<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/NCT04504370</url>
  </required_header>
  <id_info>
    <org_study_id>PB119301</org_study_id>
    <nct_id>NCT04504370</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects</brief_title>
  <acronym>PB119</acronym>
  <official_title>A Phase III, Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PegBio Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PegBio Co., Ltd.</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>
      A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of&#xD;
      24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study included a maximum 2-week screening period, a 4-week single-blind introduction&#xD;
      period, a 24-week double-blind treatment period, a 28-week open extension treatment period,&#xD;
      and a 4-week safety follow-up period.&#xD;
&#xD;
      At the end of the single-blind entry period, eligible subjects were randomly assigned to two&#xD;
      different administration groups in a 1:1 ratio and received a 24-week double-blind treatment.&#xD;
&#xD;
      All subjects who completed the double-blind treatment entered the open extension treatment&#xD;
      phase.Open extension treatment with subcutaneous injection of 150μg PB-119 once a week for 28&#xD;
      weeks.&#xD;
&#xD;
      Safety follow-up was conducted 4 weeks after the end of treatment/completion of early exit&#xD;
      visit in the open extension period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Actual">November 28, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</primary_completion_date>
  <phase>Phase 3</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>Change in HbA1c</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Change in HbA1c from baseline(week 1) to week 25</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c Below 7.0%</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Percentage of participants with HbA1c below 7.0% was evaluated at week 25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight (kg)</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Change from baseline (week 1) in body weight was evaluated at week 25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Change from baseline (week 1) in FPG was evaluated at week 25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">273</enrollment>
  <condition>Type 2 Diabetes Mellitus (T2DM)</condition>
  <arm_group>
    <arm_group_label>PB-119 once-weekly-subcutaneous injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PB119 (polyethylene glycol exenatide) is a long-acting GLP-1RA for injection, which will be administered 150μg once-weekly subcutaneously to patients in active drug group for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo once-weekly-subcutaneous injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>PB-119 150μg matched placebo which will be used in placebo group for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GLP-1 receptor agonist</intervention_name>
    <description>PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).</description>
    <arm_group_label>PB-119 once-weekly-subcutaneous injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.</description>
    <arm_group_label>Placebo once-weekly-subcutaneous injection</arm_group_label>
    <other_name>PB-119 Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 18~75 years old;&#xD;
&#xD;
          -  Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by&#xD;
             WHO1999；&#xD;
&#xD;
          -  18.5 kg/m2 &lt; BMI &lt; 40.0 kg/m2 at screening;&#xD;
&#xD;
          -  7.5% ≤ HbA1c ≤ 11.0% at screening;&#xD;
&#xD;
          -  7.0% ≤ HbA1c ≤ 10.5% when the random;&#xD;
&#xD;
          -  18.5 kg/m2 &lt; BMI &lt; 40.0 kg/m2 during screening and before randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  T1DM;&#xD;
&#xD;
          -  Continuous use of insulin for more than 14 days within 1 year before screening or&#xD;
             before randomization；&#xD;
&#xD;
          -  Treatment with any dipeptidylpeptidase 4 (DPP-4) inhibitor or glucose-dependent&#xD;
             insulin-stimulating peptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor&#xD;
             agonist prior to screening or randomized prior treatment；&#xD;
&#xD;
          -  Screening for any of the following heart diseases within the first 6 months or before&#xD;
             randomization；&#xD;
&#xD;
          -  Patients whose hypertension was not effectively controlled during screening or before&#xD;
             randomization (after resting ≥5 minutes, systolic blood pressure ≥160mmHg and/or&#xD;
             diastolic blood pressure ≥100mmHg)；&#xD;
&#xD;
          -  Serum amylase or lipase &gt;3×ULN or those with previous diagnosis of acute/chronic&#xD;
             pancreatitis were screened or randomly screened；&#xD;
&#xD;
          -  Screening for severe trauma or infection that may affect glycemic control within the&#xD;
             first month or before randomization；&#xD;
&#xD;
          -  A history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine&#xD;
             adenomatosis type 2 (MEN2)；&#xD;
&#xD;
          -  Known to be allergic or intolerant to the study drug or metformin；&#xD;
&#xD;
          -  Female subjects during pregnancy or lactation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhiguang Zhou, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central South University The Second Xiangya Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>WeiHong Song, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First People's Hospital of Chenzhou</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jing Yang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Shanxi Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bin Gao, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tang-Du Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lin Liao, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qianfoshan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>YanJun Wang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Minxiu Yao, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qingdao Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huige Shao, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changsha Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jingna Lin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jiarui Li, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cangzhou Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaohong Lin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ZhuZhou Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guixia Wang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jianhua Ma, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhinong Zhang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qiqihar First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central South University The Second Xiangya Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 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, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04504370
org study id: PB119301
nct id: NCT04504370
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of
      24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.
The study included a maximum 2-week screening period, a 4-week single-blind introduction
      period, a 24-week double-blind treatment period, a 28-week open extension treatment period,
      and a 4-week safety follow-up period.

