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/NCT05997576</url>
    </required_header>
    <id_info>
      <org_study_id>SYSA1803-013</org_study_id>
      <nct_id>NCT05997576</nct_id>
    </id_info>
    <brief_title>A Study of TG103 Injection in Non-diabetic Overweight or Obesity</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CSPC Baike (Shandong) Biopharmaceutical 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>
        This study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase 3&#xD;
        study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of&#xD;
        TG103 injection, a GLP-1 receptor agonist, for weight management in non-diabetic patients&#xD;
        with BMI greater than or equal to 28 kg/m2 or greater than 24 kg/m2 in the presence of&#xD;
        comorbidities, in addition to lifestyle intervention (calorie restrict diet and increased&#xD;
        physical activity).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2025</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of participants with weight loss of ≥ 5% at week 40</measure>
      <time_frame>From baseline to week 40</time_frame>
      <description>Weight loss is percentage change at week 40 compared with baseline.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Relative percentage change from baseline in body weight at week 40</measure>
      <time_frame>From baseline to week 40</time_frame>
      <description>Weight loss is percentage change at week 40 compared with baseline.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with weight loss of ≥ 5% at week 52</measure>
      <time_frame>From baseline to week 52</time_frame>
      <description>Weight loss is percentage change at week 52 compared with baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relative percentage change from baseline in body weight at week 52</measure>
      <time_frame>From baseline to week 52</time_frame>
      <description>Weight loss is percentage change at week 52 compared with baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with weight loss of ≥ 10%</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
      <description>Weight loss is percentage change at week 40 and week 52 compared with baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in body weight (kg)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in waist circumference (cm)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in HbA1c (%)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in fasting plasma glucose (mmol/L)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in fasting insulin (mU/L)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in total cholesterol (mmol/L)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in triglyceride (mmol/L)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in low density lipoprotein cholesterol (mmol/L)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in high density lipoprotein cholesterol (mmol/L)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in systolic blood pressure (mmHg)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in diastolic blood pressure (mmHg)</measure>
      <time_frame>From baseline to week 40, 52</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Number of TEAEs and SAEs assessed by CTCAE V5.0</measure>
      <time_frame>From baseline to week 55</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Proportion of participants categorized by patient health questionnaire-9 (PHQ-9) score</measure>
      <time_frame>From baseline to week 52</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Concentration of TG103 (Ctrough)</measure>
      <time_frame>From baseline to week 55</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Proportion of anti-TG103-antibody-positive participants</measure>
      <time_frame>From baseline to week 55</time_frame>
      <description>Plasma anti-TG103 antibody will be measured at baseline to establish a positive/negative cut-off point and during the study.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">675</enrollment>
    <condition>Overweight or Obesity</condition>
    <arm_group>
      <arm_group_label>TG103 22.5 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administered subcutaneously once every week for 52 weeks. Doses gradually increased to 22.5 mg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Administered subcutaneously once every week for 52 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TG103 22.5 mg</intervention_name>
      <description>Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.</description>
      <arm_group_label>TG103 22.5 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female, 18 years ≤ age ≤ 75 years.&#xD;
  &#xD;
            -  Body Mass Index (BMI) ≥ 28 kg/m^2, or 24 kg/m^2 &lt; BMI ≤ 28 kg/m^2 with at least one of&#xD;
               obesity-related complications.&#xD;
  &#xD;
            -  Regular diet and exercise and stable body weight (i.e., self-reported body weight&#xD;
               change &lt; 5%) within 12 weeks before screening as well as body weight ≥ 60 kg at&#xD;
               screening.&#xD;
  &#xD;
            -  Weight loss less than 5% or no weight loss after diet and exercise intervention for at&#xD;
               least 12 weeks.&#xD;
  &#xD;
            -  Be able to understand the trial and complete the procedures, and be voluntary to&#xD;
               participate in this study and sign the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of type 2 diabetes, type 1 diabetes or hypoglycemia.&#xD;
  &#xD;
            -  Overweight or obesity due to disease or drug; or weight increase due to non-fat mass&#xD;
               increase; or monogenic obesity.&#xD;
  &#xD;
            -  Medications or products which are judged by investigators to cause change in weight&#xD;
               and influence trial evaluations have been used within 12 weeks before screening or&#xD;
               will be used during study.&#xD;
  &#xD;
            -  Weight loss less than 5% by monotherapy or combination with GLP-1 receptor agonists&#xD;
               for at least 12 weeks before screening.&#xD;
  &#xD;
            -  Bariatric surgery within 12 months before screening; or no full recovery from any&#xD;
               surgery or injury at screening; or gastrointestinal motility dysfunction due to&#xD;
               gastrointestinal surgery.&#xD;
  &#xD;
            -  Participation in any clinical trial to receive treatment within 12 weeks before&#xD;
               screening, or participation in clinical trial to receive TG103 before screening.&#xD;
  &#xD;
            -  History of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents,&#xD;
               or suspected allergy to TG103 judged by investigator due to other severe allergy&#xD;
               history.&#xD;
  &#xD;
            -  Personal history or family history of medullary thyroid carcinoma or multiple&#xD;
