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/NCT06019559</url>
    </required_header>
    <id_info>
      <org_study_id>K-757 P006</org_study_id>
      <nct_id>NCT06019559</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833</brief_title>
    <official_title>A Randomized, Placebo-Controlled, Double-Blind 13-Week Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 in Participants Who Are Obese</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kallyope Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kallyope 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>
        This is a study to evaluate the safety and efficacy of K-757 alone and in combination with&#xD;
        K-833 versus placebo in participants who are obese.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage change from baseline in body weight (%) after 13 weeks of treatment</measure>
      <time_frame>13 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>The proportion of participants achieving ≥5% weight loss after 13 weeks of treatment</measure>
      <time_frame>13 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in body weight (kg) after 13 weeks of treatment</measure>
      <time_frame>13 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants who experienced 1 or more treatment-emergent AEs</measure>
      <time_frame>15 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants who discontinued study medication due to an AE</measure>
      <time_frame>13 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>K-757+K-833</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>K-757 alone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo to K-757 and K-833</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>K-757 and K-833</intervention_name>
      <description>Both administered orally</description>
      <arm_group_label>K-757+K-833</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>K-757 and matching placebo to K-833</intervention_name>
      <description>Both Administered orally</description>
      <arm_group_label>K-757 alone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Matching placebo to K-757 and matching placebo to K-833</intervention_name>
      <description>Both administered orally</description>
      <arm_group_label>Placebo to K-757 and K-833</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Understand the trial procedures and agree to participate by providing written informed&#xD;
               consent prior to trial related activities. Trial-related activities are any procedures&#xD;
               that are carried out as part of the trial, including activities to determine&#xD;
               suitability for the trial.&#xD;
  &#xD;
            2. Be willing and able to comply with the study schedule of visits, all trial procedures&#xD;
               and restrictions, including following study diet requirements.&#xD;
  &#xD;
            3. Be a male or female, age 18 to 70 years, inclusive, at the time of signing informed&#xD;
               consent.&#xD;
  &#xD;
            4. Have a body mass index (BMI) of 30.0 to &lt;40.0. kg/m2, inclusive.&#xD;
  &#xD;
            5. History of at least one self-reported unsuccessful dietary effort to lose body weight.&#xD;
  &#xD;
            6. Be weight stable (&lt;5% variation) over the last 3 months (by subject report).&#xD;
  &#xD;
            7. Be a nonsmoker or has smoked ≤10 cigarettes per week for at least 3 months and agrees&#xD;
               not to exceed this for the duration of study participation; has not used other&#xD;
               nicotine containing products (e.g. other forms of tobacco, nicotine patch, e&#xD;
               cigarettes, vapes) for at least 3 months and agrees to abstain from such products&#xD;
               throughout study participation.&#xD;
  &#xD;
            8. Meet the following requirements:&#xD;
  &#xD;
                 1. Is a male who agrees to all of the following:&#xD;
  &#xD;
                      -  To use an appropriate method of contraception, including a condom which must&#xD;
                         include spermicidal cream or jelly, from the first dose of study drug until&#xD;
                         14 days after the last dose of study drug. A male subject who had a&#xD;
                         vasectomy procedure must follow the same restrictions as a non vasectomized&#xD;
                         man.&#xD;
  &#xD;
                      -  If partner is pregnant, to use a condom&#xD;
  &#xD;
                      -  To not donate sperm from the first dose of study drug until 14 days after&#xD;
                         the last dose of study drug.&#xD;
  &#xD;
                    OR&#xD;
  &#xD;
                 2. Is a female who is of non-childbearing potential defined by at least 1 of the&#xD;
                    following criteria:&#xD;
  &#xD;
                      -  Postmenopausal (aged &gt;45 years and with a minimum of 12 months of&#xD;
