<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/NCT04487743</url>
  </required_header>
  <id_info>
    <org_study_id>202006108</org_study_id>
    <secondary_id>HDSJ19LLLT</secondary_id>
    <nct_id>NCT04487743</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Liraglutide on Body Weight in Obese Subjects or Overweight Subjects With Co-morbidities</brief_title>
  <official_title>Efficacy and Safety of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, 28-week Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiangya Hospital of Central South University</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>
      We performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300&#xD;
      non-diabetic obese subjects or overweight subjects with co-morbidities were randomly&#xD;
      assigned. Eligible participants were randomized 2:1 to once-daily subcutaneous injections of&#xD;
      either liraglutide or placebo. The primary outcome is to investigate the safety, tolerability&#xD;
      from baseline to end of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300&#xD;
      individuals (18-75 years of age, body-mass index ≥30 kg/m2 or BMI 27-30kg/m2 accompanied by&#xD;
      at least one weight-related complication (treated or untreated hypertension, dyslipidemia,&#xD;
      pre-diabetes)) were randomly assigned. All the patients provided written informed consent&#xD;
      before participation. Key exclusion criteria were type 1 or 2 diabetes, the use of&#xD;
      medications that cause clinically significant weight gain or loss, previous bariatric&#xD;
      surgery, a history of pancreatitis, a history of major depressive or other severe psychiatric&#xD;
      disorders, and a family or personal history of multiple endocrine neoplasia type 2 or&#xD;
      familial medullary thyroid carcinoma. Eligible participants were randomized 2:1 to once-daily&#xD;
      subcutaneous injections of either liraglutide or placebo using a computer-generated,&#xD;
      centrally administered procedure. Patients, investigators, and the sponsor were unaware of&#xD;
      the study-group assignments. The primary endpoint was change in bodyweight during the 28&#xD;
      weeks of the study in the intention-to-treat population. The proportion of people losing more&#xD;
      than 5% of baseline weight was also assessed. Secondary efficacy endpoints included the&#xD;
      proportion of people losing more than 10% of baseline weight was also assessed, change in&#xD;
      waist circumference, hip circumference, WHR, systolic and diastolic blood pressure, fasting&#xD;
      lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein&#xD;
      cholesterol, and triglycerides), glucose metabolism parameters (fasting plasma glucose,&#xD;
      2-hour post-challenge plasma glucose and glycosylated haemoglobin [HbA1c]).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 9, 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 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>Mean Change From Baseline in Fasting Body Weight</measure>
    <time_frame>Week 0, Week 28</time_frame>
    <description>mean change from baseline in fasting body weight (%) after 28-weeks of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Losing at Least 5% of Baseline Fasting Body Weight.</measure>
    <time_frame>Week 28</time_frame>
    <description>Percentage of subjects losing at least 5% of baseline fasting body weight after 28-weeks of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Losing More Than 10% of Baseline Fasting Body Weight.</measure>
    <time_frame>Week 28</time_frame>
    <description>Percentage of subjects losing &gt;10% of baseline fasting body weight after 28-weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Waist Circumference (cm)</measure>
    <time_frame>Week 0, Week 28</time_frame>
    <description>mean change from baseline in waist circumference (cm) after 28-weeks of treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Liraglutide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 28 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subject receiving placebo 3.0 mg subcutaneous (under the skin) injection once daily for 28 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide</intervention_name>
    <description>Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification</description>
    <arm_group_label>Liraglutide</arm_group_label>
    <other_name>S20200402</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>S20200301</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any trial-related activity takes place&#xD;
&#xD;
          -  Obesity (BMI ≥30.0 kg/m2); or overweight (BMI ≥27.0 kg/m2) with treated or untreated&#xD;
             co-morbid dyslipidemia (Low-density lipoprotein ≥3.38mmol/l (130 mg/dl), or&#xD;
             triglycerides ≥1.7mmol/l (150 mg/dl), or high-density lipoprotein &lt;1.04mmol/l (40&#xD;
             mg/dl) for males and &lt;1.30mmol/l (50 mg/dl) for females) and/or hypertension (Systolic&#xD;
             blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)&#xD;
