Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

CVI Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Hyperlipidemia

Treatments: Drug: 100 mg; Drug: 300 mg; Drug: 200 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04438096

CVI-LM001-Ⅱ-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

100 mg

Experimental group

Treatment:

Drug: 100 mg

200 mg

Experimental group

Treatment:

Drug: 200 mg

300 mg

Experimental group

Treatment:

Drug: 300 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo