xml: <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/NCT06039826</url>
    </required_header>
    <id_info>
      <org_study_id>18533</org_study_id>
      <secondary_id>J1I-MC-GZBV</secondary_id>
      <nct_id>NCT06039826</nct_id>
    </id_info>
    <brief_title>A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese</brief_title>
    <official_title>A Phase 1 Study to Investigate the Effect of LY3437943 on the Pharmacokinetics of the Combined Oral Contraceptive Ethinyl Estradiol and Drospirenone in Female Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eli Lilly and Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eli Lilly and Company</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>
        The main purpose of this study is to determine the effect of LY3437943 when administered&#xD;
        subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and&#xD;
        drospirenone in the blood stream in postmenopausal female participants who are overweight or&#xD;
        obese. The safety and tolerability of LY3437943 when administered with COC will also be&#xD;
        evaluated. This study will last up to approximately 29 weeks for each participant.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">January 2, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol</measure>
      <time_frame>Predose on Day 1 up to 144 days postdose</time_frame>
      <description>PK: AUC0-24 of Ethinyl Estradiol</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol</measure>
      <time_frame>Predose on Day 1 up to 144 days postdose</time_frame>
      <description>PK: Cmax of Ethinyl Estradiol</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol</measure>
      <time_frame>Predose on Day 1 up to 144 days postdose</time_frame>
      <description>PK: Tmax of Ethinyl Estradiol</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone</measure>
      <time_frame>Predose on Day 1 up to 144 days postdose</time_frame>
      <description>PK: AUC0-24 of Drospirenone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK: Maximum Observed Concentration (Cmax) of Drospirenone</measure>
      <time_frame>Predose on Day 1 up to 144 days postdose</time_frame>
      <description>PK: Cmax of Drospirenone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone</measure>
      <time_frame>Predose on Day 1 up to 144 days postdose</time_frame>
      <description>PK: Tmax of Drospirenone</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">39</enrollment>
    <condition>Overweight</condition>
    <arm_group>
      <arm_group_label>LY3437943 + Combined Oral Contraceptive (COC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LY3437943</intervention_name>
      <description>Administered SC.</description>
      <arm_group_label>LY3437943 + Combined Oral Contraceptive (COC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ethinyl Estradiol</intervention_name>
      <description>Administered orally</description>
      <arm_group_label>LY3437943 + Combined Oral Contraceptive (COC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Drospirenone</intervention_name>
      <description>Administered orally</description>
      <arm_group_label>LY3437943 + Combined Oral Contraceptive (COC)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Postmenopausal female participants&#xD;
  &#xD;
            -  Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared&#xD;
               (kg/m²)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have an unstable disease or a disease constituting a risk when taking the study&#xD;
               intervention.&#xD;
  &#xD;
            -  Have significant renal insufficiency&#xD;
  &#xD;
            -  Have an important gastro-esophageal reflux disease, pyloric stenosis, gastroparesis or&#xD;
               a history of gastric bypass surgery.&#xD;
  &#xD;
            -  Have a history or presence of chronic or idiopathic acute pancreatitis.&#xD;
  &#xD;
            -  Have a history of severe clinically significant multiple or severe drug allergies.&#xD;
  &#xD;
            -  Have a personal or family history of medullary thyroid carcinoma or have multiple&#xD;
               endocrine neoplasia syndrome type 2&#xD;
  &#xD;
            -  Have had any malignancy within the past 5 years except for basal cell or squamous&#xD;
               epithelial carcinomas of the skin or in situ carcinoma of the cervix that have been&#xD;
               resected with no evidence of metastatic disease for 3 years&#xD;
  &#xD;
            -  Have any form of diabetes mellitus other than type 2&#xD;
  &#xD;
            -  Have type 2 diabetes with HbA1c greater than or equal to 10% at screening&#xD;
  &#xD;
            -  Have received an oral or transdermal patch hormone replacement therapy (HRT) within&#xD;
               the last 1 month prior to screening or depot injectable HRT within the last 6 months&#xD;
  &#xD;
            -  Have received any investigational drug within the last month or 5 half-lives of this&#xD;
               drug, whichever is longer, prior to screening. If the half-life of the previous&#xD;
               investigational drug is unknown, the washout period should be at least 3 months before&#xD;
               screening&#xD;
  &#xD;
