<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/NCT03227276</url>
  </required_header>
  <id_info>
    <org_study_id>INQ/004317</org_study_id>
    <nct_id>NCT03227276</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Litramine in 1 Year Weight Loss Study</brief_title>
  <official_title>Double-blind, Randomised, Placebo-controlled 1-year Study to Evaluate the Efficacy and Safety of Litramine in Reducing Body Weight in Overweight and Moderately Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InQpharm Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InQpharm Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of Litramine in reducing body weight in the context of an&#xD;
      energy-restricted diet in overweight and moderately obese subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">February 19, 2020</completion_date>
  <primary_completion_date type="Actual">February 19, 2020</primary_completion_date>
  <phase>N/A</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>Difference in mean body weight (kg) of overweight subjects</measure>
    <time_frame>52 weeks</time_frame>
    <description>Difference in mean body weight (kg) of overweight subjects after 52 weeks of IP intake in comparison between verum and placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in mean body weight (kg) of all subjects</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in mean body weight (kg) of obese subjects</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse effects</measure>
    <time_frame>52 weeks</time_frame>
    <description>Assessment of adverse events throughout the study</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety parameters (Lab parameters, vital signs)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Assessment of laboratory results in full blood count, clinical chemistry, blood pressure and pulse rate</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Obesity; Excess Calories</condition>
  <condition>Overweight and Obesity</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Litramine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Litramine</intervention_name>
    <description>2 tablets to be taken 3 times a day after meals</description>
    <arm_group_label>Litramine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo tablet</intervention_name>
    <description>2 tablets to be taken 3 times a day after meals</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women from 18 to 70 years old&#xD;
&#xD;
          2. Overweight (BMI 25 kg/m2 - 29.9 kg/m2) for 80% of randomized subjects and obese (BMI&#xD;
             30 kg/m2 - 34.9 kg/m2) for 20% of randomized subjects&#xD;
&#xD;
          3. Generally in good health&#xD;
&#xD;
          4. Desire to lose weight&#xD;
&#xD;
          5. Readiness and ability to complete the 1-year study, according to investigator's&#xD;
             judgement following the screening interview&#xD;
&#xD;
          6. Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)&#xD;
&#xD;
          7. Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-&#xD;
             reported change)&#xD;
&#xD;
          8. Subject's agreement to comply with study procedures, in particular:&#xD;
&#xD;
               -  to take IP as recommended&#xD;
&#xD;
               -  to avoid the use of other weight loss and/or management products and/or programs&#xD;
                  during the study&#xD;
&#xD;
               -  to adhere to diet recommendation during the study&#xD;
&#xD;
               -  to complete the subject diary and study questionnaires&#xD;
&#xD;
          9. Women of childbearing potential:&#xD;
&#xD;
               -  commitment to use contraception methods&#xD;
&#xD;
               -  negative pregnancy testing (beta human chorionic gonadotropin test in urine) at&#xD;
                  V1&#xD;
&#xD;
         10. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known allergy or hypersensitivity to the components of the investigational products or&#xD;
             source plants&#xD;
&#xD;
          2. Pathological electrocardiogram (ECG) at V1&#xD;
&#xD;
          3. History and/or presence of clinically significant condition/disorder, which per&#xD;
             investigator's judgement could interfere with the results of the study or the safety&#xD;
             of the subject, e.g.:&#xD;
&#xD;
               -  untreated or unstable thyroid gland disorder&#xD;
&#xD;
               -  untreated or unstable hypertension (regular blood pressure &gt;140/90 mm Hg)&#xD;
&#xD;
               -  acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders&#xD;
                  (e.g.&#xD;
&#xD;
             inflammatory bowel disease, coeliac disease, pancreatitis etc.)&#xD;
&#xD;
               -  diabetes mellitus type 1&#xD;
&#xD;
               -  untreated or unstable diabetes mellitus type 2&#xD;
&#xD;
               -  any other serious organ or systemic diseases that could influence the conduct&#xD;
                  and/or outcome of the study and/or could affect the tolerability of the subject&#xD;
&#xD;
          4. Significant surgery within the last 6 months prior to V1:&#xD;
&#xD;
               -  GI surgery&#xD;
&#xD;
               -  liposuction&#xD;
&#xD;
          5. History of eating disorders like bulimia, anorexia nervosa, binge-eating within the&#xD;
             last 12 months prior to V1&#xD;
&#xD;
          6. Deviation of safety laboratory parameter(s) at V1 that is:&#xD;
&#xD;
               -  clinically significant or&#xD;
&#xD;
               -  &gt;2x upper limit of normal, unless the deviation is justified by a previously&#xD;
                  known not clinically relevant condition (e.g. Gilbert's syndrome)&#xD;
&#xD;
          7. Any electronic medical implant&#xD;
&#xD;
          8. Regular medication and/or supplementation and/or treatment within the last 3 months&#xD;
             prior to V1 and during the study:&#xD;
&#xD;
               -  that could influence body weight (e.g. systemic corticosteroids)&#xD;
&#xD;
               -  that could influence gastrointestinal functions (e.g. laxatives, opioids,&#xD;
                  anticholinergics etc.) as per investigator judgement&#xD;
&#xD;
               -  for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner,&#xD;
                  satiety products, acupuncture etc.)&#xD;
&#xD;
          9. Smoking cessation within 6 months prior to V1 or during the study (regular smoking&#xD;
             during the study at the same level as prior to the study is allowed)&#xD;
&#xD;
         10. Women of child-bearing potential: pregnancy or nursing&#xD;
&#xD;
         11. History of or current abuse of drugs, alcohol or medication&#xD;
&#xD;
         12. Participation in another clinical study in the 30 days prior to V1 and during the&#xD;
             study&#xD;
&#xD;
         13. Any other reason for exclusion as per investigator's judgment, e.g. insufficient&#xD;
             compliance with study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Udo Bongartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Analyze &amp; Realize</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Analyze &amp; Realize</name>
      <address>
        <city>Berlin</city>
        <zip>10369</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Litramine</keyword>
  <keyword>Opuntia ficus-indica</keyword>
  <keyword>weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03227276
org study id: INQ/004317
nct id: NCT03227276
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy of Litramine in reducing body weight in the context of an
      energy-restricted diet in overweight and moderately obese subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference in mean body weight (kg) of overweight subjects
time frame: 52 weeks
description: Difference in mean body weight (kg) of overweight subjects after 52 weeks of IP intake in comparison between verum and placebo
measure: Difference in mean body weight (kg) of all subjects
time frame: 52 weeks
measure: Difference in mean body weight (kg) of obese subjects
time frame: 52 weeks
measure: Proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight
time frame: 52 weeks
measure: Adverse effects
time frame: 52 weeks
description: Assessment of adverse events throughout the study
measure: Safety parameters (Lab parameters, vital signs)
time frame: 52 weeks
description: Assessment of laboratory results in full blood count, clinical chemistry, blood pressure and pulse rate
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Litramine
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Litramine
description: 2 tablets to be taken 3 times a day after meals
arm group label: Litramine
intervention type: Dietary Supplement
intervention name: Placebo tablet
description: 2 tablets to be taken 3 times a day after meals
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Udo Bongartz, MD
role: Principal Investigator
affiliation: Analyze & Realize
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: Undecided