<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/NCT02229214</url>
  </required_header>
  <id_info>
    <org_study_id>OB-404</org_study_id>
    <nct_id>NCT02229214</nct_id>
  </id_info>
  <brief_title>Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects</brief_title>
  <official_title>A Phase IV, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of VI-0521 on the Glomerular Filtration Rate of Healthy Overweight or Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VIVUS LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VIVUS LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is measure the effect of VI-0521 on kidney function.&#xD;
      Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of&#xD;
      study treatment, and after an additional 4 weeks of off-treatment recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, single-site study in healthy&#xD;
      overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and&#xD;
      topiramate [PHEN/TPM] extended-release capsule) will be administered daily as follows:&#xD;
&#xD;
        -  Days 1-3: PHEN/TPM 3.75 mg /23 mg&#xD;
&#xD;
        -  Days 4-6: PHEN/TPM 7.5 mg /46 mg&#xD;
&#xD;
        -  Days 7-9: PHEN/TPM 11.25 mg /69 mg&#xD;
&#xD;
        -  Days 10-28: PHEN/TPM 15 mg /92 mg&#xD;
&#xD;
      A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be&#xD;
      administered intravenously on three separate occasions.&#xD;
&#xD;
      The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom&#xD;
      will have overnight stays on 3 separate occasions.&#xD;
&#xD;
      Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4&#xD;
      weeks post treatment follow up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment</measure>
    <time_frame>Baseline, end of treatment</time_frame>
    <description>Method that uses iohexol clearance and body surface area to measure kidney function.&#xD;
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment</measure>
    <time_frame>Baseline, 28 days after end of treatment</time_frame>
    <description>Method that uses iohexol clearance and body surface area to measure kidney function.&#xD;
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Creatinine From Baseline to End of Treatment</measure>
    <time_frame>Baseline, end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Creatinine From Baseline to 28 Days After End of Treatment</measure>
    <time_frame>Baseline, 28 days after end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cystatin C From Baseline to End of Treatment</measure>
    <time_frame>Baseline, end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cystatin C From Baseline to 28 Days After End of Treatment</measure>
    <time_frame>Baseline, 28 days after end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With a Decrease of &gt;/= 15% in Iohexol Clearance From Baseline to End of Treatment</measure>
    <time_frame>Baseline, end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With a Decrease of &gt;/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment</measure>
    <time_frame>Baseline, 28 days after end of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>VI-0521 (Qsymia)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Days 1-28: Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qsymia</intervention_name>
    <arm_group_label>VI-0521 (Qsymia)</arm_group_label>
    <other_name>VI-0521</other_name>
    <other_name>Phentermine and Topiramate ER (Extended Release)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Sugar pill</arm_group_label>
    <other_name>Sugar Pill</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 18 - 65 years of age, medically healthy with no clinically significant&#xD;
             screening abnormalities&#xD;
&#xD;
          -  BMI of ≥27 to ≤45 kg/m2&#xD;
&#xD;
          -  No use of any medication (prescription, over the counter (OTC) or herbal preparations)&#xD;
             with the exception of contraception for the entirety of the study&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or hypersensitivity to radio contrast media, iodine or shellfish&#xD;
&#xD;
          -  Plans to significantly alter their diet through fasting, very low caloric intake,&#xD;
             elimination of certain foods (gluten, milk, meat, etc.) or similar&#xD;
&#xD;
          -  Plans to undertake a significant change to physical exercise levels (i.e., initiate&#xD;
             training for a marathon) during the study period&#xD;
&#xD;
          -  Consumption of a high protein diet or protein/body building meal supplementation&#xD;
             and/or replacement. The use of any product containing creatine is strictly prohibited&#xD;
&#xD;
          -  History of glaucoma or increased intraocular pressure&#xD;
&#xD;
          -  History of bipolar disorder or psychosis, history of psychiatric hospitalization,&#xD;
             greater than one lifetime episode of major depression, current depression of moderate&#xD;
             or greater severity, presence or history of suicidal behavior or ideation with some&#xD;
             intent to act on it&#xD;
&#xD;
          -  Cholelithiasis (gallstones) within the past 6 months&#xD;
&#xD;
          -  History of nephrolithiasis (kidney stones)&#xD;
&#xD;
          -  Evidence of any clinically significant renal, pulmonary, hepatic, psychiatric or other&#xD;
             condition by history, physical examination or laboratory studies that, in the opinion&#xD;
             of the investigator, would contraindicate the administration of study medications,&#xD;
             affect compliance, interfere with study evaluations or confound the interpretation of&#xD;
             study results as determined by the investigator&#xD;
&#xD;
          -  Current use of any tobacco products including cigarettes, cigars, pipes, and chewing&#xD;
             tobacco, or nicotine replacement products (e.g., patch, gum, lozenge, etc.), or&#xD;
             chronic use within the previous three months prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Galloway, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <results_first_submitted>November 17, 2015</results_first_submitted>
  <results_first_submitted_qc>January 12, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 9, 2016</results_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal function</keyword>
  <keyword>Glomerular Filtration Rate</keyword>
  <keyword>Kidney function</keyword>
  <keyword>Qsymia</keyword>
  <keyword>Iohexol</keyword>
  <keyword>Serum Creatinine</keyword>
  <keyword>Creatinine clearance</keyword>
  <keyword>Renal Clearance</keyword>
  <keyword>VI-0521</keyword>
  <keyword>Healthy volunteers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>VI-0521 (Qsymia)</title>
          <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Days 1-28: Placebo&#xD;
Sugar Pill</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>VI-0521 (Qsymia)</title>
          <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Days 1-28: Placebo&#xD;
Placebo (sugar pill)</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="41"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="51"/>
          </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="38.4" spread="11.07"/>
                    <measurement group_id="B2" value="37.6" spread="9.80"/>
                    <measurement group_id="B3" value="38.2" spread="10.74"/>
                  </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="27"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="35"/>
                  </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>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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="38"/>
                  </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="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </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="41"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>Kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.2" spread="4.72"/>
                    <measurement group_id="B2" value="31.3" spread="2.81"/>
                    <measurement group_id="B3" value="32.8" spread="4.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>iGFR</title>
          <units>mL/min/1.73m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95.1" spread="14.05"/>
                    <measurement group_id="B2" value="87.3" spread="9.06"/>
                    <measurement group_id="B3" value="93.6" spread="13.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment</title>