                         spontaneous amenorrhea with a Screening serum follicle-stimulating hormone&#xD;
                         (FSH) level in the menopausal range established for the central laboratory.&#xD;
  &#xD;
                      -  Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based&#xD;
                         on the subject's recall of their medical history.&#xD;
  &#xD;
                    OR&#xD;
  &#xD;
                 3. Is a female of reproductive potential and:&#xD;
  &#xD;
                      -  agrees to not donate eggs from the first dose of study drug until 14 days&#xD;
                         after the last dose of study drug.&#xD;
  &#xD;
                      -  agrees to remain abstinent from heterosexual activity or&#xD;
  &#xD;
                      -  agrees to use (or have their partner use) a birth control method that is&#xD;
                         highly effective and has low user dependency from the first dose of study&#xD;
                         drug until 14 days after the last dose of study drug. Acceptable methods of&#xD;
                         birth control are:&#xD;
  &#xD;
                           -  Progestogen-only implant (e.g. etonogestrel implant)&#xD;
  &#xD;
                           -  Intrauterine device (IUD)&#xD;
  &#xD;
                           -  Intrauterine hormone-releasing system (IUS)&#xD;
  &#xD;
                           -  Bilateral tubal occlusion&#xD;
  &#xD;
                           -  Vasectomized partner&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Glycemia related:&#xD;
  &#xD;
            1. Has a hemoglobin A1c (HbA1c) ≥6.5% (48 mmol/mol) as measured by the central laboratory&#xD;
               at screening.&#xD;
  &#xD;
            2. Has a history of clinically significant endocrine disease including T2DM. Note: A&#xD;
               history of hypothyroidism does not require exclusion if the subject has been on a&#xD;
               stable dose of thyroid hormone replacement (thyroxine) for at least 3 months prior to&#xD;
               screening and the screening thyroid-stimulating hormone (TSH) is within the central&#xD;
               laboratory normal range.&#xD;
  &#xD;
            3. Has a history of type 1 or type 2 diabetes mellitus.&#xD;
  &#xD;
            4. Had treatment with any glucose-lowering agent(s) within 90 days before screening.&#xD;
  &#xD;
               Obesity related:&#xD;
  &#xD;
            5. Had treatment with any medication approved for the treatment of obesity or any&#xD;
               investigational agent being tested for obesity treatment within the past 6 months&#xD;
               before screening.&#xD;
  &#xD;
            6. Has been treated with/used any other medication, supplement, or device for the purpose&#xD;
               of promoting weight loss (regardless of whether they are approved or promoted for the&#xD;
               purpose of weight loss) in the 90 days prior to screening.&#xD;
  &#xD;
            7. Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist in the prior 6&#xD;
               months.&#xD;
  &#xD;
            8. Participation in an organized weight reduction program (e.g. Weight Watchers) within&#xD;
               90 days of screening.&#xD;
  &#xD;
            9. Had a previous or has a planned (during the trial period) obesity treatment with&#xD;
               surgery or a weight loss device. Note: Prior liposuction and/or abdominoplasty are not&#xD;
               exclusionary if performed &gt;2 years before screening).&#xD;
  &#xD;
           10. Has uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) outside&#xD;
               (above or below) the reference range of the central laboratory at screening or has any&#xD;
               history of Grave's disease.&#xD;
  &#xD;
           11. Obesity is induced by an endocrine disorder (e.g. Cushing's disease).&#xD;
  &#xD;
               Mental health:&#xD;
  &#xD;
           12. Has a history of major depressive disorder within 2 years before screening unless all&#xD;
               of the following criteria are met:&#xD;
  &#xD;
                 1. the depressive disorder has always been unipolar (no history of mania or&#xD;
                    hypomania)&#xD;
  &#xD;
                 2. in the opinion of the investigator, depressive symptoms have been stable and well&#xD;
                    controlled for ≥ 2 years prior to screening.&#xD;
  &#xD;
                 3. any anti-depressant drug-treatment regimens (medications and doses) have been&#xD;
                    stable for ≥6 months prior to screening.&#xD;
  &#xD;
           13. Has any history of other severe psychiatric disorder (e.g., schizophrenia, bipolar&#xD;
               disorder) that was not clearly attributable to an intercurrent event/life&#xD;
               circumstance, self-limited and fully resolved ≥1 year prior to screening.&#xD;
  &#xD;
           14. On the screening Patient Health Questionnaire-9 (PHQ-9), has an overall score ≥15 or&#xD;
               has a score &gt;0 for Question # 9 (Thoughts that you would be better off dead or of&#xD;
               hurting yourself).&#xD;
  &#xD;
           15. Has any lifetime history of suicide attempt or suicidal behavior. Note: Suicidal&#xD;
               behavior includes any acts/preparation toward making a suicide attempt whether the&#xD;
               attempt is never initiated or is initiated but interrupted by self or another person.&#xD;
  &#xD;
           16. Use of any anti-psychotic agents for any purpose within 2 years before screening.&#xD;
  &#xD;
           17. Use of prohibited classes of anti-depressant agents, for any purpose, within 6 months&#xD;
               of screening. Note: Use of allowable classes of anti-depressant agents is permitted&#xD;
               only if the anti-depressant regimen (agents and doses) has been stable for ≥6 months&#xD;
               prior to screening and is not anticipated to change during the trial period.&#xD;
  &#xD;
               General Safety:&#xD;
  &#xD;
           18. Has a recent history (within the past 3 years of the screening visit) or current&#xD;
               diagnosis of clinically significant hematological, immunological, renal, respiratory,&#xD;
               neurologic, or genitourinary abnormalities or diseases.&#xD;
  &#xD;
           19. Has a recent history (within past 3 years of the screening visit) or current diagnosis&#xD;
               of any of the following GI (gastro intestinal) related diseases: intestinal&#xD;
               obstruction, GI perforation, adhesions, Clostridium difficile colitis or have had&#xD;
               recent unexplained GI bleeding within 3 months prior to screening.&#xD;
  &#xD;
           20. Has any history of pancreatitis (acute or chronic), gastroparesis, ischemic colitis,&#xD;
               inflammatory bowel disease (IBD), or celiac disease.&#xD;
  &#xD;
           21. Has any personal or first-degree relative history of multiple endocrine neoplasia type&#xD;
               2 or medullary thyroid carcinoma.&#xD;
  &#xD;
           22. Has a screening estimated Glomerular Filtration Rate (eGFR) estimated with the&#xD;
               Modification of Diet in Renal Disease (MDRD) equation of &lt;60 ml/min/1.73 m2.&#xD;
  &#xD;
           23. Has a history of malignant neoplasms within the past 5 years prior to screening. Basal&#xD;
               and squamous cell skin cancer and any carcinoma in-situ are allowed if they have&#xD;
               received treatment and follow-up consistent with local standard of care.&#xD;
  &#xD;
           24. Has any history of cardiovascular disease including stable and unstable angina&#xD;
               pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac&#xD;
               decompensation, clinically significant arrhythmias, clinically significant conduction&#xD;
               disorders, or any history or heart failure.&#xD;
  &#xD;
           25. Has any surgery scheduled for the duration of the trial, except for minor surgical&#xD;
               procedures, in the opinion of the investigator.&#xD;
  &#xD;
           26. Has a history of human immunodeficiency virus (HIV) infection.&#xD;
  &#xD;
           27. Has any active liver disease other than non-alcoholic fatty liver disease (NAFLD), or&#xD;
               any gallbladder disease that has been active/symptomatic within 6 months of screening.&#xD;
  &#xD;
           28. Has a positive test result for hepatitis B surface antigen (Ag), hepatitis C virus&#xD;
               antibody, or HIV antibody, at the Screening Visit. Note: Participants with positive&#xD;
               hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative&#xD;
               polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid&#xD;
               is negative.&#xD;
  &#xD;
           29. Has alanine aminotransferase or aspartate aminotransferase (ALT or AST) of &gt;2.0X upper&#xD;
               limit of normal (ULN) or total bilirubin &gt;1.5X ULN at the Screening visit. Note: An&#xD;
               isolated bilirubin &gt;1.5X ULN is acceptable if bilirubin is fractionated, and direct&#xD;
               bilirubin is within the laboratory normal range.&#xD;
  &#xD;
           30. Has serum amylase or lipase &gt;1.2X the ULN at the Screening visit.&#xD;
  &#xD;
           31. Has a triglycerides value of &gt;600mg/dL at the Screening visit (if value is ≥600 mg/dL&#xD;
               and the sample was obtained in the non-fasted state, a repeat fasting determination&#xD;
               may be obtained to assess eligibility).&#xD;
  &#xD;
           32. Has a corrected QT interval to Fridericia's formula (QTcF) &gt;450 milliseconds (msec)&#xD;
               for males and &gt;470 msec for females at screening.&#xD;
  &#xD;
           33. Has a mean value for triplicate semi-recumbent systolic blood pressure &gt;160 mmHg&#xD;
               and/or diastolic blood pressure (BP) &gt;95 mmHg measured after at least 10 minutes at&#xD;
               rest at the Screening Visit.&#xD;
  &#xD;
               Note: If a subject's BP is exclusionary on the first triplicate assessment at the&#xD;
               Screening visit, they may have 1 repeat triplicate BP assessment at that visit after&#xD;
               another rest of at least 10 minutes.&#xD;
  &#xD;
               If a participant's BP is exclusionary on 2 assessments at the Screening visit, the&#xD;
               investigator can, at their discretion, adjust and/or add anti-hypertensive medications&#xD;
               and re-assess triplicate BP up to twice prior to dosing at the Randomization visit&#xD;
               (Visit 2). Anti-hypertensive regimens must be ≤2 agents that do not include verapamil.&#xD;
  &#xD;
               If a participant's BP is exclusionary at the Screening visit and the Randomization&#xD;
               visit (Visit 2), they must be excluded.&#xD;
  &#xD;
           34. Has known history or suspected abuse of alcohol or recreational drugs at Screening.&#xD;
  &#xD;
           35. Has excessive consumption of alcohol within 6 months prior to screening (&gt;14&#xD;
               drinks/week for men and &gt;7 drinks/week for women, where l drink= 5 ounces [150 mL] of&#xD;
               wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) or use of&#xD;
               soft drugs (such as marijuana or any substances containing tetrahydrocannabinol (THC)&#xD;
               or cannabidiol (CBD)) within 3 months prior to Screening, or hard drugs (such as&#xD;
               cocaine) within 6 months prior to Screening.&#xD;
  &#xD;
           36. Has a positive drug screen at Screening.&#xD;
  &#xD;
           37. Has known or suspected hypersensitivity to trial product(s) or related products.&#xD;
  &#xD;
           38. Has a history of multiple significant and/or any severe allergies (e.g., food, drug,&#xD;
               latex allergy) or has had an anaphylactic reaction or significant intolerance to&#xD;
               prescription or nonprescription drugs or food.&#xD;
  &#xD;
           39. Has previous participation in this trial. Participation is defined as signed informed&#xD;
               consent.&#xD;
  &#xD;
           40. Has participated in any clinical trial of an approved or non-approved investigational&#xD;
               medicinal product within 90 days before screening.&#xD;
  &#xD;
           41. Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4&#xD;
               weeks prior to the Screening Visit.&#xD;
  &#xD;
           42. Is a female who is pregnant, breast-feeding or intends to become pregnant during the&#xD;
               planned course of the study. Note: Participants must have a negative serum pregnancy&#xD;
               test (β-human chorionic gonadotropin (β-hCG)) performed by the central laboratory&#xD;
               prior to enrollment in the study and prior to the randomization visit.&#xD;
  &#xD;
           43. Is currently in violation of study requirements for prohibited and permissible&#xD;
               concomitant medications or is anticipated to violate these requirements during study&#xD;
               participation.&#xD;
  &#xD;
           44. Has any disorder, unwillingness or inability, not covered by any of the other&#xD;
               exclusion criteria, which in the investigator's opinion, might jeopardize the&#xD;
               subject's safety or compliance with the protocol.&#xD;
  &#xD;
           45. Is unable or unwilling to follow the study nutritional and physical activity&#xD;
               counseling and to refrain from alternative lifestyle modification strategies&#xD;
               throughout study participation.&#xD;
  &#xD;
           46. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of&#xD;
               the Sponsor or study site.&#xD;
  &#xD;
          Note: Rescreening/retesting is not permitted unless specified above.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Annemarie Vance</last_name>
      <phone>https://kallyope.com/contact/</phone>
      <email>annemarie@kallyope.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Artemis Institute for Clinical Research, LLC</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92103</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Clinical Research Atlanta</name>
        <address>
          <city>Stockbridge</city>
          <state>Georgia</state>
          <zip>30281</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Cotton O'Neil Clinical Research Center</name>
        <address>
          <city>Topeka</city>
          <state>Kansas</state>
          <zip>66606</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>L-MARC Research Center</name>
        <address>
          <city>Louisville</city>
          <state>Kentucky</state>
          <zip>40213</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Quest Research Institute</name>
        <address>
          <city>Farmington Hills</city>
          <state>Michigan</state>
          <zip>48334</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>ActivMed Practices and Research, LLC</name>
        <address>
          <city>Portsmouth</city>
          <state>New Hampshire</state>
          <zip>01844</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Rochester Clinical Research</name>
        <address>
          <city>Rochester</city>
          <state>New York</state>
          <zip>14609</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Medication Management, LLC (PharmQuest)</name>
        <address>
          <city>Greensboro</city>
          <state>North Carolina</state>
          <zip>27408</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Family Practice Center of Wadsworth, Inc dba New Venture Medical Research</name>
        <address>
          <city>Wadsworth</city>
          <state>Ohio</state>
          <zip>44281</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>AMR Norman</name>
        <address>
          <city>Norman</city>
          <state>Oklahoma</state>
          <zip>73069</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Summit Headlands LLC</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97210</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Capital Area Research, LLC</name>
        <address>
          <city>Camp Hill</city>
          <state>Pennsylvania</state>
          <zip>17011</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Spartanburg Medical Research</name>
        <address>
          <city>Spartanburg</city>
          <state>South Carolina</state>
          <zip>29303</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Headlands Research - Brownsville</name>
        <address>
          <city>Brownsville</city>
          <state>Texas</state>
          <zip>78526</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>North Hills Family Medicine/North Hills Medical Research</name>
        <address>
          <city>North Richland Hills</city>
          <state>Texas</state>
          <zip>76180</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Clinical Trials of Texas, LLC</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Washington Center for Weight Management and Research, Inc.</name>
        <address>
          <city>Arlington</city>
          <state>Virginia</state>
          <zip>22206</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Charlottesville Medical Research</name>
        <address>
          <city>Charlottesville</city>
          <state>Virginia</state>
          <zip>22911</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Health Research of Hampton Roads, Inc</name>
        <address>
          <city>Newport News</city>
          <state>Virginia</state>
          <zip>23606</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Weight Loss</mesh_term>
    </condition_browse>
    <!-- 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/NCT06019559
  org study id: K-757 P006
  nct id: NCT06019559
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a study to evaluate the safety and efficacy of K-757 alone and in combination with
        K-833 versus placebo in participants who are obese.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Percentage change from baseline in body weight (%) after 13 weeks of treatment
  time frame: 13 weeks
  measure: The proportion of participants achieving ≥5% weight loss after 13 weeks of treatment
  time frame: 13 weeks
  measure: Change from baseline in body weight (kg) after 13 weeks of treatment
  time frame: 13 weeks
  measure: Proportion of participants who experienced 1 or more treatment-emergent AEs
  time frame: 15 weeks
  measure: Proportion of participants who discontinued study medication due to an AE
  time frame: 13 weeks
  arm group label: K-757+K-833
  arm group type: Experimental
  arm group label: K-757 alone
  arm group type: Experimental
  arm group label: Placebo to K-757 and K-833
  arm group type: Experimental
  intervention type: Drug
  intervention name: K-757 and K-833
  description: Both administered orally
  arm group label: K-757+K-833
  intervention type: Drug
  intervention name: K-757 and matching placebo to K-833
  description: Both Administered orally
  arm group label: K-757 alone
  intervention type: Drug
  intervention name: Matching placebo to K-757 and matching placebo to K-833
  description: Both administered orally
  arm group label: Placebo to K-757 and K-833
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Annemarie Vance
  phone: https://kallyope.com/contact/
  email: annemarie@kallyope.com
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  country: United States
  responsible party type: Sponsor
  mesh term: Weight Loss