<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/NCT02250105</url>
  </required_header>
  <id_info>
    <org_study_id>ARI-3037MO-004</org_study_id>
    <nct_id>NCT02250105</nct_id>
  </id_info>
  <brief_title>Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arisaph Pharmaceuticals Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baim Institute for Clinical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Arisaph Pharmaceuticals Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the efficacy and safety of ARI-3037MO 3g BID compared to placebo in&#xD;
      reducing triglyceride (TG) levels of subjects with severe (≥500 mg/dL and &lt;2,000 mg/dL)&#xD;
      hypertriglyceridemia. Eligible patients will enter a 4- to 6-week lead-in period (6-week&#xD;
      washout for subjects on non-statin lipid-lowering therapy [subjects may remain on statins&#xD;
      during this period], 4 weeks for patients on statins only or not receiving any type of&#xD;
      lipid-lowering therapy), followed by qualifying fasting TG measurements at visits 2 and 3, at&#xD;
      least 7 days apart. If the baseline TG value is &gt; 500 mg/dL and &lt; 2,000 mg/dL, the qualified&#xD;
      subjects will be randomized at visit 4 and enter the double-blind, 12-week efficacy and&#xD;
      safety assessment phase. End-of-study lipid levels will be assessed on visits 6 and 7 (weeks&#xD;
      11 and 12 average). A final closeout and safety assessment visit will be done 14 weeks post&#xD;
      randomization&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Change in Triglyceride levels</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in LDL cholesterol</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL cholesterol</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Hypertriglyceridemia</condition>
  <arm_group>
    <arm_group_label>ARI-3037MO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ARI-3037MO 3g bid orally for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo 3g bid orally for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ARI-3037MO</intervention_name>
    <description>Lipid lowering</description>
    <arm_group_label>ARI-3037MO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Inactive</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria 1. Age ≥ 18 years. 2. Subjects willing to comply with lifestyle&#xD;
        intervention modifications (diet and exercise) 3. TG levels: At randomization, mean level &gt;&#xD;
        500 mg/dL and &lt; 2,000 mg/dL. 4. Understands the trial requirements and the treatment&#xD;
        procedures, is willing to comply with all protocol-required follow-up evaluation and&#xD;
        provides written informed consent.&#xD;
&#xD;
        5. Patients already taking statin therapy must be on a stable dose, defined as no changes&#xD;
        in the dose of statin in the 3 months prior to enrollment, and must be willing and able to&#xD;
        remain on that dose for the duration of the study.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria 1. History of pancreatitis. 2. Body mass index &gt; 45 kg/m2. 3. Weight&#xD;
        change ≥ 3 kg during the lead-in period. 4. Contraindication to niacin treatment (prior&#xD;
        flushing is not regarded as a contraindication to niacin treatment).&#xD;
&#xD;
        5. Uncontrolled diabetes, defined as HbA1C &gt; 10.5. 6. Subjects who would benefit from&#xD;
        statin treatment per clinical guidelines but who are not taking statins are excluded.&#xD;
        However, these patients may be included only if the subject's primary care physician&#xD;
        confirms the decision not to treat according to guidelines and its reason (e.g. statin&#xD;
        intolerant subjects, subject refusal, etc.), and it has been agreed upon by the subject,&#xD;
        the site investigator, and the primary care physician, after discussion of the potential&#xD;
        risks of non-treatment with statins..&#xD;
&#xD;
        7. History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary&#xD;
        vascularization within 6 months before screening.&#xD;
&#xD;
        8. Thyroid-stimulating hormone ≥ 1.5 times the ULN. 9. Clinical evidence of hypothyroidism&#xD;
        or thyroid hormonal therapy that has not been stable for ≥ 6 weeks before screening.&#xD;
&#xD;
        10. Creatine kinase concentration ≥ 3 times the ULN. 11. Known, active liver disease,&#xD;
        including but not limited to:&#xD;
&#xD;
          1. Confirmed alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline&#xD;
             phosphatase, or bilirubin ≥ 2 times the ULN.&#xD;
&#xD;
          2. Hepatitis C (anti-hepatitis C virus IgG +).&#xD;
&#xD;
          3. Hepatitis B (hepatitis B surface [HBs] antigen +, anti hepatitis B core [HBc] antigen&#xD;
             immunoglobulin M [IgM]+).&#xD;
&#xD;
          4. Hepatitis A (anti HBa IgM+). 12. Blood donation of ≥ 1 pint (0.5 L) within 30 days&#xD;
             before screening or plasma donation within 7 days before screening.&#xD;
&#xD;
             13. History of symptomatic gallstone disease unless treated with cholecystectomy.&#xD;
&#xD;
             14. Known nephrotic syndrome or ≥ 3 g/day proteinuria. 15. Past organ transplant or on&#xD;
             a waiting list for an organ transplant. 16. Currently receiving or scheduled to&#xD;
             receive chemotherapy within 30 days before or after enrollment.&#xD;
&#xD;
             17. Other serious medical illness (e.g., cancer, congestive heart failure) with&#xD;
             estimated life expectancy of less than 12 months.&#xD;
&#xD;
             18. Problems with substance abuse, which, in the opinion of the investigator, might&#xD;
             affect study compliance.&#xD;
&#xD;
             19. Planned procedure that may cause non-compliance with the protocol or confound data&#xD;
             interpretation.&#xD;
&#xD;
             20. Current participation in another investigational drug or device clinical trial&#xD;
             that has not reached its primary endpoint.&#xD;
&#xD;
             21. Women who intend to become pregnant within 12 months after enrollment. Women of&#xD;
             child-bearing potential who are sexually active must agree to use a reliable method of&#xD;
             contraception from the time of screening through 12 months after enrollment.&#xD;
&#xD;
             22. Women who are pregnant or nursing. 23. Estimated glomerular filtration rate (eGFR)&#xD;
             &lt; 60 mL/min/1.73&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orange County Research Center</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisville Metabolic and Atherosclerosis Research Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Research Associates</name>
      <address>
        <city>Auburn</city>
        <state>Maine</state>
        <zip>04210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sterling Clinical Research Inc</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical Research inc</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>August 5, 2016</last_update_submitted>
  <last_update_submitted_qc>August 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2016</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>Hypertriglyceridemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02250105
org study id: ARI-3037MO-004
nct id: NCT02250105
lead sponsor: 
collaborator: 
has dmc: No
This study is to evaluate the efficacy and safety of ARI-3037MO 3g BID compared to placebo in
      reducing triglyceride (TG) levels of subjects with severe (≥500 mg/dL and <2,000 mg/dL)
      hypertriglyceridemia. Eligible patients will enter a 4- to 6-week lead-in period (6-week
      washout for subjects on non-statin lipid-lowering therapy [subjects may remain on statins
      during this period], 4 weeks for patients on statins only or not receiving any type of
      lipid-lowering therapy), followed by qualifying fasting TG measurements at visits 2 and 3, at
      least 7 days apart. If the baseline TG value is > 500 mg/dL and < 2,000 mg/dL, the qualified
      subjects will be randomized at visit 4 and enter the double-blind, 12-week efficacy and
      safety assessment phase. End-of-study lipid levels will be assessed on visits 6 and 7 (weeks
      11 and 12 average). A final closeout and safety assessment visit will be done 14 weeks post
      randomization
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Triglyceride levels
time frame: 12 weeks
measure: Change in LDL cholesterol
time frame: 12 weeks
measure: Change in HDL cholesterol
time frame: 12 weeks
arm group label: ARI-3037MO
arm group type: Active Comparator
description: ARI-3037MO 3g bid orally for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo 3g bid orally for 12 weeks
intervention type: Drug
intervention name: ARI-3037MO
description: Lipid lowering
arm group label: ARI-3037MO
intervention type: Drug
intervention name: Placebo
description: Inactive
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertriglyceridemia