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/NCT06040372</url>
    </required_header>
    <id_info>
      <org_study_id>LG-MCCL001</org_study_id>
      <nct_id>NCT06040372</nct_id>
    </id_info>
    <brief_title>A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects</brief_title>
    <official_title>Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Compound LB54640 in Healthy Overweight and Obese Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>LG Chem</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>LG Chem</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple&#xD;
        ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy&#xD;
        overweight and obese subjects&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was conducted in 2 parts:&#xD;
  &#xD;
        Part 1 (Single Ascending Dose) This study part included 6 sequential dose cohorts (S1-S6),&#xD;
        enrolling 8 healthy subjects per cohort. Cohort S3 was evaluate the effect of food.&#xD;
  &#xD;
        Part 2 (Multiple Ascending Dose) This part included 7 sequential dose cohorts (M1-M7),&#xD;
        enrolling 8 subjects per cohort. Cohorts was evaluate safety, Pharmacokinetics and&#xD;
        Pharmacodynamics parameters in healthy overweight and obese subjects. They were dosed once&#xD;
        daily for 28 days with LB54640 or placebo.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 16, 2020</start_date>
    <completion_date type="Actual">July 30, 2022</completion_date>
    <primary_completion_date type="Actual">March 30, 2022</primary_completion_date>
    <phase>Phase 1</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>This was a randomized, double-blind, placebo-controlled study conducted in two parts. Study Part 1 had a SAD design to investigate the safety, tolerability, and PK of LB54640 administered orally in healthy overweight and obese subjects. Study Part 1 included a cohort (Cohort S3) to assess the effect of food on LB54640, which was conducted with a blinded, placebo-controlled, two-way crossover design. Study Part 2 had a MAD design to investigate the safety, tolerability, PK, and PD of LB54640 administered orally in healthy overweight and obese subjects</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Double blind, there will be unblinded pharmacist for investigational product distribution.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence and severity of adverse events (AEs)</measure>
      <time_frame>Through study completion upto 6weeks depending on cohorts</time_frame>
      <description>Number of subjects who experienced adverse events and severity of adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence and severity of adverse events of special interest (AESIs) in Part 2 (MAD)</measure>
      <time_frame>Through study completion upto 6weeks depending on cohorts</time_frame>
      <description>Number of subjects who experienced adverse events of special interest (AESIs)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline in vital signs (blood pressure)</measure>
      <time_frame>Through study completion upto 6weeks depending on cohorts</time_frame>
      <description>Absolute values and changes from baseline (BP assessed by 24-hour ambulatory blood pressure monitoring (ABPM);systolic pressure and diastolic pressure will be assessed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline in vital signs (heart rate)</measure>
      <time_frame>Through study completion upto 6weeks depending on cohorts</time_frame>
      <description>Absolute values and changes from baseline (HR assessed by 24-hour ambulatory electrocardiography monitoring (12-lead cardiac telemetry; central reader))</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline in vital signs (weight in kilograms, height in meters)</measure>
      <time_frame>Through study completion upto 6weeks depending on cohorts</time_frame>
      <description>weight and height will be combined to report BMI in kg/m^2</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics profiles in Plasma for single ascending dose cohort</measure>
      <time_frame>Through study completion upto 1week</time_frame>
      <description>Peak Plasma Concentration (Cmax) during the dosing periods</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics profiles in Plasma for single ascending dose cohort</measure>
      <time_frame>Upto 1week</time_frame>
      <description>Area under the plasma concentration versus time curve (AUC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics profiles in Plasma for single ascending dose cohort</measure>
      <time_frame>Through study completion upto 1week during the single ascending dose cohort</time_frame>
