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/NCT05972278</url>
    </required_header>
    <id_info>
      <org_study_id>TA-8995-204</org_study_id>
      <secondary_id>The NICE Study</secondary_id>
      <nct_id>NCT05972278</nct_id>
    </id_info>
    <brief_title>Investigating the Effect of Obicetrapib on Lipoprotein Metabolism</brief_title>
    <official_title>A Placebo-Controlled, Phase 1 Study to Investigate the Effect of Obicetrapib on Lipoprotein Metabolism in Statin-Treated Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NewAmsterdam Pharma</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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>
        To determine the treatment effect with obicetrapib (10 mg) added to background statin therapy&#xD;
        on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density&#xD;
        lipoprotein (LDL).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study population will comprise 20 adults, 18 to 75 years of age, who are either&#xD;
        normolipidemic or dyslipidemic and in good health otherwise based on medical history,&#xD;
        physical examination, vital signs and laboratory safety tests. Subjects will have plasma&#xD;
        triglyceride level ≤ 400 mg/dL and LDL-cholesterol (LDL-C) levels ≥ 70 mg/dL and ≤ 200 mg/dL&#xD;
        at Screening Visit and on stable Atorvastatin or Rosuvastatin for a minimum of 4 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>This is a phase 1, single-site, randomized, double-blind, placebo-controlled, 2 period, fixed-sequence, pharmacodynamic study in normalipidemic or dyslipidemic subjects receiving background atorvastatin or rosuvastatin. Eligible subjects must meet all the inclusion and exclusion criteria while being on a background statin. At the Screening Visit (Visit 1A), subjects who are statin naïve or taking a different statin or another lipid lowering drug will initiate (if statin naïve), or switch to rosuvastatin 10 mg daily for a minimum of 4 weeks, at which point, LDL-C levels will be measured to determine eligibility (Statin Optimization Visit 1B). Subjects who are currently taking either atorvastatin or rosuvastatin (at any dose) at Visit 1A, can be enrolled immediately and proceed to the Baseline Kinetics Study (Visit 2A) within 1-4 weeks if all other eligibility criteria are met.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Double-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment with obicetrapib (10 mg) added to background statin therapy on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).</measure>
      <time_frame>8-12 week</time_frame>
      <description>The mean differences (obicetrapib with statin - placebo with statin) in the LDL apoB100 FCR using the baseline measure of each variable as a covariant.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Treatment with obicetrapib (10 mg) added to background statin therapy on the production rate (PR) of apolipoprotein(a), or apo(a), in Lp(a).</measure>
      <time_frame>8-12 weeks</time_frame>
      <description>The mean differences (obicetrapib with statin - placebo with statin) in the apo(a) in Lp(a) production rate using the baseline measure of each variable as a covariate.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Treatment with obicetrapib (10 mg) added to background statin therapy on the FCR of total apolipoprotein (apo) B100 in plasma.</measure>
      <time_frame>8-12 weeks</time_frame>
      <description>The mean difference (obicetrapib with statin - placebo with statin) on the FCR of total apolipoprotein (apo) B100 in plasma using the baseline measure of each variable as a covariate.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Hyperlipidemias</condition>
    <condition>Dyslipidemias</condition>
    <arm_group>
      <arm_group_label>Obicetrapib placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>identical matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Obicetrapib 10 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 mg tablets</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Obicetrapib</intervention_name>
      <description>1 tablet daily</description>
      <arm_group_label>Obicetrapib 10 mg</arm_group_label>
      <arm_group_label>Obicetrapib placebo</arm_group_label>
      <other_name>tablets</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Willing to sign the Informed Consent Form.&#xD;
  &#xD;
            -  Subject is a male or female between 18 to 75 years of age.&#xD;
  &#xD;
            -  Females may be enrolled if they are not pregnant, are not breastfeeding, and do not&#xD;
               plan on becoming pregnant during the study.&#xD;
  &#xD;
            -  Subject has a stable weight (± 3 kg) for at least 6 weeks prior to screening.&#xD;
  &#xD;
            -  Subject has a body mass index (BMI) of &gt; 18.5 and ≤ 40 kg/m2 at the pre-study&#xD;
               (Screening) visit. BMI is calculated by taking the subject's weight in kg and dividing&#xD;
               it by the subject's height in meters, squared.&#xD;
  &#xD;
            -  Subject is judged to be in good health by the Study PI based on medical history,&#xD;
               physical examination, vital sign measurements, electrocardiogram (ECG) assessments and&#xD;
               laboratory safety tests performed at the Screening (Visit 1A) and/or prior to&#xD;
               administration of the initial dose of study drug.&#xD;
  &#xD;
            -  Subject has fasting plasma triglyceride level ≤ 400 mg/dL, at Screening Visit 1A and&#xD;
               is on atorvastatin or rosuvastatin for a minimum of 4 weeks, or at the Statin&#xD;
               Optimization Visit 1B if subject has switched to, or initiated, 10 mg daily&#xD;
