<clinical_study>
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    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/NCT03818256</url>
  </required_header>
  <id_info>
    <org_study_id>CORT118335-876</org_study_id>
    <nct_id>NCT03818256</nct_id>
  </id_info>
  <brief_title>This Phase 2, Double Blind, Placebo-controlled, Randomized Study is to Assess the Safety and Efficacy of Miricorilant in Obese Adult With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications.</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corcept Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corcept Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and&#xD;
      efficacy of miricorilant in obese adult with schizophrenia treated with antipsychotic&#xD;
      medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled study that will assess the safety,&#xD;
      efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who&#xD;
      are currently taking oral or injectable atypical antipsychotic medication.&#xD;
&#xD;
      Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to&#xD;
      receive 600 mg miricorilant or placebo for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2019</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>
    <masking_description>Double Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo</measure>
    <time_frame>Baseline Day 1 to Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation</measure>
    <time_frame>Up to Follow-up Visit (up to Week 16)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients achieving more than or equal to 5% weight loss</measure>
    <time_frame>Baseline Day 1 to week 12</time_frame>
    <description>Percentage of patients achieving more than or equal to 5% weight loss for 600 mg miricorilant versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12</measure>
    <time_frame>Baseline Day 1 to week 12</time_frame>
    <description>Change in insulin resistance (HOMA-IR) for 600 mg miricorilant versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in waist-to-hip ratio at Week 12</measure>
    <time_frame>Baseline Day1 to week 12</time_frame>
    <description>600 mg Miricorilant versus placebo</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Antipsychotic-induced Weight Gain (AIWG)</condition>
  <arm_group>
    <arm_group_label>CORT118335- 600 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive 600 mg miricorilant for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Miricorilant</intervention_name>
    <description>Miricorilant 600mg</description>
    <arm_group_label>CORT118335- 600 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Miricorilant</intervention_name>
    <description>Placebo tablets for once daily oral dosing</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of schizophrenia or bipolar disorder&#xD;
&#xD;
          -  Are currently taking oral or injectable atypical antipsychotic medication (except&#xD;
             clozapine) and must have documented weight gain while on these medications&#xD;
&#xD;
          -  Must be on a stable dose of medication for 1 month prior to screening&#xD;
&#xD;
          -  Are able to successfully complete placebo tablet swallow test&#xD;
&#xD;
          -  Have a BMI ≥30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a history of a medical condition affecting body weight (e.g., poorly controlled&#xD;
             hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating;&#xD;
             or polycystic ovary syndrome).&#xD;
&#xD;
          -  Have poorly controlled diabetes mellitus&#xD;
&#xD;
          -  Have poorly controlled hypertension&#xD;
&#xD;
          -  Have a history of hypotension&#xD;
&#xD;
          -  Have a history of orthostatic hypotension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kavita Juneja, MD</last_name>
    <role>Study Director</role>
    <affiliation>Corcept Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 143</name>
      <address>
        <city>Bentonville</city>
        <state>Arkansas</state>
        <zip>72712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 249</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 153</name>
      <address>
        <city>Culver City</city>
        <state>California</state>
        <zip>90230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site # 239</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 134</name>
      <address>
        <city>Lemon Grove</city>
        <state>California</state>
        <zip>91945</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 126</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 163</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 229</name>
      <address>
        <city>Rancho Cucamonga</city>
        <state>California</state>
        <zip>91730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 150</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 202</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 144</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 241</name>
      <address>
        <city>Okeechobee</city>
        <state>Florida</state>
        <zip>34972</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 140</name>
      <address>
        <city>Lincolnwood</city>
        <state>Illinois</state>
        <zip>60712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 146</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 138</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>20161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 151</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 216</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 181</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 107</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 235</name>
      <address>
        <city>Media</city>
        <state>Pennsylvania</state>
        <zip>19063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 206</name>
      <address>
        <city>DeSoto</city>
        <state>Texas</state>
        <zip>75115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 066</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 165</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 139</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 137</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antipsychotic-induced weight gain (AIWG)</keyword>
  <keyword>Obesity</keyword>
  <keyword>Weight Gain</keyword>
  <keyword>Mental disorders</keyword>
  <keyword>Schizophrenia</keyword>
  <keyword>Risperidone</keyword>
  <keyword>Quetiapine</keyword>
  <keyword>Olanzapine</keyword>
  <keyword>Bipolar Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Gain</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT03818256
org study id: CORT118335-876
nct id: NCT03818256
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and
      efficacy of miricorilant in obese adult with schizophrenia treated with antipsychotic
      medications.
This is a randomized, double-blind, placebo-controlled study that will assess the safety,
      efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who
      are currently taking oral or injectable atypical antipsychotic medication.

      Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to
      receive 600 mg miricorilant or placebo for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Double Blind
measure: Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo
time frame: Baseline Day 1 to Week 12
measure: Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation
time frame: Up to Follow-up Visit (up to Week 16)
measure: Percentage of patients achieving more than or equal to 5% weight loss
time frame: Baseline Day 1 to week 12
description: Percentage of patients achieving more than or equal to 5% weight loss for 600 mg miricorilant versus placebo
measure: Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12
time frame: Baseline Day 1 to week 12
description: Change in insulin resistance (HOMA-IR) for 600 mg miricorilant versus placebo
measure: Change from baseline in waist-to-hip ratio at Week 12
time frame: Baseline Day1 to week 12
description: 600 mg Miricorilant versus placebo
arm group label: CORT118335- 600 mg
arm group type: Experimental
description: Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive 600 mg miricorilant for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks.
intervention type: Drug
intervention name: Miricorilant
description: Miricorilant 600mg
arm group label: CORT118335- 600 mg
intervention type: Drug
intervention name: Miricorilant
description: Placebo tablets for once daily oral dosing
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kavita Juneja, MD
role: Study Director
affiliation: Corcept Therapeutics
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country: United States
responsible party type: Sponsor
mesh term: Weight Gain
mesh term: Schizophrenia
mesh term: Bipolar Disorder