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/NCT06000891</url>
    </required_header>
    <id_info>
      <org_study_id>ZP7570-23012</org_study_id>
      <secondary_id>2022-500614-26</secondary_id>
      <nct_id>NCT06000891</nct_id>
    </id_info>
    <brief_title>A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570</brief_title>
    <official_title>A Randomised, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Administered in Subjects With Overweight or Obesity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zealand Pharma</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Profil Institut für Stoffwechselforschung GmbH</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Zealand Pharma</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The trial is a Phase 1, single-centre, randomised and double-blind within cohorts,&#xD;
        placebo-controlled, sequential multiple ascending dose trial including three cohorts in a&#xD;
        semi-parallel design in overweight and obese but otherwise healthy subjects, randomised to&#xD;
        ZP7570 or placebo within each cohort where the observational period is 18 weeks. All subjects&#xD;
        will be dosed for 13 weeks with ascending weekly doses of ZP7570 at dose levels with&#xD;
        corresponding volume of placebo.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        ZP7570 is a dual GLP-1R/GLP-2R agonist in clinical development for weight management. The&#xD;
        overall purpose of this trial is to evaluate the safety and tolerability when applying dose&#xD;
        titration of ascending doses of ZP7570 and at steady state.&#xD;
  &#xD;
        The trial is a Phase 1, single-centre, randomised and double-blind within cohorts,&#xD;
        placebo-controlled, sequential multiple ascending dose trial including three cohorts in a&#xD;
        semi-parallel design in overweight and obese but otherwise healthy subjects, randomised to&#xD;
        ZP7570 or placebo. All subjects will be dosed with ascending weekly doses of ZP7570 with&#xD;
        corresponding volume of placebo. After informed consent has been obtained, eligibility of the&#xD;
        subjects will be assessed during a screening Visit (V1). Additional tests to assess safety&#xD;
        and PK and PD will take place during in-house visits and ambulatory visits.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">July 4, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 4, 2024</primary_completion_date>
    <phase>Phase 1</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>
      <intervention_model_description>The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in a semi-parallel design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Everyone involved in the conduct of the trial will be blinded until after completion of the trial and the final data review</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of treatment emergent adverse events (TEAEs)</measure>
      <time_frame>Day 1 to Day 127</time_frame>
      <description>Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 127)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics endpoints related to ZP7570 exposure</measure>
      <time_frame>Area under the drug concentration curve from baseline to 18 weeks (Day 1 predose to Day 127)</time_frame>
      <description>Pharmacokinetics: Area under the plasma concentration curve from baseline (Day 1, predose) to 18 weeks (Day 127) .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics endpoints related to ZP7570 exposure</measure>
      <time_frame>Maximum drug concentration (Cmax) from baseline to 18 weeks (Day 1, predose to Day 127)</time_frame>
      <description>Pharmacokinetics - Maximum plasma concentration (peak) from baseline (Day 1, predose) to 18 weeks (Day 127).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics endpoints related to ZP7570 exposure</measure>
      <time_frame>Time to maximum plasma concentration from baseline to 18 weeks (Day 1, predose to Day 127)</time_frame>
      <description>Pharmacokinetics - Time to maximum plasma concentration (Tmax) from baseline (Day 1, predose) to 18 weeks (Day 127).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics endpoints related to ZP7570 exposure</measure>
      <time_frame>Elimination rate constant from baseline to 18 weeks (Day 1, predose to Day 127)</time_frame>
      <description>Pharmacokinetics - Elimination rate constant (λz) from baseline (Day 1, predose) to 18 weeks (Day 127).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics endpoints related to ZP7570 exposure</measure>
      <time_frame>Elimination half-life from baseline to 18 weeks (Day 1, predose to Day 127)</time_frame>
      <description>Pharmacokinetics - Elimination half-life (t1/2) from baseline (Day 1, predose) to 18 weeks (Day 127).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics endpoints related to ZP7570 exposure</measure>
      <time_frame>Apparent volume of distribution from baseline to 18 weeks (Day 1, predose to Day 127))</time_frame>
      <description>Pharmacokinetics - Apparent volume of distribution (Vz/f) during the terminal phase from baseline (Day 1, predose) to 18 weeks (Day 127).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics endpoints related to ZP7570 exposure</measure>
