Extension Study of Gelesis100 on Body Weight

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Device: Gelesis100 (2.25 g)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Percent (%) change from baseline | Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 | 
| Body weight responders (5%) | Change from baseline in body weight of at least 5% | Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma glucose status (normal, impaired, diabetic) |  | Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 | 
| Change in plasma glucose | Change from baseline in millimoles per liter (mmol/L) | Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 | 
| Change in insulin resistance | Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR) | Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 | 
| Change in glycosylated hemoglobin (HbA1c) | Change from baseline (%) | Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 | 
| Change in body mass index (BMI) | Measured as body weight in kilograms divided by height in meters-squared (kg/m2) | Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339 |