Back to resultsExtension Study of Gelesis100 on Body Weight (GLOW-EX)
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Gelesis100 (2.25 g)
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- Completion of the GLOW study with at least 3% weight loss
- Informed Consent Form signed by the subjects at the end of the GLOW study
Exclusion Criteria:
- Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation
- 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)
- Subjects considering smoking cessation during the study
- Subjects anticipating surgical intervention during the study
- Significant intolerance to the study product during the GLOW study
- 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)
- 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)
- 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
- Poor subject compliance with the GLOW study procedures and recommendations and/or major protocol deviation
- Anticipated requirement for use of prohibited concomitant medications
Sites / Locations
- Arternis Institute for Clinical Research
- Clinical Trial Investigators
- University of Colorado
- Westside Center for Clinical Research
- Pennington Biomedical Research
- Boston University Medical Center
- Cornell Weill Medical College
- Radiant Research
- Aventiv Research
- Geisinger Health System
- Texas Diabetes and Endocrinology
- Health & Care SRO
- University of Cophenhagen
- IRCCS Policlinico San Donato
- University of Rome
- University of Navarra
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gelesis100
Arm Description
Gelesis100 (2.25 g) twice daily
Outcomes
Primary Outcome Measures
Change in body weight
Percent (%) change from baseline
Body weight responders (5%)
Change from baseline in body weight of at least 5%
Secondary Outcome Measures
Change in plasma glucose status (normal, impaired, diabetic)
Change in plasma glucose
Change from baseline in millimoles per liter (mmol/L)
Change in insulin resistance
Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)
Change in glycosylated hemoglobin (HbA1c)
Change from baseline (%)
Change in body mass index (BMI)
Measured as body weight in kilograms divided by height in meters-squared (kg/m2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03021291
Brief Title
Extension Study of Gelesis100 on Body Weight
Acronym
GLOW-EX
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
December 8, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gelesis, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gelesis100
Arm Type
Experimental
Arm Description
Gelesis100 (2.25 g) twice daily
Intervention Type
Device
Intervention Name(s)
Gelesis100 (2.25 g)
Intervention Description
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 Measure Information:
Title
Change in body weight
Description
Percent (%) change from baseline
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Body weight responders (5%)
Description
Change from baseline in body weight of at least 5%
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Secondary Outcome Measure Information:
Title
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
Title
Change in plasma glucose
Description
Change from baseline in millimoles per liter (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in insulin resistance
Description
Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in glycosylated hemoglobin (HbA1c)
Description
Change from baseline (%)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in body mass index (BMI)
Description
Measured as body weight in kilograms divided by height in meters-squared (kg/m2)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other Pre-specified Outcome Measures:
Title
Body weight responders (10%)
Description
Change from baseline in body weight of at least 10%
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in excess body weight
Description
Change from baseline (%)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
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
Title
Change in waist circumference
Description
Change from baseline in waist circumference (centimeters)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum insulin
Description
Change from baseline in milliunits per liter (mU/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum C-reactive protein (CRP)
Description
Measured in milligrams per liter (mg/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides
Description
measured in milligrams per deciliter (mg/dL)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP)
Description
Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in food intake
Description
Assessed by 24 hr dietary recall
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in Impact of Weight on Quality Of Life (IWQOL)
Description
Change in global and individual questionnaire subscale scores
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms
Description
Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire.
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum sodium
Description
Change from baseline in millimoles per liter (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum potassium
Description
Change from baseline (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum chloride
Description
Change from baseline (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum calcium
Description
Change from baseline (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum magnesium
Description
Change from baseline (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum phosphorus
Description
Change from baseline (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum glucose
Description
Change from baseline (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in blood urea nitrogen (BUN)
Description
Change from baseline (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum creatinine
Description
Change from baseline in micromoles per liter (umol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum uric acid
Description
Change from baseline (umol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in total bilirubin
Description
Change from baseline (umol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in alanine aminotransferase (ALT)
Description
Change from baseline in international units per liter (IU/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in aspartate transaminase (AST)
Description
Change from baseline (IU/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in gamma-glutamyl transpeptidase (GGT)
Description
Change from baseline (IU/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in alkaline phosphatase (ALP)
Description
Change from baseline (IU/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum total protein
Description
Change from baseline (g/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in serum albumin
Description
Change from baseline (g/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in hematocrit
Description
Change from baseline (%)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Title
Change in hemoglobin
Description
Change from baseline (mmol/L)
Time Frame
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion of the GLOW study with at least 3% weight loss
Informed Consent Form signed by the subjects at the end of the GLOW study
Exclusion Criteria:
Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation
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)
Subjects considering smoking cessation during the study
Subjects anticipating surgical intervention during the study
Significant intolerance to the study product during the GLOW study
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)
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)
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
Poor subject compliance with the GLOW study procedures and recommendations and/or major protocol deviation
Anticipated requirement for use of prohibited concomitant medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Heshmati, MD
Organizational Affiliation
Gelesis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arternis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Trial Investigators
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Westside Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Pennington Biomedical Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Cornell Weill Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Aventiv Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Geisinger Health System
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Texas Diabetes and Endocrinology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Health & Care SRO
City
Prague
ZIP/Postal Code
182 00
Country
Czechia
Facility Name
University of Cophenhagen
City
Copenhagen
ZIP/Postal Code
DK-1958
Country
Denmark
Facility Name
IRCCS Policlinico San Donato
City
Milan
ZIP/Postal Code
20097
Country
Italy
Facility Name
University of Rome
City
Rome
ZIP/Postal Code
00186
Country
Italy
Facility Name
University of Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Extension Study of Gelesis100 on Body Weight
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