<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/NCT03244800</url>
  </required_header>
  <id_info>
    <org_study_id>D5670C00011</org_study_id>
    <nct_id>NCT03244800</nct_id>
  </id_info>
  <brief_title>A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.</brief_title>
  <official_title>A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Different Doses of MEDI0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedImmune LLC</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 Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety&#xD;
      and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM).&#xD;
      Approximately 63 subjects will be enrolled across two cohorts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomised, double-blind, placebo-controlled study designed to evaluate the&#xD;
      efficacy, safety, tolerability, and pharmacokinetics of different doses of MEDI0382&#xD;
      administered as multiple SC doses to subjects with T2DM. Approximately 63 subjects will be&#xD;
      enrolled across two cohorts.&#xD;
&#xD;
      For cohort 1, sufficient subjects will be invited to participate in the study such that a&#xD;
      maximum of 39 subjects will complete dosing. Subjects in cohort 1 will be randomised using a&#xD;
      ratio of 2:1 to one of 2 treatment arms to receive either MEDI0382 or placebo. A maximum of&#xD;
      26 will complete dosing in the active arm and 13 will complete dosing in the placebo arm.&#xD;
&#xD;
      For cohort 2, sufficient subjects will be invited to participate in the study such that a&#xD;
      maximum of 24 subjects will complete dosing. Subjects in cohort 2 will be randomised using a&#xD;
      ratio of 3:1 to receive either MEDI0382 or placebo. A maximum of 18 will complete dosing in&#xD;
      the active arm and 6 will complete dosing in the placebo arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">January 23, 2018</completion_date>
  <primary_completion_date type="Actual">January 23, 2018</primary_completion_date>
  <phase>Phase 2</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>Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49</measure>
    <time_frame>Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal</time_frame>
    <description>The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 1: Percent Change From Baseline in Body Weight to Day 50</measure>
    <time_frame>Day 1 through Day 50</time_frame>
    <description>The percent change in body weight from baseline to Day 50 is reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49</measure>
    <time_frame>Baseline (Day -1) through Day 49</time_frame>
    <description>The change from baseline in Glycated haemoglobin (HbA1c) to Day 49 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49</measure>
    <time_frame>Baseline (Day -1) through Day 49</time_frame>
    <description>The changes in the fasting plasma glucose level during the study period from baseline to Day 49 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Change From Baseline in Body Weight to Day 50</measure>
    <time_frame>Day 1 through Day 50</time_frame>
    <description>The changes in the body weight during the study period from baseline to Day 50 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50</measure>
    <time_frame>Day 1 through Day 50</time_frame>
    <description>Participants achieving greater than or equal to 5% body weight loss from baseline to Day 50 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7</measure>
    <time_frame>Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal</time_frame>
    <description>The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) evaluation to Day 7 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first doses of study drug through 7 to 14 days after the last dose of study drug (approximately 64 days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs</measure>
    <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
    <description>Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, heart rate, body temperature, and respiration rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs</measure>
    <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
    <description>Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs</measure>
    <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
    <description>An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema</measure>
    <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
    <description>The injection site reactions observed during study visits were reported. Injection site reactions included (but are not limited to) local erythema, pain, tenderness, induration, swelling, pruritus, ulceration, and pigmentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382</measure>
    <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
    <description>The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382</measure>
    <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
    <description>The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382</measure>
    <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
    <description>The maximum observed concentration of MEDI0382 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382</measure>
    <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
    <description>The maximum observed concentration of MEDI0382 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382</measure>
    <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
    <description>The time to reach the maximum observed concentration of MEDI0382 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382</measure>
    <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
    <description>The time to reach the maximum observed concentration of MEDI0382 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Terminal Half Life (t1/2) of MEDI0382</measure>
    <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
    <description>The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Terminal Half Life (t1/2) of MEDI0382</measure>
    <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
    <description>The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Accumulation Ratio (Racc) of MEDI0382</measure>
    <time_frame>Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
    <description>The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 22 and Day 49. Racc was calculated using the formula, Racc of Day 49 = AUCt of Day 49/AUCt of Day 22.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Accumulation Ratio of MEDI0382</measure>
