<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/NCT04408586</url>
  </required_header>
  <id_info>
    <org_study_id>19-011697</org_study_id>
    <nct_id>NCT04408586</nct_id>
  </id_info>
  <brief_title>Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker</brief_title>
  <official_title>Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers are assessing the effects of weight loss medication vs a placebo among&#xD;
      participants provided with a wearable activity tracker, digital wellness devices and&#xD;
      lifestyle recommendations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Actual">October 11, 2022</completion_date>
  <primary_completion_date type="Actual">June 13, 2022</primary_completion_date>
  <phase>Phase 4</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>Body Weight Change</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>Change in weight calculated in kilograms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Weight Change</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Change in weight calculated in kilograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Step Count</measure>
    <time_frame>baseline,12 months</time_frame>
    <description>The change in the number of steps per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Calories</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>The change in calories burned per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Sessions</measure>
    <time_frame>12 months</time_frame>
    <description>The number of exercise sessions per week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tracker Usage</measure>
    <time_frame>12 months</time_frame>
    <description>The amount of time in minutes the tracker was used per week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 Physical Score (Health-related Quality Quality of Life)</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Quality of life SF12 physical score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 Mental Score (Health-related Quality Quality of Life)</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Quality of life SF12 mental score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Phentermine - Topiramate Extended Release group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phentermine-Topiramate Extended Release</intervention_name>
    <description>Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily</description>
    <arm_group_label>Phentermine - Topiramate Extended Release group</arm_group_label>
    <other_name>Qsymia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo looks exactly like the study drug, but it contains no active ingredient</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online support system</intervention_name>
    <description>VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
    <arm_group_label>Phentermine - Topiramate Extended Release group</arm_group_label>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Adults with obesity (BMI &gt;30Kg/m2); these will be otherwise healthy individuals with&#xD;
             no unstable psychiatric disease and controlled comorbidities or other diseases.&#xD;
&#xD;
          -  Age: 18-75 years.&#xD;
&#xD;
          -  Gender: Men or women. Women of childbearing potential will have negative pregnancy&#xD;
             tests within 48 hours of enrollment.&#xD;
&#xD;
          -  Women of childbearing potential must agree to use a method of effective contraception&#xD;
             during study participation.&#xD;
&#xD;
          -  Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to&#xD;
             download the VitalCare (VitalTech Affiliates LLC) application from the Apple App&#xD;
             Store.&#xD;
&#xD;
          -  Able to provide written informed consent prior to any study procedures, and be willing&#xD;
             and able to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  History of Abdominal bariatric surgery&#xD;
&#xD;
          -  Weight is greater than 450 lbs (204 kg)&#xD;
&#xD;
          -  Recent use (within the last three months) of any antiobesity medication&#xD;
&#xD;
          -  Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months)&#xD;
&#xD;
          -  Positive history of chronic gastrointestinal diseases, or systemic disease that could&#xD;
             affect gastrointestinal motility, or use of medications that may alter&#xD;
             gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6&#xD;
             months.&#xD;
&#xD;
          -  Significant untreated psychiatric dysfunction based upon screening with the Hospital&#xD;
             Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight&#xD;
             Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by&#xD;
             an anxiety or depression score &gt;11 or difficulties with substance or eating disorders,&#xD;
             the participant will be excluded and given a referral letter to his/her primary care&#xD;
             doctor for further appraisal and follow-up.&#xD;
&#xD;
          -  Hypersensitivity or contraindication to the study medication.&#xD;
&#xD;
          -  Participant unable or unwilling to follow protocol including use of the wearable&#xD;
             activity tracker, digital wellness devices, VitalCare application, or unwilling to&#xD;
             sign consent.&#xD;
&#xD;
          -  Principal Investigator discretion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andres Acosta, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <results_first_submitted>May 23, 2023</results_first_submitted>
  <results_first_submitted_qc>June 15, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 22, 2023</results_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Andres J. Acosta, M.D., Ph.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Topiramate</mesh_term>
    <mesh_term>Phentermine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT04408586/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Phentermine - Topiramate Extended Release Group</title>
          <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Group</title>
          <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Phentermine - Topiramate Extended Release Group</title>
          <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Group</title>
          <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</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="42"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="80"/>
          </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="43.4" spread="10.9"/>
                    <measurement group_id="B2" value="40.8" spread="10.2"/>
                    <measurement group_id="B3" value="42" spread="10.4"/>
                  </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="36"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="0"/>
                    <measurement group_id="B3" 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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Body Weight Change</title>
        <description>Change in weight calculated in kilograms.</description>
        <time_frame>baseline, 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phentermine - Topiramate Extended Release Group</title>
            <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight Change</title>
          <description>Change in weight calculated in kilograms.</description>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.80" lower_limit="-13.72" upper_limit="-7.92"/>
                    <measurement group_id="O2" value="-4.04" lower_limit="-7.05" upper_limit="-1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Weight Change</title>
        <description>Change in weight calculated in kilograms.</description>
        <time_frame>baseline, 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phentermine - Topiramate Extended Release Group</title>
