<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/NCT04440345</url>
  </required_header>
  <id_info>
    <org_study_id>CIBI362B101</org_study_id>
    <nct_id>NCT04440345</nct_id>
  </id_info>
  <brief_title>Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects</brief_title>
  <official_title>Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovent Biologics (Suzhou) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovent Biologics (Suzhou) 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 trial is conducted in China. The aim of this trial is to investigate Safety,&#xD;
      Tolerability, PK and PD for Multiple Doses of IBI362 in Male and Female Subjects being&#xD;
      Overweight or with Obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">December 12, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 12, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of treatment adverse events</measure>
    <time_frame>From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)</time_frame>
    <description>The relationship of each adverse event to the investigational product was assessed by the investigator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-IBI362 Antibodies</measure>
    <time_frame>From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)</time_frame>
    <description>Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;</measure>
    <time_frame>From the first dose (Day 1 ) of study drug until 12 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;</measure>
    <time_frame>From the first dose (Day 1 ) of study drug until 12 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;</measure>
    <time_frame>From the first dose (Day 1 ) of study drug until 12 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Glucagon of IBI362 in overweight or obesity subjects;</measure>
    <time_frame>From the first dose (Day 1 ) of study drug until 12 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Insulin of IBI362 in overweight or obesity subjects;</measure>
    <time_frame>From the first dose (Day 1 ) of study drug until 12 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the C-peptide of IBI362 in overweight or obesity subjects;</measure>
    <time_frame>From the first dose (Day 1 ) of study drug until 12 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight from baseline</measure>
    <time_frame>Baseline (Day 1 ) and 12 week for groups</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Overweight or Obesity</condition>
  <arm_group>
    <arm_group_label>IBI362</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received dose 1 level of IBI362 administered as multiple subcutaneous doses.&#xD;
Participants received dose 2 level of IBI362 administered as multiple subcutaneous doses.&#xD;
Participants received dose 3 level of IBI362 administered as multiple subcutaneous doses.&#xD;
Participants received dose 4 level of IBI362 administered as multiple subcutaneous doses.&#xD;
Participants received dose 5 level of IBI362 administered as multiple subcutaneous doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received matching placebo dose regiments by subcutaneous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IBI362</intervention_name>
    <description>Administered by subcutaneous injection</description>
    <arm_group_label>IBI362</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered by subcutaneous injection</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have stable body weight for the past 12 weeks prior to screening&#xD;
&#xD;
          2. Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with&#xD;
             complication, or BMI≥28 kg/m²,inclusive at screening&#xD;
&#xD;
          3. Willing and agreeable to commit to the duration of the study and undergo study&#xD;
             procedures as instructed by the clinic staff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a diagnosis of type 2 diabetes&#xD;
&#xD;
          2. Have received prescription drugs or over the counter drugs that promote weight loss in&#xD;
             the past 3 months prior to screening&#xD;
&#xD;
          3. Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or&#xD;
             GCG(glucagon)receptor agonists before.&#xD;
&#xD;
          4. Surgical treatment for obesity&#xD;
&#xD;
          5. Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase&#xD;
             or lipase above 2 times UNR (upper normal range), triglycerides above 500 mg/dL&#xD;
&#xD;
          6. Have other medical conditions or medical history that make participation in the study&#xD;
             unsafe or which may interfere in the interpretation of the results of the study&#xD;
&#xD;
          7. Unwilling to comply with smoking and alcohol restrictions during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University people's hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 11, 2021</last_update_submitted>
  <last_update_submitted_qc>July 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</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>
  <!-- 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/NCT04440345
org study id: CIBI362B101
nct id: NCT04440345
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is conducted in China. The aim of this trial is to investigate Safety,
      Tolerability, PK and PD for Multiple Doses of IBI362 in Male and Female Subjects being
      Overweight or with Obesity.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of treatment adverse events
time frame: From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)
description: The relationship of each adverse event to the investigational product was assessed by the investigator.
measure: Number of Participants With Anti-IBI362 Antibodies
time frame: From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)
description: Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies.
measure: Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;
time frame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;
time frame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;
time frame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the Glucagon of IBI362 in overweight or obesity subjects;
time frame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the Insulin of IBI362 in overweight or obesity subjects;
time frame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the C-peptide of IBI362 in overweight or obesity subjects;
time frame: From the first dose (Day 1 ) of study drug until 12 week
measure: Change in body weight from baseline
time frame: Baseline (Day 1 ) and 12 week for groups
arm group label: IBI362
arm group type: Experimental
description: Participants received dose 1 level of IBI362 administered as multiple subcutaneous doses.
Participants received dose 2 level of IBI362 administered as multiple subcutaneous doses.
Participants received dose 3 level of IBI362 administered as multiple subcutaneous doses.
Participants received dose 4 level of IBI362 administered as multiple subcutaneous doses.
Participants received dose 5 level of IBI362 administered as multiple subcutaneous doses.
arm group label: placebo
arm group type: Placebo Comparator
description: Participants received matching placebo dose regiments by subcutaneous injection
intervention type: Drug
intervention name: IBI362
description: Administered by subcutaneous injection
arm group label: IBI362
intervention type: Drug
intervention name: Placebo
description: Administered by subcutaneous injection
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight