<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04438096</url>
  </required_header>
  <id_info>
    <org_study_id>CVI-LM001-Ⅱ-01</org_study_id>
    <nct_id>NCT04438096</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CVI Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CVI Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if CVI-LM001 is effective and safe versus placebo&#xD;
      in drug-naive subjects with elevated LDL cholesterol. There will be 4 groups receiving 100mg,&#xD;
      200mg, 300 mg and placebo treatment for 12 weeks respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a phase II study in subjects with elevated LDL cholesterol. As designed, the&#xD;
      study will start with a 4-week, single-blind, placebo run-in period based on diet and&#xD;
      exercise interventions for screening eligible subjects. After run-in, eligibility is&#xD;
      confirmed with required laboratory tests at Day -1 prior to randomization. The eligible&#xD;
      subjects are randomly assigned to CVI-LM001 100 mg, 200 mg, 300mg QD group or placebo QD&#xD;
      group with ratio 1:1:1:1 to receive a 12-week double-blind treatment. After 12-week&#xD;
      treatment, all investigational compound and placebo should be discontinued, followed by 4&#xD;
      week for safety evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 15, 2020</start_date>
  <completion_date type="Anticipated">March 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percent change of LDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparison treatment-emergent adverse events of LM001 arms with placebo arm after 12 weeks of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percent change of Non-HDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Total Cholesterol (TC)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percent change of TC from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percent change of ApoB from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Triglyceride (TG)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percent change of TG from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percent change of hsCRP from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein（ a）(Lp(a))</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percent change of Lp(a) from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percent change of PCSK9 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percent change of Apo A1 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>100 mg</intervention_name>
    <description>One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks</description>
    <arm_group_label>100 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>200 mg</intervention_name>
    <description>Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks</description>
    <arm_group_label>200 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>300 mg</intervention_name>
    <description>Three 100 mg pills (QD) will be orally administered for 12 weeks</description>
    <arm_group_label>300 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Three placebo pills (QD) will be orally administered for 12 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  1. Aged 18-70 years, inclusive&#xD;
&#xD;
          -  2. Men and nonpregnant, nonlactating women&#xD;
&#xD;
          -  3. Hypercholesterolemic subjects with LDL-C level between 3.36mmol/L~4.88mmol/L at&#xD;
             screening, inclusive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Fasting TG ≥3.99 mmol/L before randomization&#xD;
&#xD;
          -  2. History of significant cardiovascular , renal, pulmonary and liver diseases&#xD;
&#xD;
          -  3. History of diabetes&#xD;
&#xD;
          -  4. ALT or AST&gt;1.5XULN at screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Que Liu, MDPhD</last_name>
    <role>Study Chair</role>
    <affiliation>CVI Pharmaceuticals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Que Liu, MD PhD</last_name>
    <phone>6194081058</phone>
    <email>que.liu@cvipharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jingwen Liu, PhD</last_name>
    <email>jingwen.liu2@cvipharma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The second affiliated hospital of zhejiang University school of medicine</name>
      <address>
        <city>Hangzhou</city>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JianAn Wang, MD</last_name>
      <phone>0571-87315001</phone>
      <email>wang_jian_an@tom.vip.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
    <mesh_term>Hyperlipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>lipid panel including LDL as well as safety data</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>July, 2021</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04438096
org study id: CVI-LM001-Ⅱ-01
nct id: NCT04438096
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
time frame: 12 weeks
description: The percent change of LDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
measure: From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events
time frame: 12 weeks
description: Comparison treatment-emergent adverse events of LM001 arms with placebo arm after 12 weeks of treatment
measure: Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
time frame: 12 weeks
description: The percent change of Non-HDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
measure: Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
time frame: 12 weeks
description: The percent change of TC from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
measure: Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
time frame: 12 weeks
description: The percent change of ApoB from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
measure: Percent Change From Baseline to Week 12 in Triglyceride (TG)
time frame: 12 weeks
description: The percent change of TG from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
measure: Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
time frame: 12 weeks
description: The percent change of hsCRP from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
measure: Percent Change From Baseline to Week 12 in Lipoprotein（ a）(Lp(a))
time frame: 12 weeks
description: The percent change of Lp(a) from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
measure: Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9)
time frame: 12 weeks
description: The percent change of PCSK9 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
measure: Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1)
time frame: 12 weeks
description: The percent change of Apo A1 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
arm group label: 100 mg
arm group type: Experimental
arm group label: 200 mg
arm group type: Experimental
arm group label: 300 mg
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: 100 mg
description: One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks
arm group label: 100 mg
intervention type: Drug
intervention name: 200 mg
description: Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks
arm group label: 200 mg
intervention type: Drug
intervention name: 300 mg
description: Three 100 mg pills (QD) will be orally administered for 12 weeks
arm group label: 300 mg
intervention type: Drug
intervention name: Placebo
description: Three placebo pills (QD) will be orally administered for 12 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Que Liu, MDPhD
role: Study Chair
affiliation: CVI Pharmaceuticals
last name: Que Liu, MD PhD
phone: 6194081058
email: que.liu@cvipharma.com
last name: Jingwen Liu, PhD
email: jingwen.liu2@cvipharma.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Hyperlipidemias
sharing ipd: Yes
ipd description: lipid panel including LDL as well as safety data
ipd info type: Study Protocol
ipd time frame: July, 2021