    <time_frame>Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
    <description>The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 1, Day 7 and Day 14. Racc was calculated using the formulas: Racc of Day 7 = AUCt of Day 7/AUCt of Day 1; Racc of Day 14 = AUCt of Day 14/AUCt of Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382</measure>
    <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
    <description>Trough plasma concentration is the measured concentration from the plasma concentration-time data at the end of a dosing interval at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382</measure>
    <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
    <description>Trough plasma concentration is the measured concentration from the plasma concentration time data at the end of a dosing interval at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382</measure>
    <time_frame>Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])</time_frame>
    <description>Participants with positive serum antibodies to MEDI0382 are reported.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Placebo Cohort 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo matching with MEDI0382 subcutaneously once daily for 49 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI0382 Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLacebo Cohort 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo matching with MEDI0382 subcutaneously once daily for 49 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI0382 Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI0382</intervention_name>
    <description>MEDI0382 will be administered subcutaneously once daily for 49 days.</description>
    <arm_group_label>MEDI0382 Cohort 1</arm_group_label>
    <arm_group_label>MEDI0382 Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be administered subcutaneously once daily for 49 days.</description>
    <arm_group_label>PLacebo Cohort 2</arm_group_label>
    <arm_group_label>Placebo Cohort 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects aged ≥ 18 years at screening&#xD;
&#xD;
          2. Provision of signed and dated written informed consent&#xD;
&#xD;
          3. BMI between 27 and 40 kg/m2&#xD;
&#xD;
          4. HbA1c range of 6.5% to 8.5%&#xD;
&#xD;
          5. Diagnosed with T2DM with glucose control managed with metformin monotherapy where no&#xD;
             significant dose change (increase or decrease ≥ 500 mg/day) has occurred in the 3&#xD;
             months prior to screening&#xD;
&#xD;
          6. Subjects prescribed oral dual therapy with a dipeptidyl peptidase-4 inhibitor,&#xD;
             sulphonylurea, glitinide, or a sodium-glucose co-transporter 2 inhibitor in addition&#xD;
             to metformin at screening may be eligible to enter the study following a 4-week&#xD;
             washout period&#xD;
&#xD;
          7. Female subjects of childbearing potential must have a negative pregnancy test at&#xD;
             screening and randomisation, and must not be lactating&#xD;
&#xD;
          8. Females of childbearing potential who are sexually active with a nonsterilised male&#xD;
             partner must use at least one highly effective method of contraception from screening&#xD;
             and must agree to continue using such precautions through to the end of the study. It&#xD;
             is strongly recommended for the male partner of a female subject to also use male&#xD;
             condom plus spermicide throughout this period. Cessation of contraception after this&#xD;
             point should be discussed with a responsible physician. Periodic abstinence, the&#xD;
             rhythm method, and the withdrawal method are not acceptable methods of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of, or any existing condition that, in the opinion of the investigator, would&#xD;
             interfere with evaluation of the investigational product, put the subject at risk,&#xD;
             influence the subject's ability to participate or affect the interpretation of the&#xD;
             results of the study and/or any subject unable or unwilling to follow study procedures&#xD;
&#xD;
          2. Concurrent participation in another study of any kind and repeat randomisation in this&#xD;
             study is prohibited&#xD;
&#xD;
          3. Severe allergy/hypersensitivity to any of the proposed study treatments&#xD;
&#xD;
          4. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight&#xD;
             loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the&#xD;
             subject has been treated with daily SC insulin within 90 days prior to screening&#xD;
&#xD;
          5. Significant inflammatory bowel disease, gastroparesis, or other severe disease or&#xD;
             surgery affecting the upper GI tract (including weight-reducing surgery and&#xD;
             procedures) which may affect gastric emptying or could affect the interpretation of&#xD;
             safety and tolerability data&#xD;
&#xD;
          6. Significant hepatic disease (except for non-alcoholic steatohepatitis or non-alcoholic&#xD;
             fatty liver disease without portal hypertension or cirrhosis) and/or subjects with any&#xD;
             of the following results at screening:&#xD;
&#xD;
               -  Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)&#xD;
&#xD;
               -  Alanine transaminase (ALT) ≥ 3 × ULN&#xD;
&#xD;
               -  Total bilirubin ≥ 2 × ULN&#xD;
&#xD;
          7. Impaired renal function defined as estimated glomerular filtration rate (GFR) &lt; 60&#xD;
             mL/minute/1.73 m2 at screening (GFR estimated according to Modification of Diet in&#xD;
             Renal Disease [MDRD] using the isotope dilution mass spectrometry [IDMS] traceable&#xD;
             MDRD Study Equation [SI units])&#xD;
&#xD;
          8. Poorly controlled hypertension defined as:&#xD;
&#xD;
               -  Systolic BP &gt; 160 mm Hg&#xD;
&#xD;
               -  Diastolic BP ≥ 95 mm Hg after 10 minutes of seated rest and confirmed by repeated&#xD;
                  measurement at screening.&#xD;
&#xD;
          9. Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke&#xD;
             within 3 months prior to screening, or subjects who have undergone percutaneous&#xD;