      <time_frame>Apparent total clearance of the drug from plasma from baseline to 18 weeks (Day 1, predose to Day 127)</time_frame>
      <description>Pharmacokinetics - Apparent total clearance of the drug from plasma (Cl/f) from baseline (Day 1, predose) to 18 weeks (Day 127).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics endpoints related to ZP7570 exposure</measure>
      <time_frame>Trough concentration measured from baseline to 18 weeks (Day 1, predose to Day 127)</time_frame>
      <description>Pharmacokinetics - Trough concentration measured predose (Ctrough) from baseline (Day 1, predose) to 18 weeks (Day 127).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change in body weight</measure>
      <time_frame>Day 1 and Day 92</time_frame>
      <description>Absolute change in body weight in kilogram (kg) from baseline (Day 1) to end of treatment (Day 92)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent change in body weight</measure>
      <time_frame>Day 1 and Day 92</time_frame>
      <description>Percent change in body weight in percent (%) from baseline (Day 1) to end of treatment (Day 92)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Safety and Tolerability</condition>
    <arm_group>
      <arm_group_label>ZP7570</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>ZP7570 for subcutaneous once-weekly injection.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo for subcutaneous once-weekly injection. Corresponding volume matching active treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ZP7570</intervention_name>
      <description>13 once-weekly subcutaneous injections</description>
      <arm_group_label>ZP7570</arm_group_label>
      <other_name>GLP-1/GLP-2 agonist</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>13 once-weekly subcutaneous injections</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 18 and 64 years, both inclusive.&#xD;
  &#xD;
            -  Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive.&#xD;
  &#xD;
            -  In overall good health according to age (medical history, physical and neurological&#xD;
               examination, vital signs, and laboratory assessments), as judged by the investigator&#xD;
               at screening.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of gastrointestinal (GI) diseases including functional complaints that could&#xD;
               interfere with the pharmacokinetics of the IMP or auxiliary medicinal product&#xD;
               (acetaminophen) of the trial.&#xD;
  &#xD;
            -  Any relevant abnormal renal parameters in the following ranges:&#xD;
  &#xD;
          Serum creatinine above UNL+10% or normalised estimated glomerular filtration rate (eGFR)&#xD;
          below 60.0 l/min/1.73m2, as defined by CKD-EPI.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>2. Male subject or female subject of non-child-bearing potential A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile due to hysterectomy, or bilateral salpingectomy, or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ulrike Hoevelmann, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Profil, Neuss, Germany</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anne Sager, CTM</last_name>
      <phone>+45 5060</phone>
      <phone_ext>3786</phone_ext>
      <email>ASager@zealandpharma.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Simone Matern</last_name>
      <phone>+4921314018</phone>
      <phone_ext>493</phone_ext>
      <email>simone.matern@profil.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Profil Institut für Stoffwechselforschung GmbH</name>
        <address>
          <city>Neuss</city>
          <state>North Rhine-Westphalia</state>
          <zip>41460</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>GLP-1/GLP-2 agonist, overweight, obesity</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data collection and handling of clinical trial data at the trial site has been designed to limit the possibility of identifying trial subjects from their data. To this end, pseudonymised data will be used wherever possible and the collection of demographic information that could be used for re-identification of subjects will be restricted to the extent necessary for the conduct of this trial.</ipd_description>
    </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/NCT06000891
  org study id: ZP7570-23012
  secondary id: 2022-500614-26
  nct id: NCT06000891
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The trial is a Phase 1, single-centre, randomised and double-blind within cohorts,
        placebo-controlled, sequential multiple ascending dose trial including three cohorts in a
        semi-parallel design in overweight and obese but otherwise healthy subjects, randomised to
        ZP7570 or placebo within each cohort where the observational period is 18 weeks. All subjects
        will be dosed for 13 weeks with ascending weekly doses of ZP7570 at dose levels with
        corresponding volume of placebo.
  ZP7570 is a dual GLP-1R/GLP-2R agonist in clinical development for weight management. The
        overall purpose of this trial is to evaluate the safety and tolerability when applying dose
        titration of ascending doses of ZP7570 and at steady state.
