<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/NCT03005717</url>
  </required_header>
  <id_info>
    <org_study_id>LIPO-202-CL-31</org_study_id>
    <nct_id>NCT03005717</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat</brief_title>
  <official_title>A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of LIPO-202 (Salmeterol Xinafoate for Injection) for the Reduction of Submental Subcutaneous Fat</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neothetics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neothetics, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to&#xD;
      evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on&#xD;
      submental bulging due to subcutaneous fat. Approximately 150 participants of either gender&#xD;
      who have a &quot;Moderate Bulge&quot; or &quot;Large Bulge&quot; in the submental fat (on Patient-Reported&#xD;
      Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS])&#xD;
      will be recruited for this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential subjects will present and complete the Screening Visit. All qualifying subjects&#xD;
      will be randomized to one of three treatment groups and treated with up to 30 subcutaneous&#xD;
      injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon&#xD;
      completion of treatment visits, subject will return to the clinic for a follow-up visit and&#xD;
      end of study visit, one and four weeks after the last treatment. The number and pattern of&#xD;
      injections will be based on the area (cm x cm) of submental fat at baseline. At each visit&#xD;
      the subjects will also undergo an examination of the treatment area, collection of vital&#xD;
      signs and questioning about possible adverse events (AEs).&#xD;
&#xD;
      The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit&#xD;
      and an End of Study Visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">June 2, 2017</completion_date>
  <primary_completion_date type="Actual">June 2, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety as measured by number of subjects with adverse events.</measure>
    <time_frame>12 weeks (Baseline through 4 weeks post last dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as measured by the number of subjects with abnormal post baseline shifts in laboratory results.</measure>
    <time_frame>12 weeks (Baseline through 4 weeks post last dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the patient reported submental bulging scale.</measure>
    <time_frame>12 weeks (Baseline through 4 weeks post last dose)</time_frame>
    <description>The self-rating scale is 5-point scale that the subject evaluates their submental fat.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the clinician reported submental bulging scale</measure>
    <time_frame>12 weeks (Baseline through 4 weeks post last dose)</time_frame>
    <description>The clinician scale is 5-point rating scale in which the clinician evaluates the subject's submental fat.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in submental fat thickness measured with calipers (mm).</measure>
    <time_frame>12 weeks (Baseline through 4 weeks post last dose)</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Submental Fat</condition>
  <arm_group>
    <arm_group_label>Active High</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.2 mcg SX/mL Total Weekly Dose: up to 3.0 mcg SX</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.02 mcg SX/mL Total Weekly Dose: up to 0.3 mcg SX</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for LIPO 202 (Salmeterol Xinafoate for Injection)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LIPO-202</intervention_name>
    <arm_group_label>Active High</arm_group_label>
    <arm_group_label>Active Low</arm_group_label>
    <other_name>Salmeterol Xinafoate for Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for LIPO-202</intervention_name>
    <description>Lyophile manufactured to mimic LIPO-202 lyophile.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males or non-pregnant females;&#xD;
&#xD;
          2. Capable of providing written, informed consent; and ,&#xD;
&#xD;
          3. Have submental bulging that is evaluated by the Investigator as &quot;Moderate&quot; or &quot;Large&quot;.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of prior treatment to reduce submental bulging;&#xD;
&#xD;
          2. History of derm fillers, chemical peels, or laser or radio frequency procedures in the&#xD;
             neck/chin area within 12 months of screening;&#xD;
&#xD;
          3. History of botulinum toxin in the neck/chin area within 6 months of screening;&#xD;
&#xD;
          4. Any skin conditions (including, but not limited to: skin infections, psoriasis,&#xD;
             eczema, keloids, tattoos or hypertrophic or tethered scars) or history of trauma in&#xD;
             the treatment area that may affect study procedures;&#xD;
&#xD;
          5. A score of 4 (Extreme Laxity) on the Skin Laxity Assessment Scale at Visit 1&#xD;
             (Screening);&#xD;
&#xD;
          6. Any known hypersensitivity to the study drug and/or any of the components;&#xD;
&#xD;
          7. Prior or current enrollment in any Lithera/Neothetics sponsored LIPO-102/LIPO-202&#xD;
             study;&#xD;
&#xD;
          8. Concurrently enrolled in another investigational drug or device study or used any&#xD;
             experimental or investigational drug or device within 30 days of screening;&#xD;
&#xD;
          9. Female subject who is pregnant or lactating;&#xD;
&#xD;
         10. Any medical condition that in the opinion of the Investigator might complicate study&#xD;
             procedures or assessments or jeopardize the subject's safety, including, but not&#xD;
             limited to:&#xD;
&#xD;
