<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/NCT03008954</url>
  </required_header>
  <id_info>
    <org_study_id>Attiva-03</org_study_id>
    <nct_id>NCT03008954</nct_id>
  </id_info>
  <brief_title>Effect of GSP3 on Body Weight in Overweight and Obese Subjects</brief_title>
  <acronym>FLOW</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GSP3 on Body Weight in Overweight and Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gelesis, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gelesis, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The FLOW (First Loss Of Weight) study is designed to assess the effects of repeated&#xD;
      administration of GSP3, an investigational product, on body weight. It is a multicenter,&#xD;
      randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. FLOW is being&#xD;
      conducted in 5 medical centers in Italy, Czech Republic, and Denmark, and will randomize 123&#xD;
      overweight and obese adult males and females to receive either placebo, GSP3 (2.25g), or GSP3&#xD;
      (3.75g) in addition to a hypocaloric diet (-600 kcal/day) for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)</time_frame>
    <description>Change from baseline in kilograms and percent (%) weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight responders</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from baseline in body weight of at least 5%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)</time_frame>
    <description>Change from baseline in waist circumference (centimeters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat mass</measure>
    <time_frame>Measured at weeks 0 and 13</time_frame>
    <description>Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bone-free fat mass</measure>
    <time_frame>Measured at weeks 0 and 13</time_frame>
    <description>Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in appetite (hunger, satiety, and fullness)</measure>
    <time_frame>Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)</time_frame>
    <description>Assessed by self-administered Visual Analog Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food intake</measure>
    <time_frame>Measured at weeks 0 and 12</time_frame>
    <description>Assessed by 24 hr dietary recall</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in plasma glucose</measure>
    <time_frame>Measured at baseline and week 13</time_frame>
    <description>Change from baseline in millimoles per liter (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in plasma glucose status (normal, impaired, diabetic)</measure>
    <time_frame>Measured at weeks 0 and 13</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum insulin</measure>
    <time_frame>Measured at weeks 0 and 13</time_frame>
    <description>Change from baseline in miliunits per liter (mU/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in insulin resistance</measure>
    <time_frame>Measured at weeks 0 and 13</time_frame>
    <description>Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in glycosylated hemoglobin (HbA1c)</measure>
    <time_frame>Measured at weeks 0 and 13</time_frame>
    <description>Measured in percentage (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides</measure>
    <time_frame>Measured at weeks 0 and 13</time_frame>
    <description>measured in mg/dL</description>
  </other_outcome>
  <other_outcome>
    <measure>Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP)</measure>
    <time_frame>Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)</time_frame>
    <description>Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure</description>
  </other_outcome>
  <other_outcome>
    <measure>All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms</measure>
    <time_frame>Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)</time_frame>
    <description>Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum sodium</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline in millimoles per liter (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum potassium</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum coloride</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum calcium</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum magnesium</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum phosphorus</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum glucose</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in blood urea nitrogen (BUN)</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum creatinine</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline in micromoles per liter (umol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum uric acid</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (umol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in total bilirubin</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (umol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in alanine aminotransferase (ALT)</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline in international units per liter (IU/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in aspartate transaminase (AST)</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (IU/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in gamma-glutamyl transpeptidase (GGT)</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (IU/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in alkaline phosphatase (ALP)</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (IU/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum total protein</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline in grams per liter (g/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum albumin</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow up (week 14)</time_frame>
    <description>Change from baseline (g/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in hematocrit</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow-up (week 14)</time_frame>
    <description>Change from baseline (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in hemoglobin</measure>
