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/NCT06005597</url>
    </required_header>
    <id_info>
      <org_study_id>OBEZ-301</org_study_id>
      <nct_id>NCT06005597</nct_id>
    </id_info>
    <brief_title>Study of Obicetrapib &amp; Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies</brief_title>
    <acronym>TANDEM</acronym>
    <official_title>A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NewAmsterdam Pharma</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NewAmsterdam Pharma</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 study is a placebo-controlled, double-blind, randomized, phase 3 study in participants&#xD;
        with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular&#xD;
        disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and&#xD;
        tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to&#xD;
        diet and maximally tolerated lipid-lowering therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be a placebo-controlled, double-blind, randomized, phase 3 study in&#xD;
        participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic&#xD;
        cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy,&#xD;
        safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated&#xD;
        lipid-lowering therapy. The screening period for this study will take up to 14 days.&#xD;
        Afterwards patients will be randomized 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed&#xD;
        dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment&#xD;
        period. After the treatment period, patients will have an end of study follow-up visit.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>Phase 3</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>Placebo-controlled, double blind, randomized</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>placebo tablets made to resemble active; placebo capsule made to resemble active</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Effect of combination therapy compared to placebo on LDL-C</measure>
      <time_frame>84-Days</time_frame>
      <description>Percent Change in LDL-C</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effect of combination therapy compared to ezetimibe 10 mg monotherapy on LDL-C</measure>
      <time_frame>84-Days</time_frame>
      <description>Percent Change in LDL-C</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effect of combination therapy compared to obicetrapib 10 mg monotherapy on LDL-C</measure>
      <time_frame>84-Days</time_frame>
      <description>Percent Change in LDL-C</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effect of combination therapy compared to placebo on non-HDL-C</measure>
      <time_frame>84-Days</time_frame>
      <description>Percent Change in non-HDL-C</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of combination therapy compared compared to ezetimibe 10 mg monotherapy on non-HDL-C</measure>
      <time_frame>84-Days</time_frame>
      <description>Percent Change in non-HDL-C</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of combination therapy compared to obicetrapib 10 mg monotherapy on non-HDL-C</measure>
      <time_frame>84-Days</time_frame>
      <description>Percent Change in non-HDL-C</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of combination therapy compared to placebo on Apolipoprotein B (ApoB)</measure>
      <time_frame>84-Days</time_frame>
      <description>Percent Change in ApoB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of combination therapy compared to ezetimibe 10 mg monotherapy on ApoB</measure>
      <time_frame>84-Days</time_frame>
      <description>Percent Change in ApoB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of combination therapy compared to obicetrapib 10 mg monotherapy on ApoB</measure>
      <time_frame>84-Days</time_frame>
      <description>Percent Change in ApoB</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Dyslipidemias</condition>
    <condition>Hypercholesterolemia</condition>
    <condition>Familial Hypercholesterolemia</condition>
    <condition>ASCVD</condition>
    <condition>High Cholesterol</condition>
    <arm_group>
      <arm_group_label>Combination Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Monotherapy obicetrapib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>once-daily obicetrapib 10 mg, placebo tablet, placebo capsule</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Monotherapy ezetimibe</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>once-daily ezetimibe 10 mg capsule, 2 placebo tablets</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>once-daily placebo tablets (2), placebo capsule</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Combination Therapy</intervention_name>
      <description>tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination</description>
      <arm_group_label>Combination Therapy</arm_group_label>
      <other_name>Cholesteryl ester transfer protein (CETP) inhibitor</other_name>
      <other_name>obicetrapib</other_name>
      <other_name>ezetimibe</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Monotherapy obicetrapib</intervention_name>
      <description>tablet; 10mg obicetrapib</description>
      <arm_group_label>Monotherapy obicetrapib</arm_group_label>
      <other_name>CETP inhibitor</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Monotherapy ezetimibe</intervention_name>
      <description>capsule; 10mg ezetimibe</description>
      <arm_group_label>Monotherapy ezetimibe</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Combination Therapy placebo</intervention_name>
      <description>tablet; no active ingredient</description>
      <arm_group_label>Monotherapy ezetimibe</arm_group_label>
      <arm_group_label>Monotherapy obicetrapib</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Obicetrapib Placebo</intervention_name>
      <description>tablet; no active ingredient</description>
      <arm_group_label>Combination Therapy</arm_group_label>
      <arm_group_label>Monotherapy ezetimibe</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ezetimibe Placebo</intervention_name>
      <description>capsule; no active ingredient</description>
      <arm_group_label>Combination Therapy</arm_group_label>
      <arm_group_label>Monotherapy obicetrapib</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors&#xD;
  &#xD;
            -  On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle&#xD;
               modifications&#xD;
  &#xD;
            -  LDL-C ≥ 70 mg/dL or HDL-C ≥ 100 mg/dL&#xD;
  &#xD;
            -  Triglycerides &lt; 500&#xD;
  &#xD;
            -  Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of New York Heart Association (NYHA) class III or IV heart failure of left&#xD;
               ventricular ejection fraction &lt;30%&#xD;
  &#xD;
            -  Hospitalized for heart failure within the last 5 years&#xD;
  &#xD;
            -  Myocardial infarction, stroke, non-elective coronary revascularization or&#xD;
               hospitalization for unstable angina or chest pain in the last 3 months&#xD;
  &#xD;
            -  Uncontrolled severe hypertension&#xD;
  &#xD;
            -  Diagnosis of homozygous FH&#xD;
  &#xD;
            -  Liver disease&#xD;
  &#xD;
            -  HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL&#xD;
  &#xD;
            -  Thyroid-stimulating hormone &gt;1.5 x upper limit of normal (ULN)&#xD;
  &#xD;
            -  History of malignancy&#xD;
  &#xD;
            -  Creatinine kinase (CK) &gt;3 X ULN&#xD;
  &#xD;
            -  Alcohol abuse&#xD;
  &#xD;
            -  Treatment with investigational product&#xD;
  &#xD;
            -  Treatment with gemfibrozil or ezetimibe&#xD;
  &#xD;
            -  Previous participation in a trial evaluating obicetrapib&#xD;
  &#xD;
            -  Known allergy to study drugs, placebo or excipients in study drugs of placebo&#xD;
  &#xD;
            -  Other condition that would interfere with the conduct of the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marc Ditmarsch, MD</last_name>
      <role>Study Director</role>
      <affiliation>NewAmsterdam Pharma</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kirsten Bowman</last_name>
      <phone>1-513-205-1109</phone>
      <email>k.bowman@medpace.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>obicetrapib</keyword>
    <keyword>statin</keyword>
    <keyword>LDL-C</keyword>
    <keyword>cholesterol</keyword>
    <keyword>atherosclerosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperlipoproteinemia Type II</mesh_term>
      <mesh_term>Hypercholesterolemia</mesh_term>
      <mesh_term>Dyslipidemias</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ezetimibe</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/NCT06005597
  org study id: OBEZ-301
  nct id: NCT06005597
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants
        with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular
        disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and
        tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to
        diet and maximally tolerated lipid-lowering therapy.
  This study will be a placebo-controlled, double-blind, randomized, phase 3 study in
        participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic
        cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy,
        safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated
        lipid-lowering therapy. The screening period for this study will take up to 14 days.
        Afterwards patients will be randomized 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed
        dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment
        period. After the treatment period, patients will have an end of study follow-up visit.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Placebo-controlled, double blind, randomized
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: placebo tablets made to resemble active; placebo capsule made to resemble active
  measure: Effect of combination therapy compared to placebo on LDL-C
  time frame: 84-Days
  description: Percent Change in LDL-C
  measure: Effect of combination therapy compared to ezetimibe 10 mg monotherapy on LDL-C
  time frame: 84-Days
  description: Percent Change in LDL-C
  measure: Effect of combination therapy compared to obicetrapib 10 mg monotherapy on LDL-C
  time frame: 84-Days
  description: Percent Change in LDL-C
  measure: Effect of combination therapy compared to placebo on non-HDL-C
  time frame: 84-Days
  description: Percent Change in non-HDL-C
  measure: Effect of combination therapy compared compared to ezetimibe 10 mg monotherapy on non-HDL-C
  time frame: 84-Days
  description: Percent Change in non-HDL-C
  measure: Effect of combination therapy compared to obicetrapib 10 mg monotherapy on non-HDL-C
  time frame: 84-Days
  description: Percent Change in non-HDL-C
  measure: Effect of combination therapy compared to placebo on Apolipoprotein B (ApoB)
  time frame: 84-Days
  description: Percent Change in ApoB
  measure: Effect of combination therapy compared to ezetimibe 10 mg monotherapy on ApoB
  time frame: 84-Days
  description: Percent Change in ApoB
  measure: Effect of combination therapy compared to obicetrapib 10 mg monotherapy on ApoB
  time frame: 84-Days
  description: Percent Change in ApoB
  arm group label: Combination Therapy
  arm group type: Experimental
  description: once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
  arm group label: Monotherapy obicetrapib
  arm group type: Experimental
  description: once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
  arm group label: Monotherapy ezetimibe
  arm group type: Active Comparator
  description: once-daily ezetimibe 10 mg capsule, 2 placebo tablets
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: once-daily placebo tablets (2), placebo capsule
  intervention type: Combination Product
  intervention name: Combination Therapy
  description: tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
  arm group label: Combination Therapy
  other name: Cholesteryl ester transfer protein (CETP) inhibitor
  other name: obicetrapib
  other name: ezetimibe
  intervention type: Drug
  intervention name: Monotherapy obicetrapib
  description: tablet; 10mg obicetrapib
  arm group label: Monotherapy obicetrapib
  other name: CETP inhibitor
  intervention type: Drug
  intervention name: Monotherapy ezetimibe
  description: capsule; 10mg ezetimibe
  arm group label: Monotherapy ezetimibe
  intervention type: Other
  intervention name: Combination Therapy placebo
  description: tablet; no active ingredient
  arm group label: Monotherapy ezetimibe
  arm group label: Monotherapy obicetrapib
  arm group label: Placebo
  intervention type: Other
  intervention name: Obicetrapib Placebo
  description: tablet; no active ingredient
  arm group label: Combination Therapy
  arm group label: Monotherapy ezetimibe
  arm group label: Placebo
  intervention type: Other
  intervention name: Ezetimibe Placebo
  description: capsule; no active ingredient
  arm group label: Combination Therapy
  arm group label: Monotherapy obicetrapib
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marc Ditmarsch, MD
  role: Study Director
  affiliation: NewAmsterdam Pharma
  last name: Kirsten Bowman
  phone: 1-513-205-1109
  email: k.bowman@medpace.com
  responsible party type: Sponsor
  mesh term: Hyperlipoproteinemia Type II
  mesh term: Hypercholesterolemia
  mesh term: Dyslipidemias
  mesh term: Ezetimibe
  sharing ipd: No