        <description>Method that uses iohexol clearance and body surface area to measure kidney function.&#xD;
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.</description>
        <time_frame>Baseline, end of treatment</time_frame>
        <population>The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment iGFR measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>VI-0521 (Qsymia)</title>
            <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Days 1-28: Placebo&#xD;
Sugar Pill</description>
          </group>
        </group_list>
        <measure>
          <title>Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment</title>
          <description>Method that uses iohexol clearance and body surface area to measure kidney function.&#xD;
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.</description>
          <population>The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment iGFR measurements.</population>
          <units>mL/min/1.73 m^2</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.92" spread="1.28"/>
                    <measurement group_id="O2" value="1.08" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Serum Creatinine From Baseline to End of Treatment</title>
        <time_frame>Baseline, end of treatment</time_frame>
        <population>The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment serum creatininine measurements</population>
        <group_list>
          <group group_id="O1">
            <title>VI-0521 (Qsymia)</title>
            <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
          </group>
          <group group_id="O2">
            <title>Sugar Pill</title>
            <description>Days 1-28: Placebo&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Serum Creatinine From Baseline to End of Treatment</title>
          <population>The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment serum creatininine measurements</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.01"/>
                    <measurement group_id="O2" value="0.03" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Serum Creatinine From Baseline to 28 Days After End of Treatment</title>
        <time_frame>Baseline, 28 days after end of treatment</time_frame>
        <population>The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment serum creatinine measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>VI-0521 (Qsymia)</title>
            <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
          </group>
          <group group_id="O2">
            <title>Sugar Pill</title>
            <description>Days 1-28: Placebo&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Serum Creatinine From Baseline to 28 Days After End of Treatment</title>
          <population>The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment serum creatinine measurements.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.01"/>
                    <measurement group_id="O2" value="0.03" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cystatin C From Baseline to End of Treatment</title>
        <time_frame>Baseline, end of treatment</time_frame>
        <population>The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment cystatin C measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>VI-0521 (Qsymia)</title>
            <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Days 1-28: Placebo&#xD;
Sugar Pill</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cystatin C From Baseline to End of Treatment</title>
          <population>The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment cystatin C measurements.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.01"/>
                    <measurement group_id="O2" value="0.03" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment</title>
        <description>Method that uses iohexol clearance and body surface area to measure kidney function.&#xD;
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR</description>
        <time_frame>Baseline, 28 days after end of treatment</time_frame>
        <population>The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after treatment iGFR measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>VI-0521 (Qsymia)</title>
            <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
          </group>
          <group group_id="O2">
            <title>Sugar Pill</title>
            <description>Days 1-28: Placebo&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment</title>
          <description>Method that uses iohexol clearance and body surface area to measure kidney function.&#xD;
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR</description>
          <population>The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after treatment iGFR measurements.</population>
          <units>mL/min/1.73 m^2</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.75" spread="1.49"/>
                    <measurement group_id="O2" value="2.34" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cystatin C From Baseline to 28 Days After End of Treatment</title>
        <time_frame>Baseline, 28 days after end of treatment</time_frame>
        <population>The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment cystatin C measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>VI-0521 (Qsymia)</title>
            <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Days 1-28: Placebo&#xD;
Sugar Pill</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cystatin C From Baseline to 28 Days After End of Treatment</title>
          <population>The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment cystatin C measurements.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.01"/>
                    <measurement group_id="O2" value="0.02" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With a Decrease of &gt;/= 15% in Iohexol Clearance From Baseline to End of Treatment</title>
        <time_frame>Baseline, end of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VI-0521 (Qsymia)</title>
            <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Days 1-28: Placebo&#xD;
Placebo (sugar pill)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a Decrease of &gt;/= 15% in Iohexol Clearance From Baseline to End of Treatment</title>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.8"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With a Decrease of &gt;/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment</title>
        <time_frame>Baseline, 28 days after end of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VI-0521 (Qsymia)</title>
            <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Days 1-28: Placebo&#xD;
Placebo (sugar pill)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a Decrease of &gt;/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment</title>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>VI-0521 (Qsymia)</title>
          <description>Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)&#xD;
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)&#xD;
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)&#xD;
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)&#xD;
Qsymia</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Days 1-28: Placebo&#xD;
Sugar Pill</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <description>Subject was inside a boom trimming trees when the middle of the metal arm of the boom broke and resulted in subject falling.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ocular Hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Paraesthesia Oral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscle Spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysfunctional Uterine Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinus Congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Craig Peterson, Sr. Director, Clinical Research</name_or_title>
      <organization>VIVUS Inc.</organization>
      <phone>650-934-5200</phone>
      <email>ClinicalTrials@vivus.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/NCT02229214
org study id: OB-404
nct id: NCT02229214
lead sponsor: 
has dmc: No
The main purpose of this study is measure the effect of VI-0521 on kidney function.
      Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of
      study treatment, and after an additional 4 weeks of off-treatment recovery.
This is a randomized, double-blind, placebo-controlled, single-site study in healthy
      overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and
      topiramate [PHEN/TPM] extended-release capsule) will be administered daily as follows:

