<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/NCT03254368</url>
  </required_header>
  <id_info>
    <org_study_id>ZAF-1061-201</org_study_id>
    <secondary_id>U1111-1196-7527</secondary_id>
    <nct_id>NCT03254368</nct_id>
  </id_info>
  <brief_title>Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes</brief_title>
  <official_title>Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of ZGN-1061 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Glycemic Control, Safety, and Tolerability Over 12 Weeks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zafgen, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zafgen, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061&#xD;
      in participants with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive&#xD;
      0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will&#xD;
      receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">February 22, 2019</completion_date>
  <primary_completion_date type="Actual">November 12, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability as assessed by incidence of adverse events</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-peptide</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in proinsulin</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glucagon</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects achieving HbA1c &lt;7% and ≤6.5%</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in beta-cell function</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin sensitivity</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist and hip circumference</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biomarkers relevant to obesity and/or type 2 diabetes</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient reported outcomes measures</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">188</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>0.05 mg ZGN-1061 (A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.05 mg ZGN-1061 subcutaneous injection once every 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.3 mg ZGN-1061 (B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.3 mg ZGN-1061 subcutaneous injection once every 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.9 mg ZGN-1061 (C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.9 mg ZGN-1061 subcutaneous injection once every 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1.8 mg ZGN-1061 (CC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.8 mg ZGN-1061 subcutaneous injection once every 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (D)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo subcutaneous injection once every 3 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZGN-1061</intervention_name>
    <description>ZGN-1061 is a methionine aminopeptidase 2 inhibitor</description>
    <arm_group_label>0.05 mg ZGN-1061 (A)</arm_group_label>
    <arm_group_label>0.3 mg ZGN-1061 (B)</arm_group_label>
    <arm_group_label>0.9 mg ZGN-1061 (C)</arm_group_label>
    <arm_group_label>1.8 mg ZGN-1061 (CC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo has the same excipients and appearance as ZGN-1061</description>
    <arm_group_label>Placebo (D)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must meet the following criteria to participate in this study:&#xD;
&#xD;
          -  Be between the ages of 18 and 70 years, inclusive.&#xD;
&#xD;
          -  Overweight or obese with a body mass index of at least 27 kg/m².&#xD;
&#xD;
          -  Have type 2 diabetes with HbA1c between 7% and 11%.&#xD;
&#xD;
          -  For subjects taking approved antidiabetes medications, the doses must be stable as&#xD;
             determined by the study doctor.&#xD;
&#xD;
          -  For subjects who have had weight-loss surgery (example: gastric banding), the&#xD;
             procedure must have occurred at least 1 year ago, and be verified with documentation&#xD;
             or by a health professional associated with the surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects cannot participate in this research study if they meet any of the following:&#xD;
&#xD;
          -  Have taken another study drug or study device within the past 6 months.&#xD;
&#xD;
          -  Are taking certain prescribed medications including narcotics or opiates.&#xD;
&#xD;
          -  Consistent recent use of insulin.&#xD;
&#xD;
          -  Have had recent major surgery or prolonged bed rest, or planning or likely to undergo&#xD;
             any surgery during the research study.&#xD;
&#xD;
          -  Have a history of bleeding disorders or risk factors for excessive blood clotting.&#xD;
&#xD;
          -  Have difficulty giving blood.&#xD;
&#xD;
          -  Have a history of drug and/or alcohol abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Kim, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Zafgen, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Coffs Harbour GP SuperClinic</name>
      <address>
        <city>Coffs Harbour</city>
        <state>New South Wales</state>
        <zip>2450</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Health</name>
      <address>
        <city>Coffs Harbour</city>
        <state>New South Wales</state>
        <zip>2450</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Aim Centre</name>
      <address>
        <city>Merewether</city>
        <state>New South Wales</state>