      <description>Terminal half-life (t1/2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics profiles in urine for single ascending dose cohort</measure>
      <time_frame>upto 1week</time_frame>
      <description>Renal clearance (CLR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics profiles in urine for single ascending dose cohort</measure>
      <time_frame>Through study completion upto 1week depending on cohorts</time_frame>
      <description>Amount of unchanged drug excreted into urine (Ae) for specific collection intervals</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics profiles in plasma for multiple ascending dose cohort</measure>
      <time_frame>upto 2weeks</time_frame>
      <description>Maximum concentration (Cmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics profiles in plasma for multiple ascending dose cohort</measure>
      <time_frame>Through study completion upto 2weeks</time_frame>
      <description>Area under the concentration-time curve (AUC) during the dosing periods</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Effect of food by Pharmacokinetics profiles</measure>
      <time_frame>Through study completion upto 1week</time_frame>
      <description>Area under the concentration-time curve (AUC) (total and various incremental AUCs, including AUClast, AUC0-infinity)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">112</enrollment>
    <condition>Obese</condition>
    <condition>Overweight</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>LB54640</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>5 mg, 25 mg and 200 mg strengths&#xD;
  Subjects will be administered once daily and duration vary per each cohorts.&#xD;
  Single Ascending Dose (SAD) cohorts : 1 day&#xD;
  SAD 1 10mg&#xD;
  SAD 2 25mg&#xD;
  SAD 3 50mg (Food effect cohort)&#xD;
  SAD 4 100mg&#xD;
  SAD 5 200mg&#xD;
  SAD 6 400mg&#xD;
  healthy Multiple Ascending Dose (MAD) cohorts: 28days&#xD;
  MAD 1 10mg&#xD;
  MAD 2 25mg&#xD;
  MAD 3 50mg&#xD;
  MAD 4 100mg&#xD;
  MAD 5 200mg&#xD;
  MAD 6 400mg&#xD;
  MAD 7 600mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>matching placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LB64640</intervention_name>
      <description>The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.</description>
      <arm_group_label>LB54640</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo is provided as a matching placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults ≥ 18 to ≤ 70 years.&#xD;
  &#xD;
            -  Body mass index (BMI) ≥ 27 kg/m2, with stable body weight by history for 3 months&#xD;
               (defined as change &lt; 5%)&#xD;
  &#xD;
            -  HbA1c &lt; 6.5%.&#xD;
  &#xD;
            -  Female subjects must be non-pregnant and non-lactating. Females of childbearing&#xD;
               potential must use at least two of the medically accepted contraceptive methods, table&#xD;
               at least 4 weeks prior to the screening.&#xD;
  &#xD;
            -  Ability to provide written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History or current diagnosis with T1DM or T2DM.&#xD;
  &#xD;
            -  History or current diagnosis of any malignancy.&#xD;
  &#xD;
            -  History of pheochromocytoma or insulinoma.&#xD;
  &#xD;
            -  History or current diagnosis of cardiac dysrhythmias or heart disease&#xD;
  &#xD;
            -  History of surgical treatment for obesity or any other gastrointestinal surgery&#xD;
  &#xD;
            -  History of major depression, anxiety, suicidal behavior or attempts, or other&#xD;
               psychiatric disorder.&#xD;
  &#xD;
            -  Use of approved weight-lowering pharmacotherapy&#xD;
  &#xD;
            -  Has a clinically significant history of suicidal ideation or suicidal behavior as&#xD;
               assessed&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Victoria Mirza</last_name>
      <role>Principal Investigator</role>
      <affiliation>Clinical Research Unit</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Clinical Research Unit</name>
        <address>
          <city>Chula Vista</city>
          <state>California</state>
          <zip>91911</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 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>Overweight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06040372
  org study id: LG-MCCL001
  nct id: NCT06040372
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple
        ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy
        overweight and obese subjects
  The study was conducted in 2 parts:
  
        Part 1 (Single Ascending Dose) This study part included 6 sequential dose cohorts (S1-S6),
        enrolling 8 healthy subjects per cohort. Cohort S3 was evaluate the effect of food.
