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

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.

Study Overview

• Status: Unknown
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: 100 mg; Drug: 200 mg; Drug: 300 mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Que Liu, MD PhD; Phone Number: 6194081058; Email: que.liu@cvipharma.com
• Study Contact Backup: Name: Jingwen Liu, PhD; Email: jingwen.liu2@cvipharma.com

Study Locations

• China
  • Hangzhou, China, 310009
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Contact: JianAn Wang, MD; Phone Number: 0571-87315001; Email: wang_jian_an@tom.vip.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Three placebo pills (QD) will be orally administered for 12 weeks
EXPERIMENTAL: 100 mg	Drug: 100 mg; One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks
EXPERIMENTAL: 200 mg	Drug: 200 mg; Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks
EXPERIMENTAL: 300 mg	Drug: 300 mg; Three 100 mg pills (QD) will be orally administered for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: CVI Pharmaceuticals
• Investigators: Study Chair: Que Liu, MDPhD, CVI Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 15, 2020
• Primary Completion (ANTICIPATED): December 15, 2021
• Study Completion (ANTICIPATED): March 15, 2022

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: CVI-LM001-Ⅱ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: lipid panel including LDL as well as safety data
• IPD Sharing Time Frame: July, 2021
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No