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/NCT06036784</url>
    </required_header>
    <id_info>
      <org_study_id>MBX-1P2001</org_study_id>
      <nct_id>NCT06036784</nct_id>
    </id_info>
    <brief_title>Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects and Patients With Postbariatric Hypoglycemia</brief_title>
    <official_title>Phase 1/2 Randomized, Double-Blind, Placebo-controlled, Single Ascending Dose Study in Healthy Volunteers and Multiple Ascending Dose Study in Patients With Postbariatric Hypoglycemia to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MBX 1416</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>MBX Biosciences</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ProSciento, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>MBX Biosciences</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 purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and&#xD;
        pharmacodynamics of single and multiple doses of MBX 1416 in healthy volunteers and patients&#xD;
        with postbariatric hypoglycemia.&#xD;
  &#xD;
        This study includes 2 parts. Part A involves a single dose of MBX 1416 or placebo taken as a&#xD;
        subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a&#xD;
        subcutaneous injection (SC).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">October 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 17, 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Double Blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)</measure>
      <time_frame>Baseline through Day 29 (Part A) or Day 45 (Part B)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Plasma Concentration (Cmax)</measure>
      <time_frame>Baseline through Day 29 (Part A) or Day 45 (Part B)</time_frame>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Healthy</condition>
    <condition>Postbariatric Hypoglycemia</condition>
    <arm_group>
      <arm_group_label>MBX 1416 (Part A)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single ascending subcutaneous (SC) doses</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MBX 1416 (Part B)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Repeated ascending subcutaneous (SC) doses</description>
    </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>MBX 1416 (Part A)</intervention_name>
      <description>Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30 mg,100mg, 200mg</description>
      <arm_group_label>MBX 1416 (Part A)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>MBX 1416 (Part B)</intervention_name>
      <description>Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg</description>
      <arm_group_label>MBX 1416 (Part B)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Single dose or repeated subcutaneous (SC) dose of placebo.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Part A Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy men and women, between 18 and 65 years of age inclusive.&#xD;
  &#xD;
            2. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2 and stable body weight by history for ≥ 3&#xD;
               months.&#xD;
  &#xD;
            3. Fasting plasma glucose &lt; 100 mg/dL and HbA1c &lt; 5.7%&#xD;
  &#xD;
          Part A Exclusion Criteria:&#xD;
  &#xD;
            1. Use of weight-lowering pharmacotherapy or participation in a clinical weight control&#xD;
               study.&#xD;
  &#xD;
            2. Subjects with a prior history of any serious adverse reaction, hypersensitivity or&#xD;
               angioedema to GLP-1 receptor agonists.&#xD;
  &#xD;
            3. Presence of any clinically significant physical exam, ECG, or laboratory findings at&#xD;
               screening.&#xD;
  &#xD;
          Part B Inclusion Criteria:&#xD;
  &#xD;
            1. Female and male adults, ages ≥ 18 and ≤ 65 years.&#xD;
  &#xD;
            2. BMI ≥ 25 kg/m2 to ≤ 35.0 kg/m2 and stable body weight by history for ≥ 3 months.&#xD;
  &#xD;
            3. Fasting plasma glucose &lt; 100 mg/dL and HbA1c &lt; 5.7%.&#xD;
  &#xD;
            4. Bariatric surgery (i.e., Roux-en-Y Gastric Bypass [RYGB]), or upper-gastrointestinal&#xD;
               surgery (i.e., only vertical sleeve gastrectomy [VSG]) at least 6 months before&#xD;
               screening.&#xD;
  &#xD;
            5. Patients with PBH identified by the following criteria: (Whipple's triad) (Salehi et&#xD;
               al., 2018)&#xD;
  &#xD;
                 1. experiencing post-prandial hypoglycemia occurring 1-3 hours after meals AND&#xD;
  &#xD;
                 2. with documented hypoglycemia at the time of neuroglycopenic symptoms AND&#xD;
  &#xD;
                 3. with resolution of symptoms after treatment to raise glucose.&#xD;
  &#xD;
            6. Patients must be able and willing to adhere to PBH dietary recommendations.&#xD;
  &#xD;
          Part B Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with confirmed diabetes type 1 or type 2.&#xD;
  &#xD;
            2. Patients with dumping syndrome.&#xD;
  &#xD;
            3. Other reasons for hypoglycemia than PBH.&#xD;
  &#xD;
            4. Patients with a prior history of hypersensitivity or angioedema to GLP-1 receptor&#xD;
               agonists, study drug or drug components.&#xD;
  &#xD;
            5. Current diagnosis of acute or chronic pancreatitis or factors for pancreatitis, such&#xD;
               as cholelithiasis (without cholecystectomy) or alcohol abuse.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Victoria Mirza, MD, MPH</last_name>
      <phone>619-755-6473</phone>
      <email>victoria.mirza@prosciento.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mary Jane Geiger, MD, PhD</last_name>
      <email>maryjane@mbxbio.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 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 14, 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>Hypoglycemia</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/NCT06036784
  org study id: MBX-1P2001
  nct id: NCT06036784
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and
        pharmacodynamics of single and multiple doses of MBX 1416 in healthy volunteers and patients
        with postbariatric hypoglycemia.
  
        This study includes 2 parts. Part A involves a single dose of MBX 1416 or placebo taken as a
        subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a
        subcutaneous injection (SC).
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  masking description: Double Blind
  measure: Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)
  time frame: Baseline through Day 29 (Part A) or Day 45 (Part B)
  measure: Maximum Plasma Concentration (Cmax)
  time frame: Baseline through Day 29 (Part A) or Day 45 (Part B)
  arm group label: MBX 1416 (Part A)
  arm group type: Experimental
  description: Single ascending subcutaneous (SC) doses
  arm group label: MBX 1416 (Part B)
  arm group type: Experimental
  description: Repeated ascending subcutaneous (SC) doses
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: MBX 1416 (Part A)
  description: Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30 mg,100mg, 200mg
  arm group label: MBX 1416 (Part A)
  intervention type: Drug
  intervention name: MBX 1416 (Part B)
  description: Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg
  arm group label: MBX 1416 (Part B)
  intervention type: Drug
  intervention name: Placebo
  description: Single dose or repeated subcutaneous (SC) dose of placebo.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Victoria Mirza, MD, MPH
  phone: 619-755-6473
  email: victoria.mirza@prosciento.com
  last name: Mary Jane Geiger, MD, PhD
  email: maryjane@mbxbio.com
  responsible party type: Sponsor
  mesh term: Hypoglycemia