             coronary intervention or a coronary artery bypass graft within the past 6 months or&#xD;
             who are due to undergo these procedures at the time of screening&#xD;
&#xD;
         10. Severe congestive heart failure (New York Heart Association Class III or IV)&#xD;
&#xD;
         11. Basal calcitonin level &gt; 50 ng/L at screening or history/family history of medullary&#xD;
             thyroid carcinoma or multiple endocrine neoplasia&#xD;
&#xD;
         12. Haemoglobinopathy, haemolytic anemia, or chronic anaemia (haemoglobin concentration &lt;&#xD;
             11.5 g/dL [115 g/L] for males, &lt; 10.5 g/dL [105 g/L] for females) at screening or any&#xD;
             other condition known to interfere with interpretation of HbA1c measurement&#xD;
&#xD;
         13. History of neoplastic disease within 5 years prior to screening, except for adequately&#xD;
             treated basal cell, squamous cell skin cancer, or in situ cervical cancer&#xD;
&#xD;
         14. Any positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C&#xD;
             antibody, and human immunodeficiency virus (HIV) antibody&#xD;
&#xD;
         15. History of substance dependence, alcohol abuse, or excessive alcohol intake (defined&#xD;
             as an average weekly intake of &gt; 21 alcoholic drinks for men or &gt; 10 alcoholic drinks&#xD;
             for women) within 3 years prior to screening, and/or a positive screen for drugs of&#xD;
             abuse or alcohol at screening or on admission to the study unit. Subjects who use&#xD;
             tricyclic antidepressants or benzodiazepines for an established clinical indication&#xD;
             may be permitted to enter the study based upon the judgement of the investigator.&#xD;
&#xD;
         16. Involvement of any AstraZeneca, MedImmune, contract research organization, or study&#xD;
             site employee or their close relatives&#xD;
&#xD;
         17. History of acute or chronic pancreatitis or other diseases of the pancreas&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tim Heise, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Profil Institut für Stoffwechselforschung GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mainz</city>
        <zip>55116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Neu-Ulm</city>
        <zip>89231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Neuss</city>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=14682&amp;filename=D5670C00011_protocol_amendment_2_ct.pdf</url>
    <description>D5670C00011_protocol_amendment_2_ct</description>
  </link>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=14682&amp;filename=D5670C00011_Statistical_Analysis_Plan.pdf</url>
    <description>D5670C00011_Statistical_Analysis_Plan</description>
  </link>
  <link>
    <url>https://academic.oup.com/jcem/advance-article/doi/10.1210/clinem/dgz047/5586886</url>
    <description>A publication on the website: The Journal of Clinical Endocrinology &amp; Metabolism</description>
  </link>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <results_first_submitted>January 22, 2019</results_first_submitted>
  <results_first_submitted_qc>November 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 19, 2019</results_first_posted>
  <last_update_submitted>November 18, 2019</last_update_submitted>
  <last_update_submitted_qc>November 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>0382, T2DM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03244800/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03244800/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted across 5 sites in Germany between 04Sep2017 and 23Jan2018.</recruitment_details>
      <pre_assignment_details>A total of 120 participants consented to participate in the study. Of which 55 were screen failures; 65 participants were randomised (46 to MEDI0382 and 19 to placebo).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo Cohort 1</title>
          <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
        </group>
        <group group_id="P2">
          <title>MEDI0382 Cohort 1</title>
          <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
        </group>
        <group group_id="P3">
          <title>Placebo Cohort 2</title>
          <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
        </group>
        <group group_id="P4">
          <title>MEDI0382 Cohort 2</title>
          <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo Cohort 1</title>
          <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
        </group>
        <group group_id="B2">
          <title>MEDI0382 Cohort 1</title>
          <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
        </group>
        <group group_id="B3">
          <title>Placebo Cohort 2</title>
          <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
        </group>
        <group group_id="B4">
          <title>MEDI0382 Cohort 2</title>
          <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
        </group>
        <group group_id="B5">
          <title>TOTAL</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="20"/>
            <count group_id="B5" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.2" spread="5.6"/>
                    <measurement group_id="B2" value="58.7" spread="8.5"/>
                    <measurement group_id="B3" value="60.3" spread="9.5"/>
                    <measurement group_id="B4" value="61.9" spread="6.0"/>
                    <measurement group_id="B5" value="60.1" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaskan Native Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49</title>
        <description>The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported.</description>
        <time_frame>Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal</time_frame>
        <population>Pharmacodynamic (PD) population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49</title>
          <description>The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported.</description>
          <population>Pharmacodynamic (PD) population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.32" lower_limit="-0.74" upper_limit="13.38"/>
                    <measurement group_id="O2" value="-21.52" lower_limit="-26.51" upper_limit="-16.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cohort 1: Percent Change From Baseline in Body Weight to Day 50</title>
        <description>The percent change in body weight from baseline to Day 50 is reported.</description>
        <time_frame>Day 1 through Day 50</time_frame>
        <population>Intent-to-treat (ITT) population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Percent Change From Baseline in Body Weight to Day 50</title>
          <description>The percent change in body weight from baseline to Day 50 is reported.</description>
          <population>Intent-to-treat (ITT) population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" lower_limit="-1.88" upper_limit="1.46"/>
                    <measurement group_id="O2" value="-3.59" lower_limit="-4.77" upper_limit="-2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49</title>
        <description>The change from baseline in Glycated haemoglobin (HbA1c) to Day 49 is reported.</description>
        <time_frame>Baseline (Day -1) through Day 49</time_frame>
        <population>The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49</title>
          <description>The change from baseline in Glycated haemoglobin (HbA1c) to Day 49 is reported.</description>
          <population>The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
          <units>Percentage change</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" lower_limit="-0.27" upper_limit="0.14"/>
                    <measurement group_id="O2" value="-0.67" lower_limit="-0.82" upper_limit="-0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49</title>
        <description>The changes in the fasting plasma glucose level during the study period from baseline to Day 49 is reported.</description>
        <time_frame>Baseline (Day -1) through Day 49</time_frame>
        <population>The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49</title>
          <description>The changes in the fasting plasma glucose level during the study period from baseline to Day 49 is reported.</description>
          <population>The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.31" lower_limit="-12.74" upper_limit="8.13"/>
                    <measurement group_id="O2" value="-35.37" lower_limit="-42.75" upper_limit="-27.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Change From Baseline in Body Weight to Day 50</title>
        <description>The changes in the body weight during the study period from baseline to Day 50 is reported.</description>
        <time_frame>Day 1 through Day 50</time_frame>
        <population>The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Change From Baseline in Body Weight to Day 50</title>
          <description>The changes in the body weight during the study period from baseline to Day 50 is reported.</description>
          <population>The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
          <units>Kilogram</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" lower_limit="-1.45" upper_limit="1.28"/>
                    <measurement group_id="O2" value="-3.41" lower_limit="-4.37" upper_limit="-2.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50</title>
        <description>Participants achieving greater than or equal to 5% body weight loss from baseline to Day 50 is reported.</description>
        <time_frame>Day 1 through Day 50</time_frame>
        <population>The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50</title>
          <description>Participants achieving greater than or equal to 5% body weight loss from baseline to Day 50 is reported.</description>
          <population>The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.040</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>10.76</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.61</ci_lower_limit>
            <ci_upper_limit>72.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7</title>
        <description>The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) evaluation to Day 7 is reported.</description>
        <time_frame>Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal</time_frame>
        <population>The PD population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation. The number of participants analyzed at the specified time point for this outcome measure are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7</title>
          <description>The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) evaluation to Day 7 is reported.</description>
          <population>The PD population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation. The number of participants analyzed at the specified time point for this outcome measure are reported.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="11.70"/>
                    <measurement group_id="O2" value="-27.17" spread="9.83"/>
                    <measurement group_id="O3" value="1.77" spread="23.43"/>
                    <measurement group_id="O4" value="-31.80" spread="7.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first doses of study drug through 7 to 14 days after the last dose of study drug (approximately 64 days).</description>
        <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
        <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first doses of study drug through 7 to 14 days after the last dose of study drug (approximately 64 days).</description>
          <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TESAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs</title>
        <description>Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, heart rate, body temperature, and respiration rate.</description>
        <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
        <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs</title>
          <description>Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, heart rate, body temperature, and respiration rate.</description>
          <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs</title>
        <description>Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.</description>
        <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
        <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs</title>
          <description>Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.</description>
          <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs</title>
        <description>An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.</description>
        <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
        <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs</title>
          <description>An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.</description>
          <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Thrombocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema</title>
        <description>The injection site reactions observed during study visits were reported. Injection site reactions included (but are not limited to) local erythema, pain, tenderness, induration, swelling, pruritus, ulceration, and pigmentation.</description>
        <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
        <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema</title>
          <description>The injection site reactions observed during study visits were reported. Injection site reactions included (but are not limited to) local erythema, pain, tenderness, induration, swelling, pruritus, ulceration, and pigmentation.</description>
          <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382</title>
        <description>The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.</description>
        <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
        <population>Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382</title>
          <description>The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.</description>
          <population>Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226.31" lower_limit="103.95" upper_limit="488.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="248.83" lower_limit="86.57" upper_limit="558.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382</title>
        <description>The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.</description>
        <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382</title>
          <description>The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.67" lower_limit="34.05" upper_limit="47.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.51" lower_limit="8.99" upper_limit="69.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.75" lower_limit="26.38" upper_limit="65.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382</title>
        <description>The maximum observed concentration of MEDI0382 is reported.</description>
        <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382</title>
          <description>The maximum observed concentration of MEDI0382 is reported.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.24" lower_limit="4.89" upper_limit="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8" lower_limit="5.76" upper_limit="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382</title>
        <description>The maximum observed concentration of MEDI0382 is reported.</description>
        <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382</title>
          <description>The maximum observed concentration of MEDI0382 is reported.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="1.09" upper_limit="3.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.53" lower_limit="0.85" upper_limit="4.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.65" lower_limit="1.50" upper_limit="3.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382</title>
        <description>The time to reach the maximum observed concentration of MEDI0382 is reported.</description>
        <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382</title>
          <description>The time to reach the maximum observed concentration of MEDI0382 is reported.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="4" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382</title>
        <description>The time to reach the maximum observed concentration of MEDI0382 is reported.</description>
        <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382</title>
          <description>The time to reach the maximum observed concentration of MEDI0382 is reported.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="4" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="0" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="4" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Terminal Half Life (t1/2) of MEDI0382</title>
        <description>The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.</description>
        <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Terminal Half Life (t1/2) of MEDI0382</title>
          <description>The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>Hours</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.67" lower_limit="9.67" upper_limit="9.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="7.7" upper_limit="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Terminal Half Life (t1/2) of MEDI0382</title>
        <description>The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.</description>
        <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Terminal Half Life (t1/2) of MEDI0382</title>
          <description>The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>Hours</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" lower_limit="8.9" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="8.6" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" lower_limit="8.7" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Accumulation Ratio (Racc) of MEDI0382</title>
        <description>The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 22 and Day 49. Racc was calculated using the formula, Racc of Day 49 = AUCt of Day 49/AUCt of Day 22.</description>
        <time_frame>Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Accumulation Ratio (Racc) of MEDI0382</title>
          <description>The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 22 and Day 49. Racc was calculated using the formula, Racc of Day 49 = AUCt of Day 49/AUCt of Day 22.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.46" lower_limit="1.13" upper_limit="2.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Accumulation Ratio of MEDI0382</title>
        <description>The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 1, Day 7 and Day 14. Racc was calculated using the formulas: Racc of Day 7 = AUCt of Day 7/AUCt of Day 1; Racc of Day 14 = AUCt of Day 14/AUCt of Day 1.</description>
        <time_frame>Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Accumulation Ratio of MEDI0382</title>