               rosuvastatin for a minimum of 4 weeks.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject is statin-naïve and has an LDL-C &lt; 110 mg/dL at Screening (Visit 1A).&#xD;
  &#xD;
            -  Subject has a current or any previous history of New York Heart Association (NYHA)&#xD;
               class III or IV heart failure or left ventricular ejection fraction &lt; 30%.&#xD;
  &#xD;
            -  Subject has uncontrolled hypertension defined as either systolic blood pressure ≥ 180&#xD;
               mmHg or diastolic blood pressure ≥ 100 mmHg prior to the Baseline visit, taken as the&#xD;
               average of triplicate measurements. One triplicate retest will be allowed during the&#xD;
               same visit, at which point if the retest result is no longer exclusionary, the subject&#xD;
               may be randomized.&#xD;
  &#xD;
            -  Subject has an eGFR &lt; 45 mL/min/1.73m2 at the Screening visit or history of end-stage&#xD;
               renal disease (ESRD).&#xD;
  &#xD;
            -  Subject has active liver disease, defined as any known current infectious, neoplastic,&#xD;
               or metabolic pathology of the liver; unexplained elevations in alanine&#xD;
               aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 3 x upper limit of normal&#xD;
               (ULN); or total bilirubin &gt; 2 x ULN at the and/or Screening visit.&#xD;
  &#xD;
            -  Subject has a history of stroke, chronic seizures, or major neurological disorder.&#xD;
  &#xD;
            -  For subjects on thyroid hormone replacement treatment at the time of screening, there&#xD;
               is no lower thyroid stimulating hormone (TSH) threshold for entry. The subject must&#xD;
               have been on a stable dose of thyroid hormone therapy for ≥ 6 weeks prior to the&#xD;
               screening. If TSH levels are undetectable and the subject requires a change in thyroid&#xD;
               hormone therapy or this represents a new diagnosis, then the subject will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dan Radar, MD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Dyslipidemias</mesh_term>
      <mesh_term>Hyperlipidemias</mesh_term>
    </condition_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/NCT05972278
  org study id: TA-8995-204
  secondary id: The NICE Study
  nct id: NCT05972278
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  To determine the treatment effect with obicetrapib (10 mg) added to background statin therapy
        on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density
        lipoprotein (LDL).
  The study population will comprise 20 adults, 18 to 75 years of age, who are either
        normolipidemic or dyslipidemic and in good health otherwise based on medical history,
        physical examination, vital signs and laboratory safety tests. Subjects will have plasma
        triglyceride level ≤ 400 mg/dL and LDL-cholesterol (LDL-C) levels ≥ 70 mg/dL and ≤ 200 mg/dL
        at Screening Visit and on stable Atorvastatin or Rosuvastatin for a minimum of 4 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a phase 1, single-site, randomized, double-blind, placebo-controlled, 2 period, fixed-sequence, pharmacodynamic study in normalipidemic or dyslipidemic subjects receiving background atorvastatin or rosuvastatin. Eligible subjects must meet all the inclusion and exclusion criteria while being on a background statin. At the Screening Visit (Visit 1A), subjects who are statin naïve or taking a different statin or another lipid lowering drug will initiate (if statin naïve), or switch to rosuvastatin 10 mg daily for a minimum of 4 weeks, at which point, LDL-C levels will be measured to determine eligibility (Statin Optimization Visit 1B). Subjects who are currently taking either atorvastatin or rosuvastatin (at any dose) at Visit 1A, can be enrolled immediately and proceed to the Baseline Kinetics Study (Visit 2A) within 1-4 weeks if all other eligibility criteria are met.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Double-blind
  measure: Treatment with obicetrapib (10 mg) added to background statin therapy on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).
  time frame: 8-12 week
  description: The mean differences (obicetrapib with statin - placebo with statin) in the LDL apoB100 FCR using the baseline measure of each variable as a covariant.
  measure: Treatment with obicetrapib (10 mg) added to background statin therapy on the production rate (PR) of apolipoprotein(a), or apo(a), in Lp(a).
  time frame: 8-12 weeks
  description: The mean differences (obicetrapib with statin - placebo with statin) in the apo(a) in Lp(a) production rate using the baseline measure of each variable as a covariate.
  measure: Treatment with obicetrapib (10 mg) added to background statin therapy on the FCR of total apolipoprotein (apo) B100 in plasma.
  time frame: 8-12 weeks
  description: The mean difference (obicetrapib with statin - placebo with statin) on the FCR of total apolipoprotein (apo) B100 in plasma using the baseline measure of each variable as a covariate.
  arm group label: Obicetrapib placebo
  arm group type: Placebo Comparator
  description: identical matching placebo
  arm group label: Obicetrapib 10 mg
  arm group type: Experimental
  description: 10 mg tablets
  intervention type: Drug
  intervention name: Obicetrapib
  description: 1 tablet daily
  arm group label: Obicetrapib 10 mg
  arm group label: Obicetrapib placebo
  other name: tablets
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dan Radar, MD
  role: Study Chair
  affiliation: University of Pennsylvania
  responsible party type: Sponsor
  mesh term: Dyslipidemias
  mesh term: Hyperlipidemias
  sharing ipd: No