  
        Part 2 (Multiple Ascending Dose) This part included 7 sequential dose cohorts (M1-M7),
        enrolling 8 subjects per cohort. Cohorts was evaluate safety, Pharmacokinetics and
        Pharmacodynamics parameters in healthy overweight and obese subjects. They were dosed once
        daily for 28 days with LB54640 or placebo.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This was a randomized, double-blind, placebo-controlled study conducted in two parts. Study Part 1 had a SAD design to investigate the safety, tolerability, and PK of LB54640 administered orally in healthy overweight and obese subjects. Study Part 1 included a cohort (Cohort S3) to assess the effect of food on LB54640, which was conducted with a blinded, placebo-controlled, two-way crossover design. Study Part 2 had a MAD design to investigate the safety, tolerability, PK, and PD of LB54640 administered orally in healthy overweight and obese subjects
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Double blind, there will be unblinded pharmacist for investigational product distribution.
  measure: Incidence and severity of adverse events (AEs)
  time frame: Through study completion upto 6weeks depending on cohorts
  description: Number of subjects who experienced adverse events and severity of adverse events
  measure: Incidence and severity of adverse events of special interest (AESIs) in Part 2 (MAD)
  time frame: Through study completion upto 6weeks depending on cohorts
  description: Number of subjects who experienced adverse events of special interest (AESIs)
  measure: Change from baseline in vital signs (blood pressure)
  time frame: Through study completion upto 6weeks depending on cohorts
  description: Absolute values and changes from baseline (BP assessed by 24-hour ambulatory blood pressure monitoring (ABPM);systolic pressure and diastolic pressure will be assessed
  measure: Change from baseline in vital signs (heart rate)
  time frame: Through study completion upto 6weeks depending on cohorts
  description: Absolute values and changes from baseline (HR assessed by 24-hour ambulatory electrocardiography monitoring (12-lead cardiac telemetry; central reader))
  measure: Change from baseline in vital signs (weight in kilograms, height in meters)
  time frame: Through study completion upto 6weeks depending on cohorts
  description: weight and height will be combined to report BMI in kg/m^2
  measure: Pharmacokinetics profiles in Plasma for single ascending dose cohort
  time frame: Through study completion upto 1week
  description: Peak Plasma Concentration (Cmax) during the dosing periods
  measure: Pharmacokinetics profiles in Plasma for single ascending dose cohort
  time frame: Upto 1week
  description: Area under the plasma concentration versus time curve (AUC)
  measure: Pharmacokinetics profiles in Plasma for single ascending dose cohort
  time frame: Through study completion upto 1week during the single ascending dose cohort
  description: Terminal half-life (t1/2)
  measure: Pharmacokinetics profiles in urine for single ascending dose cohort
  time frame: upto 1week
  description: Renal clearance (CLR)
  measure: Pharmacokinetics profiles in urine for single ascending dose cohort
  time frame: Through study completion upto 1week depending on cohorts
  description: Amount of unchanged drug excreted into urine (Ae) for specific collection intervals
  measure: Pharmacokinetics profiles in plasma for multiple ascending dose cohort
  time frame: upto 2weeks
  description: Maximum concentration (Cmax)
  measure: Pharmacokinetics profiles in plasma for multiple ascending dose cohort
  time frame: Through study completion upto 2weeks
  description: Area under the concentration-time curve (AUC) during the dosing periods
  measure: Effect of food by Pharmacokinetics profiles
  time frame: Through study completion upto 1week
  description: Area under the concentration-time curve (AUC) (total and various incremental AUCs, including AUClast, AUC0-infinity)
  arm group label: LB54640
  arm group type: Experimental
  description: 5 mg, 25 mg and 200 mg strengths
  Subjects will be administered once daily and duration vary per each cohorts.
  Single Ascending Dose (SAD) cohorts : 1 day
  SAD 1 10mg
  SAD 2 25mg
  SAD 3 50mg (Food effect cohort)
  SAD 4 100mg
  SAD 5 200mg
  SAD 6 400mg
  healthy Multiple Ascending Dose (MAD) cohorts: 28days
  MAD 1 10mg
  MAD 2 25mg
  MAD 3 50mg
  MAD 4 100mg
  MAD 5 200mg
  MAD 6 400mg
  MAD 7 600mg
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: matching placebo
  intervention type: Drug
  intervention name: LB64640
  description: The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.
  arm group label: LB54640
  intervention type: Drug
  intervention name: Placebo
  description: Placebo is provided as a matching placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Victoria Mirza
  role: Principal Investigator
  affiliation: Clinical Research Unit
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Overweight
  sharing ipd: No