&#xD;
          -  Age ≥18 years, ≤75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator&#xD;
&#xD;
          -  HbA1c ≥6.5% or fasting plasma glucose ≥7.0 mmol/l or 2-hour post-challenge plasma&#xD;
             glucose ≥11.1 mmol/liter (at screening)&#xD;
&#xD;
          -  less than 5 kg self-reported change during the previous 3 months&#xD;
&#xD;
          -  Previous treatment with GLP-1 receptor agonists (including liraglutide or exenatide)&#xD;
             within the last 3 months&#xD;
&#xD;
          -  Known or suspected hypersensitivity to trial product, related products or other GLP-1&#xD;
             receptor agonist&#xD;
&#xD;
          -  Diet attempts using herbal supplements or over-the-counter medications within 1 months&#xD;
             before screening, or use prescription drugs for weight loss within 3 months before&#xD;
             screening (for example: orlistat, fenfluramine, maindole ) Or lipid dissolving&#xD;
             injection (for example: lipolysis needle) treatment&#xD;
&#xD;
          -  Current or history of treatment with medications that may cause significant weight&#xD;
             gain, within 3 months prior to screening, including systemic corticosteroids (more&#xD;
             than 1 week),tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers&#xD;
             (e.g. imipramine, amitriptiline, mirtazapin, paroxetine, phenelzine, clorpromazine,&#xD;
             thioridazine, clozapine, lanzapine, valproic acid and its derivatives, and lithium)&#xD;
&#xD;
          -  A history of malignant tumors within 5 years before screening (except for fully&#xD;
             treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local&#xD;
             prostate cancer after radical resection, and ductal carcinoma in situ after radical&#xD;
             operation)&#xD;
&#xD;
          -  A history of severe heart disease is defined as: decompensated heart insufficiency&#xD;
             (NYHA III-IV), and/or a history of unstable angina within 6 months before screening,&#xD;
             and a history of myocardial infarction within 12 months&#xD;
&#xD;
          -  Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)&#xD;
&#xD;
          -  Suffer from gastrointestinal motility disorders or obstruction diseases, such as&#xD;
             gastroparesis, gastroesophageal reflux disease&#xD;
&#xD;
          -  Any lifetime history of a suicidal attempt or A history of any suicidal behavior in&#xD;
             the last month prior to randomization&#xD;
&#xD;
          -  A patient health questionnaire (PHQ-9) score of ≥15&#xD;
&#xD;
          -  Montreal Cognitive Assessment Scale (MoCA) score &lt;26 at screening;&#xD;
&#xD;
          -  Any suicidal ideation of type 4 or 5 on the Columbian Suicidality Severity Rating&#xD;
             Scale (C-SSRS) in the last month prior to randomization&#xD;
&#xD;
          -  Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as&#xD;
             thyroid-stimulating hormone &gt;6 mIU/liter or &lt;0.4 mIU/liter&#xD;
&#xD;
          -  Screening calcitonin ≥50 ng/liter&#xD;
&#xD;
          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial&#xD;
             medullary thyroid carcinoma (FMTC) or Personal history of non-familial medullary&#xD;
             thyroid carcinoma&#xD;
&#xD;
          -  History of chronic pancreatitis or idiopathic acute pancreatitis or amylase ≥ 3 times&#xD;
             the upper limit of normal value during screening&#xD;
&#xD;
          -  ALT or AST or TBiL&gt;3 times the upper limit of normal value during screening&#xD;
&#xD;
          -  Impaired renal function, defined as serum creatinine level ≥1.5mg/dL (132µmol/L) in&#xD;
             men or ≥1.4mg/dL (123µmol/L) in women at screening&#xD;
&#xD;
          -  Untreated or uncontrolled severe dyslipidemia, defined as blood LDL-C≥190mg/dl&#xD;
             (4.94mmol/L) and/or TG≥500mg/dl (5.65mmol/L) at screening&#xD;
&#xD;
          -  Uncontrolled treated/untreated hypertension (systolic blood pressure ≥160 mm Hg and/or&#xD;
             diastolic blood pressure ≥100 mm Hg)&#xD;
&#xD;
          -  Previous surgical treatment for obesity (excluding liposuction if performed &gt;1 year&#xD;
             before trial entry)&#xD;
&#xD;
          -  According to the investigator's judgment, those who have a surgical plan during the&#xD;
             trial period (except for minor operations)&#xD;
&#xD;
          -  Participated in any weight loss clinical trials within 3 months before screening, and&#xD;
             took any experimental drugs within 1 month (Re-screening is allowed once within the&#xD;
             limit of the recruitment period)&#xD;
&#xD;
          -  Known or suspected abuse of alcohol or narcotics within 6 months&#xD;
&#xD;
          -  Poor compliance with restrictions on diet and behavior during screening&#xD;
&#xD;
          -  Females of child-bearing potential who are pregnant, breast-feeding&#xD;
&#xD;
          -  Participants intend to become pregnant or are not using adequate contraceptive methods&#xD;
