Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

• Status: Recruiting
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CVI Pharmaceuticals

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