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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-06-30

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.

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gelesis100

Gelesis100 twice daily

Group Type EXPERIMENTAL

Gelesis100

Intervention Type DEVICE

Placebo

Matching placebo twice daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DEVICE

Interventions

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Gelesis100

Intervention Type DEVICE

placebo

Intervention Type DEVICE

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

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No