NCT04438096

Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: CVI Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	100 mg	One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks
DRUG	200 mg	Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks
DRUG	300 mg	Three 100 mg pills (QD) will be orally administered for 12 weeks
DRUG	Placebo	Three placebo pills (QD) will be orally administered for 12 weeks

Timeline

• Start date: 2020-07-15
• Primary completion: 2021-12-15
• Completion: 2022-03-15
• First posted: 2020-06-18
• Last updated: 2020-06-23

Locations

1 site across 1 country: China