Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

Hyperlipidemia Clinical Trial

Official title: A Randomized, Double-Blind, Parallel Group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of CVI-LM001 in Patients With Hypercholesterolemia

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

• NCT number: NCT04438096
• Study type: Interventional
• Source: CVI Pharmaceuticals
• Contact: Que Liu, MD PhD
• Phone: 6194081058
• Email: que.liu@cvipharma.com
• Status: Recruiting
• Phase: Phase 2
• Start date: July 15, 2020
• Completion date: March 15, 2022