Effect of GSP3 on Body Weight in Overweight and Obese Subjects

Exclusion Criteria

• •1. Pregnancy or lactation
• •2. Absence of medically approved contraceptive methods in females of childbearing potential (e.g., hysterectomy, non-oral contraceptive medications or intrauterine device combined with a barrier method, two combined barrier methods such as diaphragm and condom or spermicide; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
• •3. History of allergic reaction to carboxymethylcellulose, citric acid, modified cellulose, microcrystalline cellulose, and gelatin
• •4. Administration of investigational products within 1 month prior to Screening Visit
• •5. Night-shift workers
• •6. Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
• •7. Subjects anticipating surgical intervention during the study
• •8. Known type 1 or type 2 diabetes
• •9. History of eating disorders including binge eating (except mild binge eater)
• •10. Weight change \> 3 kg within 3 months prior to and during the Screening period
• •11. Supine systolic blood pressure (SBP) \> 150 mm Hg and/or supine diastolic blood pressure (DBP) \> 90 mm Hg
• •12. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
• •13. History of gastroesophageal reflux disease
• •14. History of gastric or duodenal ulcer
• •15. History of gastroparesis
• •16. History of gastric bypass or any other gastric surgery
• •17. History of intragastric balloon
• •18. History of pancreatitis
• •19. History of hemorrhoids
• •20. History of malabsorption
• •21. Laxative users
• •22. History of hepatitis B or C
• •23. History of human immunodeficiency virus
• •24. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
• •25. Any other clinically significant disease interfering with the assessments of Attiva, according to the Investigator
• •26. Positive serum or urine pregnancy test(s) in females of childbearing potential
• •27. Plasma glucose ≥ 126 mg/dL (7.0 mmol/L)
• •28. Abnormal serum thyrotropin (TSH)
• •29. Serum triglycerides \> 500 mg/dL (5.65 mmol/L)
• •30. Positive test for drugs in the urine
• •31. Any relevant biochemical abnormality interfering with the assessments of Attiva, according to the Investigator
• •32. Anti-obesity medications (including herbal preparations) within 1 month prior to Screening Visit
• •33. Systemic corticosteroids within 1 month prior to Screening Visit
• •34. Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
• •35. Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit
• •36. Medications treating hypertension within 1 month prior to Screening Visit
• •37. Medications treating dyslipidemia within 1 month prior to Screening Visit
• •38. Anticipated requirement for use of prohibited concomitant medications