<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/NCT03021291</url>
  </required_header>
  <id_info>
    <org_study_id>GS-100-009</org_study_id>
    <nct_id>NCT03021291</nct_id>
  </id_info>
  <brief_title>Extension Study of Gelesis100 on Body Weight</brief_title>
  <acronym>GLOW-EX</acronym>
  <official_title>An Open-label Study Assessing the Effect of Gelesis100 on Weight Loss and Weight Maintenance in Overweight and Obese Subjects Who Completed the GLOW Study (G-04)</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>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess the effect of Gelesis100 on body weight after an additional&#xD;
      exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least&#xD;
      3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 8, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Percent (%) change from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight responders (5%)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline in body weight of at least 5%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plasma glucose status (normal, impaired, diabetic)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma glucose</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline in millimoles per liter (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin resistance</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glycosylated hemoglobin (HbA1c)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index (BMI)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Measured as body weight in kilograms divided by height in meters-squared (kg/m2)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body weight responders (10%)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline in body weight of at least 10%</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in excess body weight</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in body weight status (normal, overweight, obese)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline in waist circumference (centimeters)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum insulin</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline in milliunits per liter (mU/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum C-reactive protein (CRP)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Measured in milligrams per liter (mg/L)</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 baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>measured in milligrams per deciliter (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 baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in food intake</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Assessed by 24 hr dietary recall</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Impact of Weight on Quality Of Life (IWQOL)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change in global and individual questionnaire subscale scores</description>
  </other_outcome>
  <other_outcome>
    <measure>All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</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 baselines of the GLOW and GLOW-EX study (day 197) and day 339</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 baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum chloride</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum calcium</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum magnesium</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum phosphorus</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum glucose</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</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 baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum creatinine</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</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 baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (umol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in total bilirubin</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (umol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in alanine aminotransferase (ALT)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</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 baselines of the GLOW and GLOW-EX study (day 197) and day 339</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 baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (IU/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in alkaline phosphatase (ALP)</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (IU/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum total protein</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (g/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum albumin</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (g/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in hematocrit</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in hemoglobin</measure>
    <time_frame>Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339</time_frame>
    <description>Change from baseline (mmol/L)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Gelesis100</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gelesis100 (2.25 g) twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gelesis100 (2.25 g)</intervention_name>
    <description>Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.</description>
    <arm_group_label>Gelesis100</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Completion of the GLOW study with at least 3% weight loss&#xD;
&#xD;
          2. Informed Consent Form signed by the subjects at the end of the GLOW study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing&#xD;
             potential) 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, or condom and spermicide; bilateral tubal ligation and&#xD;
             vasectomy are not acceptable contraceptive methods)&#xD;
&#xD;
          3. Subjects considering smoking cessation during the study&#xD;
&#xD;
          4. Subjects anticipating surgical intervention during the study&#xD;
&#xD;
          5. Significant intolerance to the study product during the GLOW study&#xD;
&#xD;
          6. Increase of ≥ 0.5% point (≥ 5.5 mmol/mol) in HbA1c from the Baseline Visit of the GLOW&#xD;
             study in subjects with treated or untreated type 2 diabetes if considered clinically&#xD;
             relevant, or any increase if HbA1c is &gt; 8.5% (&gt; 69 mmol/mol)&#xD;
&#xD;
          7. Increase of ≥ 10% in total cholesterol, low-density lipoprotein (LDL) cholesterol, or&#xD;
             triglycerides from the Baseline Visit of the GLOW study in subjects with elevated&#xD;
             lipids at the Baseline Visit of the GLOW study if considered clinically relevant, or&#xD;
             any increase if serum LDL cholesterol is ≥ 190 mg/dL (≥ 4.93 mmol/L) and/or serum&#xD;
             triglycerides are ≥ 500 mg/dL (≥ 5.65 mmol/L)&#xD;
&#xD;
          8. Increase of ≥ 10 mm Hg in supine systolic blood pressure (SBP) and/or supine diastolic&#xD;
