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