    <time_frame>Measured at weeks 0,4,8,12,13 and follow-up (week 14)</time_frame>
    <description>Change from baseline (%)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSP3 (2.25g)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSP3 (3.75g)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GSP3</intervention_name>
    <description>Each capsule of GSP3 (previously Attiva) contains 700 mg of a mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.</description>
    <arm_group_label>GSP3 (2.25g)</arm_group_label>
    <arm_group_label>GSP3 (3.75g)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Avicel (modified Cellulose)</intervention_name>
    <description>Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose</description>
    <arm_group_label>GSP3 (2.25g)</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Body Mass Index (BMI) ≥ 27 and ≤ 35 (at least 30% overweight and 30% obese subjects)&#xD;
&#xD;
          2. Ability to follow verbal and written instructions&#xD;
&#xD;
          3. Informed Consent Form signed by the subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or lactation&#xD;
&#xD;
          2. Absence of medically approved contraceptive methods in females of childbearing&#xD;
             potential (e.g., hysterectomy, non-oral contraceptive medications or intrauterine&#xD;
             device combined with a barrier method, two combined barrier methods such as diaphragm&#xD;
             and condom or spermicide; bilateral tubal ligation and vasectomy are not acceptable&#xD;
             contraceptive methods)&#xD;
&#xD;
          3. History of allergic reaction to carboxymethylcellulose, citric acid, modified&#xD;
             cellulose, microcrystalline cellulose, and gelatin&#xD;
&#xD;
          4. Administration of investigational products within 1 month prior to Screening Visit&#xD;
&#xD;
          5. Night-shift workers&#xD;
&#xD;
          6. Subjects who stopped smoking within 6 months prior to Screening Visit or considering&#xD;
             smoking cessation during the study&#xD;
&#xD;
          7. Subjects anticipating surgical intervention during the study&#xD;
&#xD;
          8. Known type 1 or type 2 diabetes&#xD;
&#xD;
          9. History of eating disorders including binge eating (except mild binge eater)&#xD;
&#xD;
         10. Weight change &gt; 3 kg within 3 months prior to and during the Screening period&#xD;
&#xD;
         11. Supine systolic blood pressure (SBP) &gt; 150 mm Hg and/or supine diastolic blood&#xD;
             pressure (DBP) &gt; 90 mm Hg&#xD;
&#xD;
         12. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening&#xD;
             Visit&#xD;
&#xD;
         13. History of gastroesophageal reflux disease&#xD;
&#xD;
         14. History of gastric or duodenal ulcer&#xD;
&#xD;
         15. History of gastroparesis&#xD;
&#xD;
         16. History of gastric bypass or any other gastric surgery&#xD;
&#xD;
         17. History of intragastric balloon&#xD;
&#xD;
         18. History of pancreatitis&#xD;
&#xD;
         19. History of hemorrhoids&#xD;
&#xD;
         20. History of malabsorption&#xD;
&#xD;
         21. Laxative users&#xD;
&#xD;
         22. History of hepatitis B or C&#xD;
&#xD;
         23. History of human immunodeficiency virus&#xD;
&#xD;
         24. History of cancer within the past 5 years (except adequately-treated localized basal&#xD;
             cell skin cancer or in situ uterine cervical cancer)&#xD;
&#xD;
         25. Any other clinically significant disease interfering with the assessments of Attiva,&#xD;
             according to the Investigator&#xD;
&#xD;
         26. Positive serum or urine pregnancy test(s) in females of childbearing potential&#xD;
&#xD;
         27. Plasma glucose ≥ 126 mg/dL (7.0 mmol/L)&#xD;
&#xD;
         28. Abnormal serum thyrotropin (TSH)&#xD;
&#xD;
         29. Serum triglycerides &gt; 500 mg/dL (5.65 mmol/L)&#xD;
&#xD;
         30. Positive test for drugs in the urine&#xD;
&#xD;
         31. Any relevant biochemical abnormality interfering with the assessments of Attiva,&#xD;
             according to the Investigator&#xD;
&#xD;
         32. Anti-obesity medications (including herbal preparations) within 1 month prior to&#xD;
             Screening Visit&#xD;
&#xD;
         33. Systemic corticosteroids within 1 month prior to Screening Visit&#xD;
&#xD;
         34. Thyroid hormones or preparations within 1 month prior to Screening Visit (except in&#xD;
             subjects on stable dose of replacement therapy for at least 1 month)&#xD;
&#xD;
         35. Any other medication known to cause weight loss or weight gain within 1 month prior to&#xD;
             Screening Visit&#xD;
&#xD;
         36. Medications treating hypertension within 1 month prior to Screening Visit&#xD;
&#xD;
         37. Medications treating dyslipidemia within 1 month prior to Screening Visit&#xD;
&#xD;
         38. Anticipated requirement for use of prohibited concomitant medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hassan Heshmati, MD</last_name>
    <role>Study Director</role>
    <affiliation>Gelesis, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hradec Králové</name>
      <address>
        <city>Hradec</city>
        <zip>500 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charles University</name>
      <address>
        <city>Prague</city>
        <zip>121 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cophenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-1958</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federico University Hospital</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto I</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>May 9, 2018</last_update_submitted>
  <last_update_submitted_qc>May 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>weight loss</keyword>
  <keyword>body composition</keyword>
  <keyword>glycemic control</keyword>
  <keyword>satiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</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/NCT03008954
org study id: Attiva-03
