Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia
- Conditions
- Hyperlipidemia
- Interventions
- Drug: 300 mgDrug: 200 mgDrug: 100 mgDrug: Placebo
- Registration Number
- NCT04438096
- Lead Sponsor
- CVI Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
-
- Aged 18-70 years, inclusive
-
- Men and nonpregnant, nonlactating women
-
- Hypercholesterolemic subjects with LDL-C level between 3.36mmol/L~4.88mmol/L at screening, inclusive
-
- Fasting TG ≥3.99 mmol/L before randomization
-
- History of significant cardiovascular , renal, pulmonary and liver diseases
-
- History of diabetes
-
- ALT or AST>1.5XULN at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 300 mg 300 mg - 200 mg 200 mg - 100 mg 100 mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 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 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 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
Trial Locations
- Locations (1)
The second affiliated hospital of zhejiang University school of medicine
🇨🇳Hangzhou, China