      At the end of the single-blind entry period, eligible subjects were randomly assigned to two
      different administration groups in a 1:1 ratio and received a 24-week double-blind treatment.

      All subjects who completed the double-blind treatment entered the open extension treatment
      phase.Open extension treatment with subcutaneous injection of 150μg PB-119 once a week for 28
      weeks.

      Safety follow-up was conducted 4 weeks after the end of treatment/completion of early exit
      visit in the open extension period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in HbA1c
time frame: week 1, week 25
description: Change in HbA1c from baseline(week 1) to week 25
measure: HbA1c Below 7.0%
time frame: week 1, week 25
description: Percentage of participants with HbA1c below 7.0% was evaluated at week 25.
measure: Change in Body Weight (kg)
time frame: week 1, week 25
description: Change from baseline (week 1) in body weight was evaluated at week 25
measure: Change in Fasting Plasma Glucose (FPG)
time frame: week 1, week 25
description: Change from baseline (week 1) in FPG was evaluated at week 25
measure: Change in Body Mass Index
time frame: week 1, week 25
description: Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.
arm group label: PB-119 once-weekly-subcutaneous injection
arm group type: Experimental
description: PB119 (polyethylene glycol exenatide) is a long-acting GLP-1RA for injection, which will be administered 150μg once-weekly subcutaneously to patients in active drug group for 24 weeks.
arm group label: Placebo once-weekly-subcutaneous injection
arm group type: Placebo Comparator
description: PB-119 150μg matched placebo which will be used in placebo group for 24 weeks.
intervention type: Drug
intervention name: GLP-1 receptor agonist
description: PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).
arm group label: PB-119 once-weekly-subcutaneous injection
intervention type: Drug
intervention name: Placebo
description: PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
arm group label: Placebo once-weekly-subcutaneous injection
other name: PB-119 Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhiguang Zhou, MD,PhD
role: Principal Investigator
affiliation: Central South University The Second Xiangya Hospital
last name: WeiHong Song, MD,PhD
role: Principal Investigator
affiliation: First People's Hospital of Chenzhou
last name: Jing Yang, MD,PhD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Shanxi Medical University
last name: Bin Gao, MD,PhD
role: Principal Investigator
affiliation: Tang-Du Hospital
last name: Lin Liao, MD,PhD
role: Principal Investigator
affiliation: Qianfoshan Hospital
last name: YanJun Wang, MD,PhD
role: Principal Investigator
affiliation: Second Hospital of Jilin University
last name: Minxiu Yao, MD,PhD
role: Principal Investigator
affiliation: Qingdao Central Hospital
last name: Huige Shao, MD,PhD
role: Principal Investigator
affiliation: Changsha Central Hospital
last name: Jingna Lin, MD,PhD
role: Principal Investigator
affiliation: Tianjin People's Hospital
last name: Jiarui Li, MD,PhD
role: Principal Investigator
affiliation: Cangzhou Central Hospital
last name: Xiaohong Lin, MD,PhD
role: Principal Investigator
affiliation: ZhuZhou Central Hospital
last name: Guixia Wang, MD,PhD
role: Principal Investigator
affiliation: The First Hospital of Jilin University
last name: Jianhua Ma, MD,PhD
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Zhinong Zhang, MD,PhD
role: Principal Investigator
affiliation: Qiqihar First Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No