               endocrine neoplasia syndrome type 2 (MEN-2).&#xD;
  &#xD;
            -  History or screening ultrasound reports of chronic pancreatitis, acute pancreatitis,&#xD;
               etc.&#xD;
  &#xD;
            -  History of severe gastrointestinal disease; or gastrointestinal symptom at screening;&#xD;
               or discontinuation of GLP-1 receptor agonist, GLP-1/GIP receptor agonist, GLP-1/GCG&#xD;
               receptor agonist or metformin due to gastrointestinal adverse reaction.&#xD;
  &#xD;
            -  Severe infection at screening.&#xD;
  &#xD;
            -  Skin disorder that influences safety evaluation at screening.&#xD;
  &#xD;
            -  History of severe disease or malignant tumor.&#xD;
  &#xD;
            -  Systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg, NYHA Grade&#xD;
               Ⅲ-Ⅳ, QTc interval prolongation or severe arrhythmia at screening.&#xD;
  &#xD;
            -  History of abnormal thyroid function with requirement of medication treatment at&#xD;
               screening, or screening TSH beyond the normal reference range.&#xD;
  &#xD;
            -  One of the followings at screening: 1) HbA1c ≥ 6.5%, or screening FPG ≥ 7.0mmol/L&#xD;
               or&lt;2.8mmol/L; 2) calcitonin ≥ 50 ng/L; 3) ALT or AST&gt;3 × UNL (upper normal limit), or&#xD;
               total bilirubin&gt;1.5 × UNL; 4) blood amylase or lipase&gt;1.5 × UNL, 5) TG&gt;5.6mmol/L, 6)&#xD;
               eGFR&lt;60ml/min/1.73m2 , 7) positive of HBsAg, HCV-antibody, HIV-antibody or anti-TP&#xD;
               antibody, 8) WBC&lt; 3×10^9/L, or Hb &lt;100g/L, 9) INR&gt;1.2.&#xD;
  &#xD;
            -  History of drug abuse, drug dependence or alcoholism.&#xD;
  &#xD;
            -  History of moderate to severe depression, or screening Patient Health Questionaire-9&#xD;
               (PHQ-9) score ≥ 15.&#xD;
  &#xD;
            -  The fertile female who is pregnant, breast-feeding or with blood HCG positive at&#xD;
               screening; or the fertile participants and their partner cannot use an effective&#xD;
               contraceptive method during the trial and within 3 months after the end of treatment.&#xD;
  &#xD;
            -  Other situations unsuitable for this study in the investigator's opinion.&#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>Li Yan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun Yat-sen Memorial Hospital,Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>officer Clinical Trials Information Group</last_name>
      <phone>86-0311-69085587</phone>
      <email>ctr-contact@cspc.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinical Trials Information Group</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <zip>050011</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Information Group officer</last_name>
        <phone>86-0311-69085587</phone>
        <email>ctr-contact@cspc.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>Obesity</mesh_term>
      <mesh_term>Overweight</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/NCT05997576
  org study id: SYSA1803-013
  nct id: NCT05997576
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase 3
        study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of
        TG103 injection, a GLP-1 receptor agonist, for weight management in non-diabetic patients
        with BMI greater than or equal to 28 kg/m2 or greater than 24 kg/m2 in the presence of
        comorbidities, in addition to lifestyle intervention (calorie restrict diet and increased
        physical activity).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Proportion of participants with weight loss of ≥ 5% at week 40
  time frame: From baseline to week 40
  description: Weight loss is percentage change at week 40 compared with baseline.
  measure: Relative percentage change from baseline in body weight at week 40
  time frame: From baseline to week 40
  description: Weight loss is percentage change at week 40 compared with baseline.
  measure: Proportion of participants with weight loss of ≥ 5% at week 52
  time frame: From baseline to week 52
  description: Weight loss is percentage change at week 52 compared with baseline.
  measure: Relative percentage change from baseline in body weight at week 52
  time frame: From baseline to week 52
  description: Weight loss is percentage change at week 52 compared with baseline.
  measure: Proportion of participants with weight loss of ≥ 10%
  time frame: From baseline to week 40, 52
  description: Weight loss is percentage change at week 40 and week 52 compared with baseline.
  measure: Change from baseline in body weight (kg)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in waist circumference (cm)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in HbA1c (%)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in fasting plasma glucose (mmol/L)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in fasting insulin (mU/L)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in total cholesterol (mmol/L)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in triglyceride (mmol/L)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in low density lipoprotein cholesterol (mmol/L)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in high density lipoprotein cholesterol (mmol/L)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in systolic blood pressure (mmHg)
  time frame: From baseline to week 40, 52
  measure: Change from baseline in diastolic blood pressure (mmHg)
  time frame: From baseline to week 40, 52
  measure: Number of TEAEs and SAEs assessed by CTCAE V5.0
  time frame: From baseline to week 55
  measure: Proportion of participants categorized by patient health questionnaire-9 (PHQ-9) score
  time frame: From baseline to week 52
  measure: Concentration of TG103 (Ctrough)
  time frame: From baseline to week 55
  measure: Proportion of anti-TG103-antibody-positive participants
  time frame: From baseline to week 55
  description: Plasma anti-TG103 antibody will be measured at baseline to establish a positive/negative cut-off point and during the study.
  arm group label: TG103 22.5 mg
  arm group type: Experimental
  description: Administered subcutaneously once every week for 52 weeks. Doses gradually increased to 22.5 mg.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Administered subcutaneously once every week for 52 weeks.
  intervention type: Drug
  intervention name: TG103 22.5 mg
  description: Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.
  arm group label: TG103 22.5 mg
  intervention type: Drug
  intervention name: Placebo
  description: Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Li Yan
  role: Principal Investigator
  affiliation: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
  last name: officer Clinical Trials Information Group
  phone: 86-0311-69085587
  email: ctr-contact@cspc.cn
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Obesity
  mesh term: Overweight
  sharing ipd: Undecided