             or subjects who use hormonal contraceptives&#xD;
&#xD;
          -  The investigator considers that it is not suitable for participants (for example, the&#xD;
             investigator judges that severe obstructive sleep apnea will cause gastroesophageal&#xD;
             reflux).&#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>Jing Wu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Minxiang Lei</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jing Wu</last_name>
    <phone>+86-13574120508</phone>
    <email>wujing0731@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Wu</last_name>
      <phone>+86-13574120508</phone>
      <email>wujing0731@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</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>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</mesh_term>
  </intervention_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/NCT04487743
org study id: 202006108
secondary id: HDSJ19LLLT
nct id: NCT04487743
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300
      non-diabetic obese subjects or overweight subjects with co-morbidities were randomly
      assigned. Eligible participants were randomized 2:1 to once-daily subcutaneous injections of
      either liraglutide or placebo. The primary outcome is to investigate the safety, tolerability
      from baseline to end of treatment.
We performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300
      individuals (18-75 years of age, body-mass index ≥30 kg/m2 or BMI 27-30kg/m2 accompanied by
      at least one weight-related complication (treated or untreated hypertension, dyslipidemia,
      pre-diabetes)) were randomly assigned. All the patients provided written informed consent
      before participation. Key exclusion criteria were type 1 or 2 diabetes, the use of
      medications that cause clinically significant weight gain or loss, previous bariatric
      surgery, a history of pancreatitis, a history of major depressive or other severe psychiatric
      disorders, and a family or personal history of multiple endocrine neoplasia type 2 or
      familial medullary thyroid carcinoma. Eligible participants were randomized 2:1 to once-daily
      subcutaneous injections of either liraglutide or placebo using a computer-generated,
      centrally administered procedure. Patients, investigators, and the sponsor were unaware of
      the study-group assignments. The primary endpoint was change in bodyweight during the 28
      weeks of the study in the intention-to-treat population. The proportion of people losing more
      than 5% of baseline weight was also assessed. Secondary efficacy endpoints included the
      proportion of people losing more than 10% of baseline weight was also assessed, change in
      waist circumference, hip circumference, WHR, systolic and diastolic blood pressure, fasting
      lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein
      cholesterol, and triglycerides), glucose metabolism parameters (fasting plasma glucose,
      2-hour post-challenge plasma glucose and glycosylated haemoglobin [HbA1c]).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean Change From Baseline in Fasting Body Weight
time frame: Week 0, Week 28
description: mean change from baseline in fasting body weight (%) after 28-weeks of treatment.
measure: Percentage of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
time frame: Week 28
description: Percentage of subjects losing at least 5% of baseline fasting body weight after 28-weeks of treatment.
measure: Percentage of Subjects Losing More Than 10% of Baseline Fasting Body Weight.
time frame: Week 28
description: Percentage of subjects losing >10% of baseline fasting body weight after 28-weeks of treatment
measure: Mean Change From Baseline in Waist Circumference (cm)
time frame: Week 0, Week 28
description: mean change from baseline in waist circumference (cm) after 28-weeks of treatment
arm group label: Liraglutide
arm group type: Experimental
description: Subject receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 28 weeks.
arm group label: placebo
arm group type: Placebo Comparator
description: Subject receiving placebo 3.0 mg subcutaneous (under the skin) injection once daily for 28 weeks.
intervention type: Drug
intervention name: Liraglutide
description: Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
arm group label: Liraglutide
other name: S20200402
intervention type: Drug
intervention name: placebo
description: Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
arm group label: placebo
other name: S20200301
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jing Wu
role: Principal Investigator
affiliation: Xiangya Hospital of Central South University
last name: Minxiang Lei
role: Principal Investigator
affiliation: Xiangya Hospital of Central South University
last name: Jing Wu
phone: +86-13574120508
email: wujing0731@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Overweight
mesh term: Body Weight
mesh term: Liraglutide