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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg | Experimental |
| |
| 200 mg | Experimental |
| |
| 300 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg | Drug | One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks |
| |
| 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 |
| 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) |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Que Liu, MD PhD | Contact | 6194081058 | que.liu@cvipharma.com | |
| Jingwen Liu, PhD | Contact | jingwen.liu2@cvipharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Que Liu, MDPhD | CVI Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of zhejiang University school of medicine | Recruiting | Hangzhou | 310009 | China |
lipid panel including LDL as well as safety data
July, 2021
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 200 mg |
| Drug |
Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks |
|
| 300 mg | Drug | Three 100 mg pills (QD) will be orally administered for 12 weeks |
|
| Placebo | Drug | Three placebo pills (QD) will be orally administered for 12 weeks |
|
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 |