          <description>The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 1, Day 7 and Day 14. Racc was calculated using the formulas: Racc of Day 7 = AUCt of Day 7/AUCt of Day 1; Racc of Day 14 = AUCt of Day 14/AUCt of Day 1.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" lower_limit="1.2" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.46" lower_limit="1.2" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382</title>
        <description>Trough plasma concentration is the measured concentration from the plasma concentration-time data at the end of a dosing interval at steady state.</description>
        <time_frame>Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382</title>
          <description>Trough plasma concentration is the measured concentration from the plasma concentration-time data at the end of a dosing interval at steady state.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.566" lower_limit="0.50" upper_limit="9.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.762" lower_limit="1.53" upper_limit="11.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382</title>
        <description>Trough plasma concentration is the measured concentration from the plasma concentration time data at the end of a dosing interval at steady state.</description>
        <time_frame>Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14</time_frame>
        <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382</title>
          <description>Trough plasma concentration is the measured concentration from the plasma concentration time data at the end of a dosing interval at steady state.</description>
          <population>The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.147" lower_limit="0.79" upper_limit="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.147" lower_limit="0.69" upper_limit="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382</title>
        <description>Participants with positive serum antibodies to MEDI0382 are reported.</description>
        <time_frame>Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])</time_frame>
        <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 Cohort 1</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 Cohort 2</title>
            <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382</title>
          <description>Participants with positive serum antibodies to MEDI0382 are reported.</description>
          <population>As-treated population included all participants who received any study drug and were analyzed according to the treatment they received. The &quot;Number Analyzed&quot; denotes the number of participants analyzed at the specified time point for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (ADA positive)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29 (ADA positive)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 50 (ADA positive)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up Visit 2 (ADA positive)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo Cohort 1</title>
          <description>Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.</description>
        </group>
        <group group_id="E2">
          <title>MEDI0382 Cohort 1</title>
          <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.</description>
        </group>
        <group group_id="E3">
          <title>Placebo Cohort 2</title>
          <description>Participants received placebo matching with MEDI0382 SC once daily for 49 days.</description>
        </group>
        <group group_id="E4">
          <title>MEDI0382 Cohort 2</title>
          <description>Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="8" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="11" subjects_affected="7" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Parotid gland enlargement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Regurgitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tongue discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="11" subjects_affected="4" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Induration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Medical device site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Medical device site swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasal herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="17" subjects_affected="13" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Loss of libido</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Victoria Parker</name_or_title>
      <organization>MedImmune Limited</organization>
      <phone>+44 747 1357152</phone>
      <email>information.center@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03244800
org study id: D5670C00011
nct id: NCT03244800
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety
      and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM).
      Approximately 63 subjects will be enrolled across two cohorts.
This is a randomised, double-blind, placebo-controlled study designed to evaluate the
      efficacy, safety, tolerability, and pharmacokinetics of different doses of MEDI0382
      administered as multiple SC doses to subjects with T2DM. Approximately 63 subjects will be
      enrolled across two cohorts.

      For cohort 1, sufficient subjects will be invited to participate in the study such that a
      maximum of 39 subjects will complete dosing. Subjects in cohort 1 will be randomised using a
      ratio of 2:1 to one of 2 treatment arms to receive either MEDI0382 or placebo. A maximum of
      26 will complete dosing in the active arm and 13 will complete dosing in the placebo arm.

      For cohort 2, sufficient subjects will be invited to participate in the study such that a
      maximum of 24 subjects will complete dosing. Subjects in cohort 2 will be randomised using a
      ratio of 3:1 to receive either MEDI0382 or placebo. A maximum of 18 will complete dosing in
      the active arm and 6 will complete dosing in the placebo arm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49
time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal
description: The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported.
measure: Cohort 1: Percent Change From Baseline in Body Weight to Day 50
time frame: Day 1 through Day 50
description: The percent change in body weight from baseline to Day 50 is reported.
measure: Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49
time frame: Baseline (Day -1) through Day 49
description: The change from baseline in Glycated haemoglobin (HbA1c) to Day 49 is reported.
