Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

• ClinicalTrials.gov Identifier: NCT04438096
• Recruitment Status: Unknown
• First Posted: June 18, 2020
• Last Update Posted: June 23, 2020
• Sponsor: CVI Pharmaceuticals
• Information provided by (Responsible Party): CVI Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemia	Drug: 100 mg; Drug: 200 mg; Drug: 300 mg; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: July 15, 2020
• Estimated Primary Completion Date: December 15, 2021
• Estimated Study Completion Date: March 15, 2022

Arms and Interventions

Arm	Intervention/treatment
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
Placebo Comparator: Placebo	Drug: Placebo; Three placebo pills (QD) will be orally administered for 12 weeks

Outcome Measures

Primary Outcome Measures :

1. Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 12 weeks ]
   The percent change of LDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
2. From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events [ Time Frame: 12 weeks ]
   Comparison treatment-emergent adverse events of LM001 arms with placebo arm after 12 weeks of treatment

Secondary Outcome Measures :

1. Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: 12 weeks ]
   The percent change of Non-HDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
2. Percent Change From Baseline to Week 12 in Total Cholesterol (TC) [ Time Frame: 12 weeks ]
   The percent change of TC from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
3. Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB) [ Time Frame: 12 weeks ]
   The percent change of ApoB from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
4. Percent Change From Baseline to Week 12 in Triglyceride (TG) [ Time Frame: 12 weeks ]
   The percent change of TG from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
5. Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) [ Time Frame: 12 weeks ]
   The percent change of hsCRP from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
6. Percent Change From Baseline to Week 12 in Lipoprotein（ a）(Lp(a)) [ Time Frame: 12 weeks ]
   The percent change of Lp(a) from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
7. Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9) [ Time Frame: 12 weeks ]
   The percent change of PCSK9 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
8. Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1) [ Time Frame: 12 weeks ]
   The percent change of Apo A1 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Que Liu, MD PhD; 6194081058; que.liu@cvipharma.com

Contact: Jingwen Liu, PhD; jingwen.liu2@cvipharma.com

Locations

China

The second affiliated hospital of zhejiang University school of medicine; Recruiting

Hangzhou, China, 310009

Contact: JianAn Wang, MD 0571-87315001 wang_jian_an@tom.vip.com

Sponsors and Collaborators

CVI Pharmaceuticals

Investigators

• Study Chair: Que Liu, MDPhD; CVI Pharmaceuticals

More Information

• Responsible Party: CVI Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04438096
• Other Study ID Numbers: CVI-LM001-Ⅱ-01
• First Posted: June 18, 2020
• Last Update Posted: June 23, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: lipid panel including LDL as well as safety data
• Supporting Materials: Study Protocol
• Time Frame: July, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases