<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/NCT03792555</url>
  </required_header>
  <id_info>
    <org_study_id>CRN00808-02</org_study_id>
    <secondary_id>2018-001833-42</secondary_id>
    <nct_id>NCT03792555</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)</brief_title>
  <official_title>A Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly That Are Responders to Octreotide LAR or Lanreotide Depot (ACROBAT Evolve)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Crinetics Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Crinetics Pharmaceuticals Inc.</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>
      A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to&#xD;
      evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an&#xD;
      oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with&#xD;
      acromegaly that are responders to octreotide LAR or lanreotide depot.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">August 12, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects who meet responder criteria (based on the mean of two consecutive insulin-like growth factor-1 [IGF-1] measurements ≤ upper limit of normal [ULN])</measure>
    <time_frame>13 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in IGF-1 levels</measure>
    <time_frame>From Week 10 to Week 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in growth hormone (GH) levels</measure>
    <time_frame>From Week 8 to Week 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient assessed symptoms of acromegaly</measure>
    <time_frame>From Week 10 to Week 13</time_frame>
    <description>Total score computed by adding each of the individual acromegaly symptom intensities (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, numbness or tingling).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Acromegaly</condition>
  <arm_group>
    <arm_group_label>Paltusotine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paltusotine</intervention_name>
    <description>Paltusotine, capsules, once daily by mouth</description>
    <arm_group_label>Paltusotine</arm_group_label>
    <other_name>CRN00808</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, capsules, once daily by mouth</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects 18 to 70 years of age&#xD;
&#xD;
          2. Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR&#xD;
             or lanreotide depot&#xD;
&#xD;
          3. Females must be non-pregnant and non-lactating, and either surgically sterile,&#xD;
             post-menopausal, or using effective method(s) of birth control&#xD;
&#xD;
          4. Willing to provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment naïve acromegaly subjects&#xD;
&#xD;
          2. Prior treatment with paltusotine&#xD;
&#xD;
          3. Pituitary surgery within 6 months prior to Screening or radiation therapy at any time&#xD;
             prior to the study entry. Pituitary radiation therapy (within 3 to 4 years or more&#xD;
             than 4 years prior to study entry) with recently documented elevated IGF-1 may be&#xD;
             eligible.&#xD;
&#xD;
          4. History or presence of malignancy except adequately treated basal cell and squamous&#xD;
             cell carcinomas of the skin within the past 5 years.&#xD;
&#xD;
          5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is&#xD;
             longer&#xD;
&#xD;
          6. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C&#xD;
             antibody (HCV-Ab) or has a history of a positive result&#xD;
&#xD;
          7. History of alcohol or substance abuse in the past 12 months&#xD;
&#xD;
          8. Any condition that in the opinion of the investigator would jeopardize the subject's&#xD;
             appropriate participation in this study&#xD;
&#xD;
          9. Cardiovascular conditions or medications associated with prolonged QT or those which&#xD;
             predispose subjects to heart rhythm abnormalities.&#xD;
&#xD;
         10. Subjects with symptomatic cholelithiasis&#xD;
&#xD;
         11. Subjects with clinically significant abnormal findings during the Screening Period,&#xD;
             and any other medical condition(s) or laboratory findings that, in the opinion of the&#xD;
             Investigator, might jeopardize the subject's safety or ability to complete the study&#xD;
&#xD;
         12. Subjects who have been taking the following prior medications: pegvisomant (within the&#xD;
             last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR&#xD;
             (within the last 6 months)&#xD;
&#xD;
         13. Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a&#xD;
             dose higher than 120 mg&#xD;
&#xD;
         14. Subjects who usually take octreotide LAR or lanreotide depot less frequently than&#xD;
             every 4 weeks (e.g. every 6 weeks or 8 weeks)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Keck Medical Center of USC University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Gonda Diabetes Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OHSU Northwest Pituitary Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Endocrinology Associates</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane &amp; Women's Hospital</name>
      <address>
        <city>Herston</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keogh Institute for Medical Research</name>
      <address>
        <city>Nedlands</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CETI - Centro de Estudos em Terapias Inovadoras</name>
      <address>
        <city>Curitiba</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia</name>
      <address>
        <city>Rio De Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPQuali Pesquisa Clinica</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMU Clinic of University of Munich</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MEDICOVER Neuroendokrinologie</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;Evangelismos&quot;</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;Gennimatas&quot;</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;Laiko&quot;</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;Ippokratio&quot;</name>
      <address>
        <city>Thessaloníki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Health Center, Division of Endocrinology</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis University Faculty of Medicine</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pécs Medical School</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita Vita-Salute San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Federico II</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waitemata District Health Board, North Shore Hospital</name>
      <address>
        <city>Takapuna</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrine, Diabetes and Research Centre, Wellington Hospital</name>
      <address>
        <city>Wellington</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Nowoczesnch Terapii &quot;Dobry Lekarz&quot;</name>
      <address>
        <city>Kraków</city>
        <zip>31-011</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Centre of Postgraduate Medical Education</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Endocrinology &quot;C. I. Parhon&quot;</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Clinical County Hospital, Endocrinology Clinic</name>
      <address>
        <city>Cluj-Napoca</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Centre of Vojvodina, Clinic for Endocrinology, Diabetes and Metabolic Diseases</name>
      <address>
        <city>Novi Sad</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Bratislava</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Endocrinology and Diabetology</name>
      <address>
        <city>Ľubochňa</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Coventry and Warwickshire NHS Trust</name>
      <address>
        <city>Coventry</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts and the London School of Medicine</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salford Royal NHS Foundation Trust</name>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <disposition_first_submitted>July 13, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>July 13, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 16, 2021</disposition_first_posted>
  <last_update_submitted>July 13, 2021</last_update_submitted>
  <last_update_submitted_qc>July 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acromegaly</keyword>
  <keyword>ACROBAT</keyword>
  <keyword>EVOLVE</keyword>
  <keyword>Paltusotine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acromegaly</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03792555
org study id: CRN00808-02
secondary id: 2018-001833-42
nct id: NCT03792555
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to
      evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an
      oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with
      acromegaly that are responders to octreotide LAR or lanreotide depot.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Proportion of subjects who meet responder criteria (based on the mean of two consecutive insulin-like growth factor-1 [IGF-1] measurements ≤ upper limit of normal [ULN])
time frame: 13 Weeks
measure: Change in IGF-1 levels
time frame: From Week 10 to Week 13
measure: Change in growth hormone (GH) levels
time frame: From Week 8 to Week 13
measure: Change in patient assessed symptoms of acromegaly
time frame: From Week 10 to Week 13
description: Total score computed by adding each of the individual acromegaly symptom intensities (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, numbness or tingling).
arm group label: Paltusotine
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Paltusotine
description: Paltusotine, capsules, once daily by mouth
arm group label: Paltusotine
other name: CRN00808
intervention type: Drug
intervention name: Placebo
description: Placebo, capsules, once daily by mouth
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
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country: Australia
country: Brazil
country: Germany
country: Greece
country: Hungary
country: Italy
country: New Zealand
country: Poland
country: Romania
country: Serbia
country: Slovakia
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Acromegaly
sharing ipd: No