nct id: NCT03008954
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The FLOW (First Loss Of Weight) study is designed to assess the effects of repeated
      administration of GSP3, an investigational product, on body weight. It is a multicenter,
      randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. FLOW is being
      conducted in 5 medical centers in Italy, Czech Republic, and Denmark, and will randomize 123
      overweight and obese adult males and females to receive either placebo, GSP3 (2.25g), or GSP3
      (3.75g) in addition to a hypocaloric diet (-600 kcal/day) for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Body Weight
time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
description: Change from baseline in kilograms and percent (%) weight
measure: Body weight responders
time frame: 12 weeks
description: Change from baseline in body weight of at least 5%
measure: Change in waist circumference
time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
description: Change from baseline in waist circumference (centimeters)
measure: Change in fat mass
time frame: Measured at weeks 0 and 13
description: Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)
measure: Change in bone-free fat mass
time frame: Measured at weeks 0 and 13
description: Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)
measure: Change in appetite (hunger, satiety, and fullness)
time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
description: Assessed by self-administered Visual Analog Scale (VAS)
measure: Change in food intake
time frame: Measured at weeks 0 and 12
description: Assessed by 24 hr dietary recall
measure: Change in plasma glucose
time frame: Measured at baseline and week 13
description: Change from baseline in millimoles per liter (mmol/L)
measure: Change in plasma glucose status (normal, impaired, diabetic)
time frame: Measured at weeks 0 and 13
measure: Change in serum insulin
time frame: Measured at weeks 0 and 13
description: Change from baseline in miliunits per liter (mU/L)
measure: Change in insulin resistance
time frame: Measured at weeks 0 and 13
description: Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)
measure: Change in glycosylated hemoglobin (HbA1c)
time frame: Measured at weeks 0 and 13
description: Measured in percentage (%)
measure: Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides
time frame: Measured at weeks 0 and 13
description: measured in mg/dL
measure: Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP)
time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
description: Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure
measure: All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms
time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
description: Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire
measure: Change in serum sodium
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline in millimoles per liter (mmol/L)
measure: Change in serum potassium
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (mmol/L)
measure: Change in serum coloride
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (mmol/L)
measure: Change in serum calcium
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (mmol/L)
measure: Change in serum magnesium
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (mmol/L)
measure: Change in serum phosphorus
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (mmol/L)
measure: Change in serum glucose
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (mmol/L)
measure: Change in blood urea nitrogen (BUN)
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (mmol/L)
measure: Change in serum creatinine
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline in micromoles per liter (umol/L)
measure: Change in serum uric acid
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (umol/L)
measure: Change in total bilirubin
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (umol/L)
measure: Change in alanine aminotransferase (ALT)
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline in international units per liter (IU/L)
measure: Change in aspartate transaminase (AST)
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (IU/L)
measure: Change in gamma-glutamyl transpeptidase (GGT)
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (IU/L)
measure: Change in alkaline phosphatase (ALP)
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (IU/L)
measure: Change in serum total protein
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline in grams per liter (g/L)
measure: Change in serum albumin
time frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
description: Change from baseline (g/L)
measure: Change in hematocrit
time frame: Measured at weeks 0,4,8,12,13 and follow-up (week 14)
description: Change from baseline (%)
measure: Change in hemoglobin
time frame: Measured at weeks 0,4,8,12,13 and follow-up (week 14)
description: Change from baseline (%)
arm group label: Placebo
arm group type: Placebo Comparator
description: Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner.
arm group label: GSP3 (2.25g)
arm group type: Experimental
description: GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner
arm group label: GSP3 (3.75g)
arm group type: Experimental
description: GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner
intervention type: Device
intervention name: GSP3
description: Each capsule of GSP3 (previously Attiva) contains 700 mg of a mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.
arm group label: GSP3 (2.25g)
arm group label: GSP3 (3.75g)
intervention type: Dietary Supplement
intervention name: Avicel (modified Cellulose)
description: Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose
arm group label: GSP3 (2.25g)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hassan Heshmati, MD
role: Study Director
affiliation: Gelesis, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
country: Czechia
country: Denmark
country: Italy
responsible party type: Sponsor
mesh term: Overweight
mesh term: Body Weight
sharing ipd: Undecided