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Extension Study of Gelesis100 on Body Weight (GLOW-EX)

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ClinicalTrials.gov Identifier: NCT03021291
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Gelesis, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Device: Gelesis100 (2.25 g) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 25, 2017
Actual Primary Completion Date : December 8, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Gelesis100
Gelesis100 (2.25 g) twice daily
Device: Gelesis100 (2.25 g)
Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Percent (%) change from baseline

  2. Body weight responders (5%) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline in body weight of at least 5%


Secondary Outcome Measures :
  1. 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 ]
  2. Change in plasma glucose [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline in millimoles per liter (mmol/L)

  3. Change in insulin resistance [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)

  4. Change in glycosylated hemoglobin (HbA1c) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (%)

  5. Change in body mass index (BMI) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Measured as body weight in kilograms divided by height in meters-squared (kg/m2)


Other Outcome Measures:
  1. Body weight responders (10%) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline in body weight of at least 10%

  2. Change in excess body weight [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (%)

  3. 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 ]
  4. Change in waist circumference [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline in waist circumference (centimeters)

  5. Change in serum insulin [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline in milliunits per liter (mU/L)

  6. Change in serum C-reactive protein (CRP) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Measured in milligrams per liter (mg/L)

  7. 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 ]
    measured in milligrams per deciliter (mg/dL)

  8. 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 ]
    Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure

  9. Change in food intake [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Assessed by 24 hr dietary recall

  10. 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 ]
    Change in global and individual questionnaire subscale scores

  11. 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 ]
    Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire.

  12. Change in serum sodium [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline in millimoles per liter (mmol/L)

  13. Change in serum potassium [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (mmol/L)

  14. Change in serum chloride [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (mmol/L)

  15. Change in serum calcium [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (mmol/L)

  16. Change in serum magnesium [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (mmol/L)

  17. Change in serum phosphorus [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (mmol/L)

  18. Change in serum glucose [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (mmol/L)

  19. Change in blood urea nitrogen (BUN) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (mmol/L)

  20. Change in serum creatinine [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline in micromoles per liter (umol/L)

  21. Change in serum uric acid [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (umol/L)

  22. Change in total bilirubin [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (umol/L)

  23. Change in alanine aminotransferase (ALT) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline in international units per liter (IU/L)

  24. Change in aspartate transaminase (AST) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (IU/L)

  25. Change in gamma-glutamyl transpeptidase (GGT) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (IU/L)

  26. Change in alkaline phosphatase (ALP) [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (IU/L)

  27. Change in serum total protein [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (g/L)

  28. Change in serum albumin [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (g/L)

  29. Change in hematocrit [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (%)

  30. Change in hemoglobin [ Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 ]
    Change from baseline (mmol/L)



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Completion of the GLOW study with at least 3% weight loss
  2. Informed Consent Form signed by the subjects at the end of the GLOW study

Exclusion Criteria:

  1. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation
  2. Absence of medically approved contraceptive methods in females of childbearing potential (e.g., hysterectomy, non-oral contraceptive medications or intrauterine device combined with a barrier method, two combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
  3. Subjects considering smoking cessation during the study
  4. Subjects anticipating surgical intervention during the study
  5. Significant intolerance to the study product during the GLOW study
  6. Increase of ≥ 0.5% point (≥ 5.5 mmol/mol) in HbA1c from the Baseline Visit of the GLOW study in subjects with treated or untreated type 2 diabetes if considered clinically relevant, or any increase if HbA1c is > 8.5% (> 69 mmol/mol)
  7. Increase of ≥ 10% in total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides from the Baseline Visit of the GLOW study in subjects with elevated lipids at the Baseline Visit of the GLOW study if considered clinically relevant, or any increase if serum LDL cholesterol is ≥ 190 mg/dL (≥ 4.93 mmol/L) and/or serum triglycerides are ≥ 500 mg/dL (≥ 5.65 mmol/L)
  8. Increase of ≥ 10 mm Hg in supine systolic blood pressure (SBP) and/or supine diastolic blood pressure (DBP) from the Baseline Visit of the GLOW study in subjects with treated or untreated hypertension if considered clinically relevant, or any increase if supine SBP is > 160 mm Hg and/or supine DBP is > 95 mm Hg, based on the mean of two consecutive readings
  9. Poor subject compliance with the GLOW study procedures and recommendations and/or major protocol deviation
  10. Anticipated requirement for use of prohibited concomitant medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021291


Locations
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United States, California
Arternis Institute for Clinical Research
San Diego, California, United States, 92103
Clinical Trial Investigators
Tustin, California, United States, 92780
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Westside Center for Clinical Research
Jacksonville, Florida, United States, 32205
United States, Louisiana
Pennington Biomedical Research
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
Cornell Weill Medical College
New York, New York, United States, 10065
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45249
Aventiv Research
Columbus, Ohio, United States, 43213
United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
United States, Texas
Texas Diabetes and Endocrinology
Round Rock, Texas, United States, 78681
Czechia
Health & Care SRO
Prague, Czechia, 182 00
Denmark
University of Cophenhagen
Copenhagen, Denmark, DK-1958
Italy
IRCCS Policlinico San Donato
Milan, Italy, 20097
University of Rome
Rome, Italy, 00186
Spain
University of Navarra
Pamplona, Spain, 31008
Sponsors and Collaborators
Gelesis, Inc.
Investigators
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Study Director: Hassan Heshmati, MD Gelesis, Inc.
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Responsible Party: Gelesis, Inc.
ClinicalTrials.gov Identifier: NCT03021291    
Other Study ID Numbers: GS-100-009
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms