Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

Launched by CVI PHARMACEUTICALS · Jun 16, 2020

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility 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