             blood pressure (DBP) from the Baseline Visit of the GLOW study in subjects with&#xD;
             treated or untreated hypertension if considered clinically relevant, or any increase&#xD;
             if supine SBP is &gt; 160 mm Hg and/or supine DBP is &gt; 95 mm Hg, based on the mean of two&#xD;
             consecutive readings&#xD;
&#xD;
          9. Poor subject compliance with the GLOW study procedures and recommendations and/or&#xD;
             major protocol deviation&#xD;
&#xD;
         10. Anticipated requirement for use of prohibited concomitant medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 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>Arternis Institute for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Investigators</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westside Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennington Biomedical Research</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornell Weill Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Health System</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes and Endocrinology</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health &amp; Care SRO</name>
      <address>
        <city>Prague</city>
        <zip>182 00</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>IRCCS Policlinico San Donato</name>
      <address>
        <city>Milan</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rome</name>
      <address>
        <city>Rome</city>
        <zip>00186</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>February 15, 2018</last_update_submitted>
  <last_update_submitted_qc>February 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2018</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>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 11, 2019</submitted>
    <returned>December 2, 2019</returned>
  </pending_results>
  <!-- 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/NCT03021291
org study id: GS-100-009
nct id: NCT03021291
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study is designed to assess the effect of Gelesis100 on body weight after an additional
      exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least
      3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in body weight
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Percent (%) change from baseline
measure: Body weight responders (5%)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline in body weight of at least 5%
measure: Change in plasma glucose status (normal, impaired, diabetic)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in plasma glucose
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline in millimoles per liter (mmol/L)
measure: Change in insulin resistance
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)
measure: Change in glycosylated hemoglobin (HbA1c)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (%)
measure: Change in body mass index (BMI)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Measured as body weight in kilograms divided by height in meters-squared (kg/m2)
measure: Body weight responders (10%)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline in body weight of at least 10%
measure: Change in excess body weight
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (%)
measure: Change in body weight status (normal, overweight, obese)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in waist circumference
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline in waist circumference (centimeters)
measure: Change in serum insulin
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline in milliunits per liter (mU/L)
measure: Change in serum C-reactive protein (CRP)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Measured in milligrams per liter (mg/L)
measure: Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: measured in milligrams per deciliter (mg/dL)
measure: Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure
measure: Change in food intake
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Assessed by 24 hr dietary recall
measure: Change in Impact of Weight on Quality Of Life (IWQOL)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change in global and individual questionnaire subscale scores
measure: All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire.
measure: Change in serum sodium
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline in millimoles per liter (mmol/L)
measure: Change in serum potassium
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (mmol/L)
measure: Change in serum chloride
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (mmol/L)
measure: Change in serum calcium
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (mmol/L)
measure: Change in serum magnesium
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (mmol/L)
measure: Change in serum phosphorus
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (mmol/L)
measure: Change in serum glucose
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (mmol/L)
measure: Change in blood urea nitrogen (BUN)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (mmol/L)
measure: Change in serum creatinine
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline in micromoles per liter (umol/L)
measure: Change in serum uric acid
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (umol/L)
measure: Change in total bilirubin
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (umol/L)
measure: Change in alanine aminotransferase (ALT)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline in international units per liter (IU/L)
measure: Change in aspartate transaminase (AST)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (IU/L)
measure: Change in gamma-glutamyl transpeptidase (GGT)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (IU/L)
measure: Change in alkaline phosphatase (ALP)
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (IU/L)
measure: Change in serum total protein
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (g/L)
measure: Change in serum albumin
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (g/L)
measure: Change in hematocrit
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (%)
measure: Change in hemoglobin
time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
description: Change from baseline (mmol/L)
arm group label: Gelesis100
arm group type: Experimental
description: Gelesis100 (2.25 g) twice daily
intervention type: Device
intervention name: Gelesis100 (2.25 g)
description: Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.
arm group label: Gelesis100
criteria: 
gender: All
minimum age: 22 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hassan Heshmati, MD
role: Study Director
affiliation: Gelesis, Inc.
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country: Czechia
country: Denmark
country: Italy
country: Spain
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: Undecided
submitted: November 11, 2019
returned: December 2, 2019