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Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

Primary Purpose

Hyperlipidemia

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

100 mg

200 mg

300 mg

Placebo

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The second affiliated hospital of zhejiang University school of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

100 mg

200 mg

300 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT04438096

First Posted

June 16, 2020

Last Updated

June 19, 2020

Sponsor

CVI Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04438096

Brief Title

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

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 15, 2020 (Anticipated)

Primary Completion Date

December 15, 2021 (Anticipated)

Study Completion Date

March 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CVI Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

100 mg

Arm Type

Experimental

Arm Title

200 mg

Arm Type

Experimental

Arm Title

300 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

100 mg

Intervention Description

One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks

Intervention Type

Drug

Intervention Name(s)

200 mg

Intervention Description

Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks

Intervention Type

Drug

Intervention Name(s)

300 mg

Intervention Description

Three 100 mg pills (QD) will be orally administered for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Three placebo pills (QD) will be orally administered for 12 weeks

Primary Outcome Measure Information:

Title

Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)

Description

The percent change of LDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Time Frame

12 weeks

Title

From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events

Description

Comparison treatment-emergent adverse events of LM001 arms with placebo arm after 12 weeks of treatment

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

Description

The percent change of Non-HDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Time Frame

12 weeks

Title

Percent Change From Baseline to Week 12 in Total Cholesterol (TC)

Description

The percent change of TC from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Time Frame

12 weeks

Title

Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)

Description

The percent change of ApoB from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Time Frame

12 weeks

Title

Percent Change From Baseline to Week 12 in Triglyceride (TG)

Description

The percent change of TG from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Time Frame

12 weeks

Title

Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)

Description

The percent change of hsCRP from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Time Frame

12 weeks

Title

Percent Change From Baseline to Week 12 in Lipoprotein（ a）(Lp(a))

Description

The percent change of Lp(a) from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Time Frame

12 weeks

Title

Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9)

Description

The percent change of PCSK9 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Time Frame

12 weeks

Title

Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1)

Description

The percent change of Apo A1 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Que Liu, MD PhD

Phone

6194081058

que.liu@cvipharma.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jingwen Liu, PhD

jingwen.liu2@cvipharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Que Liu, MDPhD

Organizational Affiliation

CVI Pharmaceuticals

Official's Role

Study Chair

Facility Information:

Facility Name

The second affiliated hospital of zhejiang University school of medicine

City

Hangzhou

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

JianAn Wang, MD

Phone

0571-87315001

wang_jian_an@tom.vip.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

lipid panel including LDL as well as safety data

IPD Sharing Time Frame

July, 2021

Learn more about this trial

Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

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