Trial | NCT04438096  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    cvi-lm001 ...

  • Study Participants

    200
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.
Study Started
Jul 15
2020
Anticipated
Primary Completion
Dec 15
2021
Anticipated
Study Completion
Mar 15
2022
Anticipated
Last Update
Jun 23
2020

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

100 mg Experimental

200 mg Experimental

300 mg Experimental

Placebo Placebo Comparator

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
No Results Posted