xml: <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/NCT06009393</url>
    </required_header>
    <id_info>
      <org_study_id>SHR-1918-202</org_study_id>
      <nct_id>NCT06009393</nct_id>
    </id_info>
    <brief_title>Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia</brief_title>
    <official_title>A Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Suncadia Pharmaceuticals Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Suncadia Pharmaceuticals Co., Ltd</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-arm, open-label study to assess the reduction of low-density lipoprotein&#xD;
        cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia&#xD;
        (HoFH).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 24, 2023</start_date>
    <completion_date type="Anticipated">August 18, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 23, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percent change in calculated LDL-C from baseline to week 12</measure>
      <time_frame>from baseline to week 12</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in calculated LDL-C from baseline to week 12</measure>
      <time_frame>from baseline to week 12</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Homozygous Familial Hypercholesterolemia</condition>
    <arm_group>
      <arm_group_label>SHR-1918</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SHR-1918</intervention_name>
      <description>Three administration</description>
      <arm_group_label>SHR-1918</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the&#xD;
               protocol&#xD;
  &#xD;
            2. LDL-C ≥2.6mmol/L at the screening visit&#xD;
  &#xD;
            3. Body weight ≥40 kg&#xD;
  &#xD;
            4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening&#xD;
               (HbA1c &gt; 8.5%)&#xD;
  &#xD;
            2. eGFR &lt;30ml/min/1.73m2 at the screening visit&#xD;
  &#xD;
            3. CK &gt;5times ULN at the screening visit&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Meng Sun</last_name>
      <phone>+86 18036618718</phone>
      <email>meng.sun@hengrui.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</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>Hyperlipoproteinemia Type II</mesh_term>
      <mesh_term>Homozygous Familial Hypercholesterolemia</mesh_term>
      <mesh_term>Hypercholesterolemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009393
  org study id: SHR-1918-202
  nct id: NCT06009393
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-arm, open-label study to assess the reduction of low-density lipoprotein
        cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia
        (HoFH).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percent change in calculated LDL-C from baseline to week 12
  time frame: from baseline to week 12
  measure: Change in calculated LDL-C from baseline to week 12
  time frame: from baseline to week 12
  arm group label: SHR-1918
  arm group type: Experimental
  intervention type: Drug
  intervention name: SHR-1918
  description: Three administration
  arm group label: SHR-1918
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meng Sun
  phone: +86 18036618718
  email: meng.sun@hengrui.com
  responsible party type: Sponsor
  mesh term: Hyperlipoproteinemia Type II
  mesh term: Homozygous Familial Hypercholesterolemia
  mesh term: Hypercholesterolemia
  sharing ipd: Undecided