               1. any bleeding or connective tissue disorders;&#xD;
&#xD;
               2. any clinically significant kidney or liver disease;&#xD;
&#xD;
               3. any untreated thyroid disease;&#xD;
&#xD;
               4. asthma, COPD, diabetes (Type I and II) or cardiovascular disease&#xD;
&#xD;
               5. history of major surgery within 30 days prior to randomization, or planned&#xD;
                  surgery during the study period;&#xD;
&#xD;
         11. Used drugs with anticoagulant activity (including aspirin) within 14 days prior to&#xD;
             randomization, β adrenergic receptor agonists or blockers, strong CYP3A inhibitors, or&#xD;
             nonpotassium sparing diuretics (e.g., loop or thiazide diuretics) within 28 days prior&#xD;
             to randomization;&#xD;
&#xD;
         12. Used tricyclic antidepressants or monoamine oxidase inhibitor medications within 14&#xD;
             days prior to randomization;&#xD;
&#xD;
         13. Unlikely or unable to adhere to the study visit schedule or comply with protocol&#xD;
             procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Piacquadio, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Consultant, Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Testing of Beverly Hills</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ablon Skin Institute And Research Center</name>
      <address>
        <city>Manhattan Beach</city>
        <state>California</state>
        <zip>90266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AboutSkin Research</name>
      <address>
        <city>Greenwood Village</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Research Institute</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grekin Skin Institute</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Clinical Study Center</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Research</name>
      <address>
        <city>Washington</city>
        <state>Missouri</state>
        <zip>63090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Specialists, PC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juva Skin &amp; Laser Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westlake Dermatology Clinical Research Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78746</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>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>submental</keyword>
  <keyword>Salmeterol Xinafoate</keyword>
  <keyword>LIPO-202</keyword>
  <keyword>bulge</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salmeterol Xinafoate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005717
org study id: LIPO-202-CL-31
nct id: NCT03005717
lead sponsor: 
has dmc: No
Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to
      evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on
      submental bulging due to subcutaneous fat. Approximately 150 participants of either gender
      who have a "Moderate Bulge" or "Large Bulge" in the submental fat (on Patient-Reported
      Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS])
      will be recruited for this study.
Potential subjects will present and complete the Screening Visit. All qualifying subjects
      will be randomized to one of three treatment groups and treated with up to 30 subcutaneous
      injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon
      completion of treatment visits, subject will return to the clinic for a follow-up visit and
      end of study visit, one and four weeks after the last treatment. The number and pattern of
      injections will be based on the area (cm x cm) of submental fat at baseline. At each visit
      the subjects will also undergo an examination of the treatment area, collection of vital
      signs and questioning about possible adverse events (AEs).

      The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit
      and an End of Study Visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Safety as measured by number of subjects with adverse events.
time frame: 12 weeks (Baseline through 4 weeks post last dose)
measure: Safety as measured by the number of subjects with abnormal post baseline shifts in laboratory results.
time frame: 12 weeks (Baseline through 4 weeks post last dose)
measure: Change from baseline in the patient reported submental bulging scale.
time frame: 12 weeks (Baseline through 4 weeks post last dose)
description: The self-rating scale is 5-point scale that the subject evaluates their submental fat.
measure: Change from baseline in the clinician reported submental bulging scale
time frame: 12 weeks (Baseline through 4 weeks post last dose)
description: The clinician scale is 5-point rating scale in which the clinician evaluates the subject's submental fat.
measure: Change in submental fat thickness measured with calipers (mm).
time frame: 12 weeks (Baseline through 4 weeks post last dose)
arm group label: Active High
arm group type: Experimental
description: Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.2 mcg SX/mL Total Weekly Dose: up to 3.0 mcg SX
arm group label: Active Low
arm group type: Experimental
description: Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.02 mcg SX/mL Total Weekly Dose: up to 0.3 mcg SX
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for LIPO 202 (Salmeterol Xinafoate for Injection)
intervention type: Drug
intervention name: LIPO-202
arm group label: Active High
arm group label: Active Low
other name: Salmeterol Xinafoate for Injection
intervention type: Drug
intervention name: Placebo for LIPO-202
description: Lyophile manufactured to mimic LIPO-202 lyophile.
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Daniel Piacquadio, MD
role: Study Chair
affiliation: Consultant, Therapeutics, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Salmeterol Xinafoate
sharing ipd: No