Clinical trial NCT04438096: Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hyperlipidemia
Lead sponsor: CVI Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: 12 weeks
measure: From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: 12 weeks
measure: Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
timeFrame: 12 weeks
measure: Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
timeFrame: 12 weeks
measure: Percent Change From Baseline to Week 12 in Triglyceride (TG)
timeFrame: 12 weeks
measure: Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
timeFrame: 12 weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein（ a）(Lp(a))
timeFrame: 12 weeks
measure: Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9)
timeFrame: 12 weeks
measure: Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of zhejiang University school of medicine
Study officials:
affiliation: CVI Pharmaceuticals
name: Que Liu, MDPhD
role: STUDY_CHAIR
References: