Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes

Study Overview
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Brief Summary
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This study will asses the decrease in body weight after repeated administration of Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes.

Detailed Description
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To asses the decrease in body weight after repeated administration of Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Device: Gelesis100
* Device: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 22 to 65 years of age, inclusive Signed Informed Consent Form BMI 27 to 40, inclusive (BMI of <30 should have at least one comorbidity) Fasting plasma glucose 90mg/dL to 145 mg/dL, inclusive; non-diabetic normoglycemic (fasting glucose 90 mg/dL to 100 mg/dL, inclusive); non-diabetic impaired fasting glucose 100mg/dL to 126 mg/dL; and diabetic: untreated (126 mg/dL to 145 mg/dL, inclusive) and metformin-treated (metformin dose 1500mg/DL and less, fasting glucose less than 145 mg/dL, inclusive) Exclusion Criteria: Pregnancy or lactation Absence of medically approved contraceptive methods in females of childbearing potential History of allergic reaction to modified cellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, and titanium oxide Administration of investigational products within 1 month prior to Screening Visit Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study Subjects anticipating surgical intervention during the study Known Type 1 diabetes History of eating disorders Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit History of: swallowing disorders, esophogeal anatomic abnormalities, gastroesophageal reflux disease, gastric or duodenal ulcer, gastroparesis (chronic nausea, vomiting, heartburn...), gastric bypass or other gastric surgery, intestinal obstruction or at high risk of including suspected small bowel adhesion, pancreatitis, malabsorption, history of bowel resection (except if related to appendectomy), history of abdominal radiation treatment Laxative users History of: HIV, hepatitis B or C; cancer within the past 5 years Abnormal serum thyroid-stimulating hormone (TSH) Positive urine drug test Anti-obesity medication within 1 month prior to Screening Visit (except stable doses of metformin, no more than 1500 mg/day, for at leaset 1 month in subjects with type 2 diabetes) Systemic corticosteroids within 1 month prior to Screening Visit Thyroid hormones or preparations within 1 month prior to Screening Visit Estrogen within 1 month prior to Screening Visit Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit TSH suppression therapy for thyroid cancer medications requiring mandatory administration with meal (lunch or dinner), except metformin Other medication or product used for chronic diseases if their impaired gastrointestinal absorption can cause safety issues Change in medications treating hypertension and/or dyslipidemia within 1 month prior to Screening Visit (including change in dose) Anticipated requirement for use of prohibited concomitant medication

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gelesis100<br>Gelesis100 twice daily | Device: Gelesis100<br> <br> |
| Placebo Comparator: Placebo<br>Matching placebo twice daily | Device: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-Primary Outcome: Percent Change in Body Weight | Percent change in body weight from Baseline to Day 171 is presented. | Baseline to Day 171 | 
| Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5% | Percentage of participants who achieve a body weight loss ≥ 5% from Baseline to Day 171 is presented. | Baseline to Day 171 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline | Impaired plasma glucose status is defined as Fasting Plasma Glucose (FPG) ≥100mg/dL and <126mg/dL at baseline measurement. | Baseline to Day 171 | 
| Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline. | Normal plasma glucose status is defined FPG ≤ 100mg/dL. Impaired plasma glucose status is defined as FPG ≥100mg/dL and <126mg/dL. Diabetic plasma glucose status was defined as FPG >126mg/dL. | Baseline to Day 171 | 
| Percent Change in Plasma Glucose | Percent change in Plasma Glucose in subjects with impaired glucose and T2D at baseline. Impaired plasma glucose is defined as FPG≥100mg/dL and FPG<126mg/dL. | Baseline to Day 171 | 
| Change in Body Mass Index (BMI) | The BMI was calculated using height (in cm) and weight (in kg) according to the following formula: BMI (kg/m2((superscript 1)) = Weight (kg)/[Height (cm)/100]2(superscript2). | Baseline to Day 171 | 
| Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline | To assess the decrease in HbA1c after repeated administration of Gelesis 100 over a period of 168 days in overweight and obese people with type 2 diabetes, The glycosylated hemoglobin was measured in mmol/mol. | Baseline to Day 171 |