  
        The trial is a Phase 1, single-centre, randomised and double-blind within cohorts,
        placebo-controlled, sequential multiple ascending dose trial including three cohorts in a
        semi-parallel design in overweight and obese but otherwise healthy subjects, randomised to
        ZP7570 or placebo. All subjects will be dosed with ascending weekly doses of ZP7570 with
        corresponding volume of placebo. After informed consent has been obtained, eligibility of the
        subjects will be assessed during a screening Visit (V1). Additional tests to assess safety
        and PK and PD will take place during in-house visits and ambulatory visits.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in a semi-parallel design
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Everyone involved in the conduct of the trial will be blinded until after completion of the trial and the final data review
  measure: Incidence of treatment emergent adverse events (TEAEs)
  time frame: Day 1 to Day 127
  description: Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 127)
  measure: Pharmacokinetics endpoints related to ZP7570 exposure
  time frame: Area under the drug concentration curve from baseline to 18 weeks (Day 1 predose to Day 127)
  description: Pharmacokinetics: Area under the plasma concentration curve from baseline (Day 1, predose) to 18 weeks (Day 127) .
  measure: Pharmacokinetics endpoints related to ZP7570 exposure
  time frame: Maximum drug concentration (Cmax) from baseline to 18 weeks (Day 1, predose to Day 127)
  description: Pharmacokinetics - Maximum plasma concentration (peak) from baseline (Day 1, predose) to 18 weeks (Day 127).
  measure: Pharmacokinetics endpoints related to ZP7570 exposure
  time frame: Time to maximum plasma concentration from baseline to 18 weeks (Day 1, predose to Day 127)
  description: Pharmacokinetics - Time to maximum plasma concentration (Tmax) from baseline (Day 1, predose) to 18 weeks (Day 127).
  measure: Pharmacokinetics endpoints related to ZP7570 exposure
  time frame: Elimination rate constant from baseline to 18 weeks (Day 1, predose to Day 127)
  description: Pharmacokinetics - Elimination rate constant (λz) from baseline (Day 1, predose) to 18 weeks (Day 127).
  measure: Pharmacokinetics endpoints related to ZP7570 exposure
  time frame: Elimination half-life from baseline to 18 weeks (Day 1, predose to Day 127)
  description: Pharmacokinetics - Elimination half-life (t1/2) from baseline (Day 1, predose) to 18 weeks (Day 127).
  measure: Pharmacokinetics endpoints related to ZP7570 exposure
  time frame: Apparent volume of distribution from baseline to 18 weeks (Day 1, predose to Day 127))
  description: Pharmacokinetics - Apparent volume of distribution (Vz/f) during the terminal phase from baseline (Day 1, predose) to 18 weeks (Day 127).
  measure: Pharmacokinetics endpoints related to ZP7570 exposure
  time frame: Apparent total clearance of the drug from plasma from baseline to 18 weeks (Day 1, predose to Day 127)
  description: Pharmacokinetics - Apparent total clearance of the drug from plasma (Cl/f) from baseline (Day 1, predose) to 18 weeks (Day 127).
  measure: Pharmacokinetics endpoints related to ZP7570 exposure
  time frame: Trough concentration measured from baseline to 18 weeks (Day 1, predose to Day 127)
  description: Pharmacokinetics - Trough concentration measured predose (Ctrough) from baseline (Day 1, predose) to 18 weeks (Day 127).
  measure: Absolute change in body weight
  time frame: Day 1 and Day 92
  description: Absolute change in body weight in kilogram (kg) from baseline (Day 1) to end of treatment (Day 92)
  measure: Percent change in body weight
  time frame: Day 1 and Day 92
  description: Percent change in body weight in percent (%) from baseline (Day 1) to end of treatment (Day 92)
  arm group label: ZP7570
  arm group type: Active Comparator
  description: ZP7570 for subcutaneous once-weekly injection.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo for subcutaneous once-weekly injection. Corresponding volume matching active treatment
  intervention type: Drug
  intervention name: ZP7570
  description: 13 once-weekly subcutaneous injections
  arm group label: ZP7570
  other name: GLP-1/GLP-2 agonist
  intervention type: Drug
  intervention name: Placebo
  description: 13 once-weekly subcutaneous injections
  arm group label: Placebo
  criteria: 
  gender: All
  gender based: Yes
  gender description: 2. Male subject or female subject of non-child-bearing potential A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile due to hysterectomy, or bilateral salpingectomy, or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ulrike Hoevelmann, MD
  role: Principal Investigator
  affiliation: Profil, Neuss, Germany
  last name: Anne Sager, CTM
  phone: +45 5060
  phone ext: 3786
  email: ASager@zealandpharma.com
  last name: Simone Matern
  phone: +4921314018
  phone ext: 493
  email: simone.matern@profil.com
  facility: 
  country: Germany
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: The data collection and handling of clinical trial data at the trial site has been designed to limit the possibility of identifying trial subjects from their data. To this end, pseudonymised data will be used wherever possible and the collection of demographic information that could be used for re-identification of subjects will be restricted to the extent necessary for the conduct of this trial.