<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/NCT01681069</url>
  </required_header>
  <id_info>
    <org_study_id>INQ/009712</org_study_id>
    <nct_id>NCT01681069</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of IQP-VV-102 in Weight Management</brief_title>
  <official_title>Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-VV-102 in Reducing Body Weight in Overweight and Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InQpharm Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InQpharm Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the&#xD;
      subjects' body weight, body fat and safety parameters are monitored&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight at End of Study Compared to Baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in body weight at the end of study compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Circumference (in cm) at End of Study From Baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in waist circumference (in cm) at end of study from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Body Fat at End of Study From Baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured in kg using calibrated weighing scales</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>IQP-VV-102</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 tablets twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 tablets twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>IQP-VV-102</intervention_name>
    <arm_group_label>IQP-VV-102</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 60 years&#xD;
&#xD;
          -  25 kg/m2 ≤ BMI ≤ 35 kg/m2&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known sensitivity to sources of the active ingredients and excipients&#xD;
&#xD;
          -  Pregnancy or nursing&#xD;
&#xD;
          -  Inability to comply with study requirements, e.g. due to language difficulties&#xD;
&#xD;
          -  Participation in another study during the last 30 days of the screening visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara Grube, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Practice for General Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barbara Grube</name>
      <address>
        <city>Berlin</city>
        <zip>10709</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>September 1, 2015</results_first_submitted>
  <results_first_submitted_qc>October 5, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 6, 2015</results_first_posted>
  <last_update_submitted>October 5, 2015</last_update_submitted>
  <last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IQP-VV-102</title>
          <description>2 tablets twice a day&#xD;
IQP-VV-102</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>2 tablets twice a day&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set (FAS)</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55">Valid Case Analysis Set (VAS)</participants>
                <participants group_id="P2" count="53">Valid Case Analysis Set (VAS)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>*Only 117 out of 118 subjects included in the intention-to-treat population as one subject was lost to follow-up after visit 3</population>
      <group_list>
        <group group_id="B1">
          <title>IQP-VV-102</title>
          <description>2 tablets twice a day&#xD;
IQP-VV-102</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>2 tablets twice a day&#xD;
Placebo</description>
        </group>
        <group group_id="B3">
          <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="57"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="117"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.6" spread="11.6"/>
                    <measurement group_id="B2" value="40.5" spread="11.9"/>
                    <measurement group_id="B3" value="42.0" spread="11.8"/>
                  </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="45"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.0" spread="10.6"/>
                    <measurement group_id="B2" value="84.9" spread="12.9"/>
                    <measurement group_id="B3" value="83.5" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Body Weight at End of Study Compared to Baseline</title>
        <description>Change in body weight at the end of study compared to baseline</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IQP-VV-102</title>
            <description>2 tablets twice a day&#xD;
IQP-VV-102</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>2 tablets twice a day&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight at End of Study Compared to Baseline</title>
          <description>Change in body weight at the end of study compared to baseline</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="2.30"/>
                    <measurement group_id="O2" value="0.83" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Waist Circumference (in cm) at End of Study From Baseline</title>
        <description>Difference in waist circumference (in cm) at end of study from baseline</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IQP-VV-102</title>
            <description>2 tablets twice a day&#xD;
IQP-VV-102</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>2 tablets twice a day&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Waist Circumference (in cm) at End of Study From Baseline</title>
          <description>Difference in waist circumference (in cm) at end of study from baseline</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.11" spread="2.09"/>
                    <measurement group_id="O2" value="0.81" spread="2.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Body Fat at End of Study From Baseline</title>
        <description>Measured in kg using calibrated weighing scales</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IQP-VV-102</title>
            <description>2 tablets twice a day&#xD;
IQP-VV-102</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>2 tablets twice a day&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Body Fat at End of Study From Baseline</title>
          <description>Measured in kg using calibrated weighing scales</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="3.42"/>
                    <measurement group_id="O2" value="0.56" spread="2.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <desc>All adverse effect reported were not deemed associated with the investigational product</desc>
      <group_list>
        <group group_id="E1">
          <title>IQP-VV-102</title>
          <description>2 tablets twice a day&#xD;
IQP-VV-102</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>2 tablets twice a day&#xD;
Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="5" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyrodism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomitting and diarhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Bruised left thigh</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory infections</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="60"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Christof Jänicke</name_or_title>
      <organization>Analyze &amp; Realize GmBH</organization>
      <phone>+49 30 40 00 83 23</phone>
      <email>cj@a-r.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/NCT01681069
org study id: INQ/009712
nct id: NCT01681069
lead sponsor: 
has dmc: No
Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the
      subjects' body weight, body fat and safety parameters are monitored
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Body Weight at End of Study Compared to Baseline
time frame: 12 weeks
description: Change in body weight at the end of study compared to baseline
measure: Change in Waist Circumference (in cm) at End of Study From Baseline
time frame: 12 weeks
description: Difference in waist circumference (in cm) at end of study from baseline
measure: Change in Mean Body Fat at End of Study From Baseline
time frame: 12 weeks
description: Measured in kg using calibrated weighing scales
arm group label: IQP-VV-102
arm group type: Active Comparator
description: 2 tablets twice a day
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 tablets twice a day
intervention type: Dietary Supplement
intervention name: IQP-VV-102
arm group label: IQP-VV-102
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara Grube, MD
role: Principal Investigator
affiliation: Practice for General Medicine
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Overweight
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 