            <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight Change</title>
          <description>Change in weight calculated in kilograms.</description>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.32" lower_limit="-18.65" upper_limit="-12.00"/>
                    <measurement group_id="O2" value="-5.85" lower_limit="-9.40" upper_limit="-2.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Step Count</title>
        <description>The change in the number of steps per day</description>
        <time_frame>baseline,12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phentermine - Topiramate Extended Release Group</title>
            <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Step Count</title>
          <description>The change in the number of steps per day</description>
          <units>steps per day</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1214" lower_limit="-192" upper_limit="2620"/>
                    <measurement group_id="O2" value="2316" lower_limit="807" upper_limit="3824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Calories</title>
        <description>The change in calories burned per day</description>
        <time_frame>baseline, 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phentermine - Topiramate Extended Release Group</title>
            <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Calories</title>
          <description>The change in calories burned per day</description>
          <units>kcal per day</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-193" lower_limit="-356" upper_limit="-30"/>
                    <measurement group_id="O2" value="60" lower_limit="-127" upper_limit="247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exercise Sessions</title>
        <description>The number of exercise sessions per week</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phentermine - Topiramate Extended Release Group</title>
            <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
        </group_list>
        <measure>
          <title>Exercise Sessions</title>
          <description>The number of exercise sessions per week</description>
          <units>sessions per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1"/>
                    <measurement group_id="O2" value="2.1" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tracker Usage</title>
        <description>The amount of time in minutes the tracker was used per week</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phentermine - Topiramate Extended Release Group</title>
            <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
        </group_list>
        <measure>
          <title>Tracker Usage</title>
          <description>The amount of time in minutes the tracker was used per week</description>
          <units>minutes/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" spread="15"/>
                    <measurement group_id="O2" value="94" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 Physical Score (Health-related Quality Quality of Life)</title>
        <description>Quality of life SF12 physical score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome</description>
        <time_frame>baseline, 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phentermine - Topiramate Extended Release Group</title>
            <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 Physical Score (Health-related Quality Quality of Life)</title>
          <description>Quality of life SF12 physical score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.99" lower_limit="-0.34" upper_limit="4.32"/>
                    <measurement group_id="O2" value="0.57" lower_limit="-1.76" upper_limit="2.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 Mental Score (Health-related Quality Quality of Life)</title>
        <description>Quality of life SF12 mental score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.</description>
        <time_frame>baseline, 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phentermine - Topiramate Extended Release Group</title>
            <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 Mental Score (Health-related Quality Quality of Life)</title>
          <description>Quality of life SF12 mental score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" lower_limit="-1.66" upper_limit="2.50"/>
                    <measurement group_id="O2" value="-1.48" lower_limit="-3.56" upper_limit="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from baseline to end of study, approximately 12 months for each subject</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Phentermine - Topiramate Extended Release Group</title>
          <description>Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Group</title>
          <description>Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient&#xD;
Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.</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="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="11" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Andres J. Acosta, M.D., Ph.D.</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-266-6931</phone>
      <email>Acosta.Andres@mayo.edu</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/NCT04408586
org study id: 19-011697
nct id: NCT04408586
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Researchers are assessing the effects of weight loss medication vs a placebo among
      participants provided with a wearable activity tracker, digital wellness devices and
      lifestyle recommendations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Body Weight Change
time frame: baseline, 3 months
description: Change in weight calculated in kilograms.
measure: Body Weight Change
time frame: baseline, 12 months
description: Change in weight calculated in kilograms.
measure: Change in Step Count
time frame: baseline,12 months
description: The change in the number of steps per day
measure: Change in Calories
time frame: baseline, 12 months
description: The change in calories burned per day
measure: Exercise Sessions
time frame: 12 months
description: The number of exercise sessions per week
measure: Tracker Usage
time frame: 12 months
description: The amount of time in minutes the tracker was used per week
measure: Change in SF-12 Physical Score (Health-related Quality Quality of Life)
time frame: baseline, 12 months
description: Quality of life SF12 physical score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome
measure: Change in SF-12 Mental Score (Health-related Quality Quality of Life)
time frame: baseline, 12 months
description: Quality of life SF12 mental score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.
arm group label: Phentermine - Topiramate Extended Release group
arm group type: Active Comparator
arm group label: Placebo Group
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Phentermine-Topiramate Extended Release
description: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
arm group label: Phentermine - Topiramate Extended Release group
other name: Qsymia
intervention type: Drug
intervention name: Placebo
description: Placebo looks exactly like the study drug, but it contains no active ingredient
arm group label: Placebo Group
intervention type: Other
intervention name: Online support system
description: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.
arm group label: Phentermine - Topiramate Extended Release group
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andres Acosta, MD, PhD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Andres J. Acosta, M.D., Ph.D.
investigator title: Principal Investigator
mesh term: Obesity
mesh term: Topiramate
mesh term: Phentermine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 