respectively.
Detailed description
This study is a phase II study in subjects with elevated LDL cholesterol. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects. After run-in, eligibility is confirmed with required laboratory tests at Day -1 prior to randomization. The eligible subjects are randomly assigned to CVI-LM001 100 mg, 200 mg, 300mg QD group or placebo QD group with ratio 1:1:1:1 to receive a 12-week double-blind treatment. After 12-week treatment, all investigational compound and placebo should be discontinued, followed by 4 week for safety evaluation.
Interventions
DRUG100 mg
One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks
DRUG200 mg
Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks
DRUG300 mg
Three 100 mg pills (QD) will be orally administered for 12 weeks
DRUGPlacebo
Three placebo pills (QD) will be orally administered for 12 weeks
Sponsors
CVI Pharmaceuticals
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 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 1\. Aged 18-70 years, inclusive * 2\. Men and nonpregnant, nonlactating women * 3\. Hypercholesterolemic subjects with LDL-C level between 3.36mmol/L\ 4.88mmol/L at screening, inclusive
Exclusion criteria
* 1\. Fasting TG ≥3.99 mmol/L before randomization * 2\. History of significant cardiovascular , renal, pulmonary and liver diseases * 3\. History of diabetes * 4\. ALT or AST\>1.5XULN at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | 12 weeks | The percent change of LDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment |
| From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events | 12 weeks | Comparison treatment-emergent adverse events of LM001 arms with placebo arm after 12 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB) | 12 weeks | The percent change of ApoB from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment |
| Percent Change From Baseline to Week 12 in Triglyceride (TG) | 12 weeks | The percent change of TG from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | 12 weeks | The percent change of hsCRP from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment |
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | 12 weeks | The percent change of Non-HDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment |
| Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9) | 12 weeks | The percent change of PCSK9 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment |
| Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1) | 12 weeks | The percent change of Apo A1 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment |
| Percent Change From Baseline to Week 12 in Lipoprotein（ a）(Lp(a)) | 12 weeks | The percent change of Lp(a) from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment |
| Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | 12 weeks | The percent change of TC from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment |
Countries
China
Contacts
Primary ContactQue Liu, MD PhD
Backup ContactJingwen Liu, PhD
Outcome results
None listed