        -  Days 1-3: PHEN/TPM 3.75 mg /23 mg

        -  Days 4-6: PHEN/TPM 7.5 mg /46 mg

        -  Days 7-9: PHEN/TPM 11.25 mg /69 mg

        -  Days 10-28: PHEN/TPM 15 mg /92 mg

      A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be
      administered intravenously on three separate occasions.

      The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom
      will have overnight stays on 3 separate occasions.

      Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4
      weeks post treatment follow up).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment
time frame: Baseline, end of treatment
description: Method that uses iohexol clearance and body surface area to measure kidney function.
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.
measure: Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment
time frame: Baseline, 28 days after end of treatment
description: Method that uses iohexol clearance and body surface area to measure kidney function.
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR
measure: Change in Serum Creatinine From Baseline to End of Treatment
time frame: Baseline, end of treatment
measure: Change in Serum Creatinine From Baseline to 28 Days After End of Treatment
time frame: Baseline, 28 days after end of treatment
measure: Change in Cystatin C From Baseline to End of Treatment
time frame: Baseline, end of treatment
measure: Change in Cystatin C From Baseline to 28 Days After End of Treatment
time frame: Baseline, 28 days after end of treatment
measure: Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment
time frame: Baseline, end of treatment
measure: Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment
time frame: Baseline, 28 days after end of treatment
arm group label: VI-0521 (Qsymia)
arm group type: Experimental
description: Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
arm group label: Sugar pill
arm group type: Placebo Comparator
description: Days 1-28: Placebo
intervention type: Drug
intervention name: Qsymia
arm group label: VI-0521 (Qsymia)
other name: VI-0521
other name: Phentermine and Topiramate ER (Extended Release)
intervention type: Drug
intervention name: Placebo
arm group label: Sugar pill
other name: Sugar Pill
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chris Galloway, MD
role: Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
mesh term: Topiramate
mesh term: Phentermine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 