measure: Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49
time frame: Baseline (Day -1) through Day 49
description: The changes in the fasting plasma glucose level during the study period from baseline to Day 49 is reported.
measure: Cohort 1: Change From Baseline in Body Weight to Day 50
time frame: Day 1 through Day 50
description: The changes in the body weight during the study period from baseline to Day 50 is reported.
measure: Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50
time frame: Day 1 through Day 50
description: Participants achieving greater than or equal to 5% body weight loss from baseline to Day 50 is reported.
measure: Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7
time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal
description: The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) evaluation to Day 7 is reported.
measure: Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
description: An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first doses of study drug through 7 to 14 days after the last dose of study drug (approximately 64 days).
measure: Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs
time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
description: Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, heart rate, body temperature, and respiration rate.
measure: Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs
time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
description: Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.
measure: Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
description: An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.
measure: Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema
time frame: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
description: The injection site reactions observed during study visits were reported. Injection site reactions included (but are not limited to) local erythema, pain, tenderness, induration, swelling, pruritus, ulceration, and pigmentation.
measure: Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
description: The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.
measure: Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
description: The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.
measure: Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382
time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
description: The maximum observed concentration of MEDI0382 is reported.
measure: Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382
time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
description: The maximum observed concentration of MEDI0382 is reported.
measure: Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
description: The time to reach the maximum observed concentration of MEDI0382 is reported.
measure: Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
description: The time to reach the maximum observed concentration of MEDI0382 is reported.
measure: Cohort 1: Terminal Half Life (t1/2) of MEDI0382
time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
description: The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.
measure: Cohort 2: Terminal Half Life (t1/2) of MEDI0382
time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
description: The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.
measure: Cohort 1: Accumulation Ratio (Racc) of MEDI0382
time frame: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
description: The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 22 and Day 49. Racc was calculated using the formula, Racc of Day 49 = AUCt of Day 49/AUCt of Day 22.
measure: Cohort 2: Accumulation Ratio of MEDI0382
time frame: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
description: The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 1, Day 7 and Day 14. Racc was calculated using the formulas: Racc of Day 7 = AUCt of Day 7/AUCt of Day 1; Racc of Day 14 = AUCt of Day 14/AUCt of Day 1.
measure: Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382
time frame: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
description: Trough plasma concentration is the measured concentration from the plasma concentration-time data at the end of a dosing interval at steady state.
measure: Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382
time frame: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
description: Trough plasma concentration is the measured concentration from the plasma concentration time data at the end of a dosing interval at steady state.
measure: Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382
time frame: Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])
description: Participants with positive serum antibodies to MEDI0382 are reported.
arm group label: Placebo Cohort 1
arm group type: Placebo Comparator
description: Participants will receive placebo matching with MEDI0382 subcutaneously once daily for 49 days.
arm group label: MEDI0382 Cohort 1
arm group type: Experimental
description: Participants will receive subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days
arm group label: PLacebo Cohort 2
arm group type: Placebo Comparator
description: Participants will receive placebo matching with MEDI0382 subcutaneously once daily for 49 days.
arm group label: MEDI0382 Cohort 2
arm group type: Experimental
description: Participants will receive subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
intervention type: Drug
intervention name: MEDI0382
description: MEDI0382 will be administered subcutaneously once daily for 49 days.
arm group label: MEDI0382 Cohort 1
arm group label: MEDI0382 Cohort 2
intervention type: Drug
intervention name: Placebo
description: Placebo will be administered subcutaneously once daily for 49 days.
arm group label: PLacebo Cohort 2
arm group label: Placebo Cohort 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Tim Heise, MD
role: Principal Investigator
affiliation: Profil Institut für Stoffwechselforschung GmbH
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14682&filename=D5670C00011_protocol_amendment_2_ct.pdf
description: D5670C00011_protocol_amendment_2_ct
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14682&filename=D5670C00011_Statistical_Analysis_Plan.pdf
description: D5670C00011_Statistical_Analysis_Plan
url: https://academic.oup.com/jcem/advance-article/doi/10.1210/clinem/dgz047/5586886
description: A publication on the website: The Journal of Clinical Endocrinology & Metabolism
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Overweight
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 