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

Gelesis

Status

Completed

Conditions

Overweight

Obesity

Treatments

Device: Gelesis100

Device: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02307279

G-04

Details and patient eligibility

About

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.

Full description

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

Enrollment

436 patients

Sex

All

Ages

22 to 65 years old

Volunteers

No Healthy Volunteers

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