Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects w/o Type 2 Diabetes

Exclusion Criteria

• •1. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential)
• •2. Absence of medically approved contraception in females of childbearing potential (e.g., hysterectomy, oral contraceptive medications, intrauterine device combined with a barrier method, two (2) combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are acceptable contraceptive methods when combined with a single method above)
• •3. History of allergic reaction to CMC, citric acid, sodium stearyl fumarate, maltodextrin, gelatin, or titanium dioxide
• •4. Participation in a weight loss study within the past six (6) months
• •5. Administration of GSP2, GSP3, Gelesis100, or Gelesis200 in a previous study
• •6. Administration of investigational products within one (1) month prior to Screening Visit 1
• •7. Blood transfusion within three (3) months prior to Screening Visit 1
• •8. Smoking cessation within six (6) months prior to Screening Visit 1 or considering smoking cessation during the study
• •9. Anticipated surgical intervention during the study period
• •10. Known Type 1 Diabetes
• •11. History of eating disorders including binge eating (except mild binge eating) or emesis ≥2/week from any cause within six (6) months prior to Screening Visit 1
• •12. Weight change ≥3% within three (3) months prior to and during the Screening period
• •13. Supine SBP \>160 mm Hg and/or supine DBP \>95 mm Hg
• •14. Angina, coronary bypass, or myocardial infarction within six (6) months prior to Screening Visit 1
• •15. History of swallowing disorders within six (6) months prior to Screening Visit 1
• •16. Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)
• •17. History of gastric or duodenal ulcer within six (6) months prior to Screening Visit 1
• •18. History of gastroparesis (e.g., chronic nausea, vomiting ≥2 occurrences per week, heartburn, etc.) within six (6) months prior to Screening Visit 1
• •19. History of gastric bypass or any other gastric surgery
• •20. History of inflammatory bowel diseases
• •21. History of intestinal stricture (e.g., Crohn's disease)
• •22. History of intestinal obstruction or high risk of intestinal obstruction, including suspected small bowel adhesions
• •23. History of pancreatitis within six (6) months prior to Screening Visit 1
• •24. History of malabsorption within six (6) months prior to Screening Visit 1
• •25. Laxative users, except those on stable doses within one (1) month prior to Screening Visit 1
• •26. History of hepatitis B or C within six (6) months prior to Screening Visit 1
• •27. History of HIV
• •28. History of cancer within the past five (5) years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
• •29. Any other clinically significant disease interfering with the assessments of Gelesis200 (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
• •30. Abnormal serum TSH
• •31. HbA1c \>8.5% (\>69 mmol/mol)
• •32. Serum LDL cholesterol ≥160 mg/dL (≥4.15 mmol/L)
• •33. Serum triglycerides ≥350 mg/dL (≥3.96 mmol/L)
• •34. Positive test for drugs of abuse in the urine
• •35. Any relevant biochemical abnormality interfering with the assessments of Gelesis200
• •36. Anti-obesity medications (including herbal preparations) within one (1) month prior to Screening Visit 1
• •37. Systemic corticosteroids within one (1) month prior to Screening Visit 1
• •38. Thyroid hormones or preparations within one (1) month prior to Screening Visit 1 \[except stable dose of replacement therapy for at least two (2) months\]
• •39. TSH suppression therapy for thyroid cancer
• •40. Estrogen within one (1) month prior to Screening Visit 1 \[except stable dose of replacement therapy or contraceptives for at least one (1) month\]
• •41. Any other medication known to cause weight loss or weight gain within one (1) month prior to Screening Visit 1
• •42. Antidiabetic medications within one (1) month prior to Screening Visit 1 \[except stable doses of metformin and DPP-4 inhibitors for at least one (1) month in subjects with Type 2 Diabetes\]
• •43. Change in medications treating hypertension within one (1) month \[one (1) week for diuretics\] prior to Screening Visit 1
• •44. Change in medications treating dyslipidemia within one (1) month prior to Screening Visit 1
• •45. Anticipated requirement for use of prohibited concomitant medications
• •46. Any other condition that, in the opinion of the Investigator or Sponsor, would interfere with the subject's ability to participate in the study