            -  Show evidence of HIV infection or positive HIV antibodies&#xD;
  &#xD;
            -  Have evidence of, or test positive for, anti-hepatitis C virus antibody unless a&#xD;
               confirmatory test for hepatitis C virus RNA is negative&#xD;
  &#xD;
            -  Test positive for hepatitis B surface antigen. In case a hepatitis B virus DNA test&#xD;
               was also performed recently and is positive, the participant should be excluded&#xD;
               independently of the hepatitis B surface antigen test result. The hepatitis B core&#xD;
               antibody test is not used to assess eligibility&#xD;
  &#xD;
            -  Have acute or chronic hepatitis, or signs and symptoms of any other liver disease, or&#xD;
               with significant abnormalities in laboratory liver tests&#xD;
  &#xD;
            -  Have a fasting triglyceride level greater than 500 mg/dL at screening&#xD;
  &#xD;
            -  Used any nicotine product including tobacco or nicotine replacement products within 1&#xD;
               month prior to screening or a positive cotinine test at screening. Are unable or&#xD;
               unwilling to refrain from using such products during the study&#xD;
  &#xD;
            -  Have donated at least 450 mL of blood within 8 weeks before screening or intend to&#xD;
               donate blood during the study&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
      <role>Study Director</role>
      <affiliation>Eli Lilly and Company</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or</last_name>
      <phone>1-317-615-4559</phone>
      <email>ClinicalTrials.gov@Lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Qps-Mra, Llc</name>
        <address>
          <city>South Miami</city>
          <state>Florida</state>
          <zip>33143</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>305-722-0970</phone>
      </contact>
      <investigator>
        <last_name>Sandra Pagnussat</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ICON Early Phase Services</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78209</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>210-875-6791</phone>
      </contact>
      <investigator>
        <last_name>Cassandra Key</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pharmacokinetics</keyword>
    <keyword>Obesity</keyword>
    <keyword>Oral Contraceptive</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>Drospirenone</mesh_term>
      <mesh_term>Ethinyl Estradiol</mesh_term>
      <mesh_term>Estradiol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039826
  org study id: 18533
  secondary id: J1I-MC-GZBV
  nct id: NCT06039826
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The main purpose of this study is to determine the effect of LY3437943 when administered
        subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and
        drospirenone in the blood stream in postmenopausal female participants who are overweight or
        obese. The safety and tolerability of LY3437943 when administered with COC will also be
        evaluated. This study will last up to approximately 29 weeks for each participant.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol
  time frame: Predose on Day 1 up to 144 days postdose
  description: PK: AUC0-24 of Ethinyl Estradiol
  measure: PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol
  time frame: Predose on Day 1 up to 144 days postdose
  description: PK: Cmax of Ethinyl Estradiol
  measure: PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol
  time frame: Predose on Day 1 up to 144 days postdose
  description: PK: Tmax of Ethinyl Estradiol
  measure: PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone
  time frame: Predose on Day 1 up to 144 days postdose
  description: PK: AUC0-24 of Drospirenone
  measure: PK: Maximum Observed Concentration (Cmax) of Drospirenone
  time frame: Predose on Day 1 up to 144 days postdose
  description: PK: Cmax of Drospirenone
  measure: PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone
  time frame: Predose on Day 1 up to 144 days postdose
  description: PK: Tmax of Drospirenone
  arm group label: LY3437943 + Combined Oral Contraceptive (COC)
  arm group type: Experimental
  description: The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).
  intervention type: Drug
  intervention name: LY3437943
  description: Administered SC.
  arm group label: LY3437943 + Combined Oral Contraceptive (COC)
  intervention type: Drug
  intervention name: Ethinyl Estradiol
  description: Administered orally
  arm group label: LY3437943 + Combined Oral Contraceptive (COC)
  intervention type: Drug
  intervention name: Drospirenone
  description: Administered orally
  arm group label: LY3437943 + Combined Oral Contraceptive (COC)
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 40 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
  role: Study Director
  affiliation: Eli Lilly and Company
  last name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  phone: 1-317-615-4559
  email: ClinicalTrials.gov@Lilly.com
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Overweight
  mesh term: Drospirenone
  mesh term: Ethinyl Estradiol
  mesh term: Estradiol
  sharing ipd: No