ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss

Inclusion Criteria: * Male and female subjects between the ages of 22 to 60 * A BMI between 30.0 to 40.0 kg/m2, inclusive. Subjects with a BMI of 30.0 kg/m2 to 34.9 kg/m2 are required to have one or more obesity-related comorbidities * History of obesity for at least 2 years, with history of failure of medically or commercially supervised weight loss program * \< 5% change in body weight for at least 3 months * Negative pregnancy test, agree to be on birth control for the duration of participation * Informed consent * Willing and able to comply with study procedures Exclusion Criteria: * Pregnancy or nursing * Hormonal or genetic cause for obesity * Prior history of any GI surgery or endoscopic intervention * Chronic use of medications likely to contribute to weight gain or prevent weight loss * Gastric or duodenal ulcers * Positive for H. pylori * History of severe dyspepsia * GI tract motility disorders * History of inflammatory disease of GI tract, coeliac disease, pancreatitis, portal hypertension, cirrhosis, and/or varices * Diabetes treated with insulin * HbA1c \>7.5% * Uncontrolled thyroid and adrenal gland disease or uncontrolled hypertension * History of certain cardiac events * Localized or systemic infection * Anemia * History of asthma likely to require systemic steroid therapy * Autoimmune connective tissue disorders or immunocompromised * History of malignancy except non-melanoma skin cancer * Continuous use of ulcerogenic medication * On anticoagulation or antiplatelet therapy * Use of weight-loss medication * In other weight-loss program * Unable to take proton pump inhibitor * Abnormal laboratory values or EKG * Inability to walk at least 0.8 kilometers per day * Planned surgical procedure that can impact the conduct of the study * Known allergy to any component materials in the TPSS * Smoker or user of nicotine product * Substance abuse * Severe, uncontrolled psychiatric illness * Recent inpatient psychiatric treatment * Moderate depression * Bulimia nervosa or binge eating disorder * Participation in another clinical study * Employee or family member of Sponsor or study staff * Have any endoscopic exclusion criteria