Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438096
• Other study ID #: CVI-LM001-?-01
• Status: Recruiting
• Phase: Phase 2
• Start date: July 15, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: June 2020
• Source: CVI Pharmaceuticals
• Contact: Que Liu, MD PhD
• Phone: 6194081058
• Email: que.liu[@]cvipharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 15, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• 100 mg
One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks
• 200 mg
Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks
• 300 mg
Three 100 mg pills (QD) will be orally administered for 12 weeks
• Placebo
Three placebo pills (QD) will be orally administered for 12 weeks

Locations

Country	Name	City	State
China	The second affiliated hospital of zhejiang University school of medicine	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
CVI Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)	The percent change of LDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment	12 weeks
Primary	From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events	Comparison treatment-emergent adverse events of LM001 arms with placebo arm after 12 weeks of treatment	12 weeks
Secondary	Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	The percent change of Non-HDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment	12 weeks
Secondary	Percent Change From Baseline to Week 12 in Total Cholesterol (TC)	The percent change of TC from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment	12 weeks
Secondary	Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)	The percent change of ApoB from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment	12 weeks
Secondary	Percent Change From Baseline to Week 12 in Triglyceride (TG)	The percent change of TG from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment	12 weeks
Secondary	Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)	The percent change of hsCRP from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment	12 weeks
Secondary	Percent Change From Baseline to Week 12 in Lipoprotein( a)(Lp(a))	The percent change of Lp(a) from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment	12 weeks
Secondary	Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9)	The percent change of PCSK9 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment	12 weeks
Secondary	Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1)	The percent change of Apo A1 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment	12 weeks