Safety and Efficacy of Litramine in Overweight and Obese Subjects

Inclusion Criteria:

• 25 ≤ BMI ≤ 35

• Expressed desire for weight loss

• Accustomed to 3 main meals/day

• Consistent and stable body weight 3 months prior to study enrolment

• Commitment to avoid the use of other weight loss products during study

• Commitment to adhere to diet recommendation

• Femalesʼ agreement to use appropriate birth control methods during the active studyperiod

• Subject declares in writing his/her consent to participate, understands requirementsof the study and is willing to comply

Exclusion Criteria:

• Known sensitivity to the ingredients of the device

• Presence of any active gastrointestinal disease

• Malabsorption disorders (e.g. Coeliac disease)

• Pancreatitis

• Stenosis in the GI tract

• Bariatric surgery

• Abdominal surgery within the last 6 months prior to the study

• History of eating disorders like bulimia, anorexia nervosa

• History of renal disease

• History of nephrolithiasis

• History of cardiac diseases

• Osteoporosis

• Other serious organ or systemic diseases such as cancer, HIV, or diabetes mellitus

• Any medication that could influence GI functions such as antibiotics, laxatives,opioids, anticholinergics, or anti-diarrheals (must have stopped 3 months before studystart)

• Pregnancy or nursing

• Any medication or use of products for the treatment of obesity (e.g., Orlistat, otherfatbinder, fatburner, satiety products etc.)

• More than 3 hours serious sport activity per week

• History of abuse of drugs, alcohol or medication

• Smoking cessation within the 6 months prior to this study

• Inability to comply due to language difficulties

• Participation in similar studies or weight loss programs within the 6 months prior tothis study

• Participation in other studies within the last 4 weeks