Effect of GSP3 on Body Weight in Overweight and Obese Subjects

Inclusion criteria

• Body Mass Index (BMI) ≥ 27 and ≤ 35 (at least 30% overweight and 30% obese subjects)
• Ability to follow verbal and written instructions
• Informed Consent Form signed by the subjects

Exclusion criteria

• Pregnancy or lactation
• 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)
• History of allergic reaction to carboxymethylcellulose, citric acid, modified cellulose, microcrystalline cellulose, and gelatin
• Administration of investigational products within 1 month prior to Screening Visit
• Night-shift workers
• 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 or type 2 diabetes
• History of eating disorders including binge eating (except mild binge eater)
• Weight change > 3 kg within 3 months prior to and during the Screening period
• Supine systolic blood pressure (SBP) > 150 mm Hg and/or supine diastolic blood pressure (DBP) > 90 mm Hg
• Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
• History of gastroesophageal reflux disease
• History of gastric or duodenal ulcer
• History of gastroparesis
• History of gastric bypass or any other gastric surgery
• History of intragastric balloon
• History of pancreatitis
• History of hemorrhoids
• History of malabsorption
• Laxative users
• History of hepatitis B or C
• History of human immunodeficiency virus
• History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
• Any other clinically significant disease interfering with the assessments of Attiva, according to the Investigator
• Positive serum or urine pregnancy test(s) in females of childbearing potential
• Plasma glucose ≥ 126 mg/dL (7.0 mmol/L)
• Abnormal serum thyrotropin (TSH)
• Serum triglycerides > 500 mg/dL (5.65 mmol/L)
• Positive test for drugs in the urine
• Any relevant biochemical abnormality interfering with the assessments of Attiva, according to the Investigator
• Anti-obesity medications (including herbal preparations) within 1 month prior to Screening Visit
• Systemic corticosteroids within 1 month prior to Screening Visit
• 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)
• Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit
• Medications treating hypertension within 1 month prior to Screening Visit
• Medications treating dyslipidemia within 1 month prior to Screening Visit
• Anticipated requirement for use of prohibited concomitant medications