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.
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.
| Condition | Hyperlipoproteinemia, Dyslipidemia, Dyslipidemia, Hyperlipidemia, High Cholesterol (Hyperlipidemia), High Cholesterol (Hyperlipidemia), hyperlipidaemia |
|---|---|
| Treatment | Placebo, CVI-LM001, 100 mg, 200 mg, 300 mg |
| Clinical Study Identifier | NCT04438096 |
| Sponsor | CVI Pharmaceuticals |
| Last Modified on | 1 July 2022 |
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