        <zip>2291</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Boden Institute</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holdsworth House Medical Practice</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pendlebury Research</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2289</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Q-Pharm</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Griffith University, Gold Coast Campus</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4222</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Adelaide Diabetes &amp; Endocrine Services</name>
      <address>
        <city>Daw Park</city>
        <state>South Australia</state>
        <zip>5041</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Clinical Research Unit (ECRU)</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barwon Health</name>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3218</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Clinical Trials</name>
      <address>
        <city>Auckland</city>
        <zip>1021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Middlemore Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>2025</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Diabetes Centre</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Clinical Trials</name>
      <address>
        <city>Christchurch</city>
        <zip>8024</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lipid and Diabetes Research Group</name>
      <address>
        <city>Christchurch</city>
        <zip>8140</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials New Zealand Ltd</name>
      <address>
        <city>Hamilton</city>
        <zip>3206</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P3 Research Hawkes Bay</name>
      <address>
        <city>Hastings</city>
        <zip>4130</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P3 Research Wellington</name>
      <address>
        <city>Newtown</city>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeland Clinical Trials</name>
      <address>
        <city>Rotorua</city>
        <zip>3010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P3 Research Tauranga</name>
      <address>
        <city>Tauranga</city>
        <zip>3110</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Wellington</city>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>May 22, 2019</last_update_submitted>
  <last_update_submitted_qc>May 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Methionine Aminopeptidase 2 Inhibitor</keyword>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>Blood Glucose</keyword>
  <keyword>Overweight</keyword>
  <keyword>Obesity</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>ZGN-1061</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03254368
org study id: ZAF-1061-201
secondary id: U1111-1196-7527
nct id: NCT03254368
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061
      in participants with type 2 diabetes.
Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive
      0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will
      receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in HbA1c
time frame: 12 weeks
measure: Safety and tolerability as assessed by incidence of adverse events
time frame: 12 weeks
measure: Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
time frame: 12 weeks
measure: Change in body weight
time frame: 12 weeks
measure: Change in fasting plasma glucose
time frame: 12 weeks
measure: Change in insulin
time frame: 12 weeks
measure: Change in C-peptide
time frame: 12 weeks
measure: Change in proinsulin
time frame: 12 weeks
measure: Change in glucagon
time frame: 12 weeks
measure: Proportion of subjects achieving HbA1c <7% and ≤6.5%
time frame: 12 weeks
measure: Change in beta-cell function
time frame: 12 weeks
measure: Change in insulin sensitivity
time frame: 12 weeks
measure: Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects
time frame: 12 weeks
measure: Change in waist and hip circumference
time frame: 12 weeks
measure: Change in biomarkers relevant to obesity and/or type 2 diabetes
time frame: 12 weeks
measure: Change in patient reported outcomes measures
time frame: 12 weeks
arm group label: 0.05 mg ZGN-1061 (A)
arm group type: Experimental
description: 0.05 mg ZGN-1061 subcutaneous injection once every 3 days
arm group label: 0.3 mg ZGN-1061 (B)
arm group type: Experimental
description: 0.3 mg ZGN-1061 subcutaneous injection once every 3 days
arm group label: 0.9 mg ZGN-1061 (C)
arm group type: Experimental
description: 0.9 mg ZGN-1061 subcutaneous injection once every 3 days
arm group label: 1.8 mg ZGN-1061 (CC)
arm group type: Experimental
description: 1.8 mg ZGN-1061 subcutaneous injection once every 3 days
arm group label: Placebo (D)
arm group type: Placebo Comparator
description: Placebo subcutaneous injection once every 3 days
intervention type: Drug
intervention name: ZGN-1061
description: ZGN-1061 is a methionine aminopeptidase 2 inhibitor
arm group label: 0.05 mg ZGN-1061 (A)
arm group label: 0.3 mg ZGN-1061 (B)
arm group label: 0.9 mg ZGN-1061 (C)
arm group label: 1.8 mg ZGN-1061 (CC)
intervention type: Drug
intervention name: Placebo
description: Placebo has the same excipients and appearance as ZGN-1061
arm group label: Placebo (D)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dennis Kim, MD
role: Study Chair
affiliation: Zafgen, Inc.
facility: 
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country: Australia
country: New Zealand
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Overweight
mesh term: ZGN-1061
sharing ipd: No