Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

Phase

Condition

Hypercholesterolemia

Dyslipidemia

Elevated Triglycerides (Hypertriglyceridemia)

Treatment

N/A

Clinical Study ID

NCT04438096

CVI-LM001-Ⅱ-01

Ages 18-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

1. Aged 18-70 years, inclusive
1. Men and nonpregnant, nonlactating women
1. Hypercholesterolemic subjects with LDL-C level between 3.36mmol/L~4.88mmol/L atscreening, inclusive

Exclusion

Exclusion Criteria:

1. Fasting TG ≥3.99 mmol/L before randomization
1. History of significant cardiovascular , renal, pulmonary and liver diseases
1. History of diabetes
1. ALT or AST>1.5XULN at screening

Study Design

July 15, 2020

March 15, 2022

Study 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.

Connect with a study center

The second affiliated hospital of zhejiang University school of medicine
Hangzhou, 310009
China
Active - Recruiting

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