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/NCT05966272</url>
    </required_header>
    <id_info>
      <org_study_id>HRS9531-202</org_study_id>
      <nct_id>NCT05966272</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects</brief_title>
    <official_title>A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fujian Shengdi Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fujian Shengdi Pharmaceutical 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>
        To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo&#xD;
        in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who&#xD;
        have suboptimal glycaemic control after conventional lifestyle or metformin intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">September 9, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 12, 2024</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>
      <intervention_model_description>A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change From Baseline in HbA1c after 20 weeks of treatment</measure>
      <time_frame>Week 0 to Week 20</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects reaching HbA1c targets (HbA1c&lt;7.0%) after 20 weeks of treatment</measure>
      <time_frame>Week 0 to Week 20</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects reaching HbA1c targets (HbA1c&lt;7.0%) after 32 weeks of treatment</measure>
      <time_frame>Week 0 to Week 32</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in HbA1c after 32 weeks</measure>
      <time_frame>Week 0 to Week 32</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment</measure>
      <time_frame>Week 0 to Week 20</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment</measure>
      <time_frame>Week 0 to Week 32</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline body Weight and waist circumference after 20 weeks of treatment</measure>
      <time_frame>Week 0 to Week 20</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in body Weight and waist circumference after 32 weeks of treatment</measure>
      <time_frame>Week 0 to Week 32</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Anti-HRS9531 Antibody</measure>
      <time_frame>Week 0 to Week 36</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of AEs During the Trial</measure>
      <time_frame>Week 0 to Week 36</time_frame>
    </secondary_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>Treatment group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>HRS9531 injection dose level 1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>HRS9531 injection dose level 2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>HRS9531 injection dose level 3</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group D</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>HRS9531 injection dose level 4</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group E</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>HRS9531 injection Placebo dose level 1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group F</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>HRS9531 injection Placebo dose level 2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group G</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>HRS9531 injection Placebo dose level 3</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group H</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>HRS9531 injection Placebo dose level 4</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HRS9531 injection</intervention_name>
      <description>single dose</description>
      <arm_group_label>Treatment group A</arm_group_label>
      <arm_group_label>Treatment group B</arm_group_label>
      <arm_group_label>Treatment group C</arm_group_label>
      <arm_group_label>Treatment group D</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HRS9531 injection Placebo</intervention_name>
      <description>single dose</description>
      <arm_group_label>Treatment group E</arm_group_label>
      <arm_group_label>Treatment group F</arm_group_label>
      <arm_group_label>Treatment group G</arm_group_label>
      <arm_group_label>Treatment group H</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female subjects ,18-65 years of age, agreed and signed the informed consent&#xD;
  &#xD;
            2. Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.&#xD;
  &#xD;
            3. Treated with conventional lifestyle intervention and stable treatment with metformin&#xD;
               (≥1000 mg/day) at least 8 weeks prior to screening.&#xD;
  &#xD;
            4. HbA1c 7.5-10.5% (both inclusive) at screening visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Presence of any clinically significant results in examination at screening visit.&#xD;
  &#xD;
            2. Uncontrollable hypertension.&#xD;
  &#xD;
            3. A history of type 1 diabetes, specific diabetes, or secondary diabetes.&#xD;
  &#xD;
            4. Acute diabetic complications or severe hypoglycemia events within 12 months prior to&#xD;
               screening.&#xD;
  &#xD;
            5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to&#xD;
               screening.&#xD;
  &#xD;
            6. Any organ-system malignancies developed within 5 years except for cured local basal&#xD;
               cell carcinoma of the skin and carcinoma in situ of the cervix.&#xD;
  &#xD;
            7. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia,&#xD;
               or other more serious mental illness.&#xD;
  &#xD;
            8. Surgery is planned during the trial.&#xD;
  &#xD;
            9. Mentally incapacitated or speech-impaired.&#xD;
  &#xD;
           10. Pregnant or lactating woman.&#xD;
  &#xD;
           11. In the investigator's judgment, there were circumstances that affected subject safety&#xD;
               or otherwise interfered with the evaluation of results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hongcheng Hu</last_name>
      <phone>0518-82342973</phone>
      <email>hongcheng.hu@hengrui.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jianting Han</last_name>
      <phone>0518-82342973</phone>
      <email>jianting.han.jh27@hengrui.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shandong Provincial Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiajun Zhao, Doctor</last_name>
        <phone>+86-0531-87938911</phone>
        <email>jjzhao@sdu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</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/NCT05966272
  org study id: HRS9531-202
  nct id: NCT05966272
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo
        in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who
        have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Change From Baseline in HbA1c after 20 weeks of treatment
  time frame: Week 0 to Week 20
  measure: Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment
  time frame: Week 0 to Week 20
  measure: Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment
  time frame: Week 0 to Week 32
  measure: Change From Baseline in HbA1c after 32 weeks
  time frame: Week 0 to Week 32
  measure: Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment
  time frame: Week 0 to Week 20
  measure: Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment
  time frame: Week 0 to Week 32
  measure: Change from baseline body Weight and waist circumference after 20 weeks of treatment
  time frame: Week 0 to Week 20
  measure: Change from baseline in body Weight and waist circumference after 32 weeks of treatment
  time frame: Week 0 to Week 32
  measure: Number of Participants With Anti-HRS9531 Antibody
  time frame: Week 0 to Week 36
  measure: Number of AEs During the Trial
  time frame: Week 0 to Week 36
  arm group label: Treatment group A
  arm group type: Experimental
  description: HRS9531 injection dose level 1
  arm group label: Treatment group B
  arm group type: Experimental
  description: HRS9531 injection dose level 2
  arm group label: Treatment group C
  arm group type: Experimental
  description: HRS9531 injection dose level 3
  arm group label: Treatment group D
  arm group type: Experimental
  description: HRS9531 injection dose level 4
  arm group label: Treatment group E
  arm group type: Placebo Comparator
  description: HRS9531 injection Placebo dose level 1
  arm group label: Treatment group F
  arm group type: Placebo Comparator
  description: HRS9531 injection Placebo dose level 2
  arm group label: Treatment group G
  arm group type: Placebo Comparator
  description: HRS9531 injection Placebo dose level 3
  arm group label: Treatment group H
  arm group type: Placebo Comparator
  description: HRS9531 injection Placebo dose level 4
  intervention type: Drug
  intervention name: HRS9531 injection
  description: single dose
  arm group label: Treatment group A
  arm group label: Treatment group B
  arm group label: Treatment group C
  arm group label: Treatment group D
  intervention type: Drug
  intervention name: HRS9531 injection Placebo
  description: single dose
  arm group label: Treatment group E
  arm group label: Treatment group F
  arm group label: Treatment group G
  arm group label: Treatment group H
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Hongcheng Hu
  phone: 0518-82342973
  email: hongcheng.hu@hengrui.com
  last name: Jianting Han
  phone: 0518-82342973
  email: jianting.han.jh27@hengrui.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: Undecided