Efficacy and Safety of Litramine in 1 Year Weight Loss Study

Inclusion criteria

• Men and women from 18 to 70 years old
• Overweight (BMI 25 kg/m2 - 29.9 kg/m2) for 80% of randomized subjects and obese (BMI 30 kg/m2 - 34.9 kg/m2) for 20% of randomized subjects
• Generally in good health
• Desire to lose weight
• Readiness and ability to complete the 1-year study, according to investigator's judgement following the screening interview
• Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
• Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self- reported change)
• Subject's agreement to comply with study procedures, in particular:

• to take IP as recommended
• to avoid the use of other weight loss and/or management products and/or programs during the study
• to adhere to diet recommendation during the study
• to complete the subject diary and study questionnaires
• Women of childbearing potential:

• commitment to use contraception methods
• negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
• Written informed consent

Exclusion criteria

• Known allergy or hypersensitivity to the components of the investigational products or source plants
• Pathological electrocardiogram (ECG) at V1
• History and/or presence of clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:

• untreated or unstable thyroid gland disorder
• untreated or unstable hypertension (regular blood pressure >140/90 mm Hg)
• acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g.

inflammatory bowel disease, coeliac disease, pancreatitis etc.)

• diabetes mellitus type 1
• untreated or unstable diabetes mellitus type 2
• any other serious organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject
• Significant surgery within the last 6 months prior to V1:

• GI surgery
• liposuction
• History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1
• Deviation of safety laboratory parameter(s) at V1 that is:

• clinically significant or
• >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
• Any electronic medical implant
• Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study:

• that could influence body weight (e.g. systemic corticosteroids)
• that could influence gastrointestinal functions (e.g. laxatives, opioids, anticholinergics etc.) as per investigator judgement
• for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products, acupuncture etc.)
• Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)
• Women of child-bearing potential: pregnancy or nursing
• History of or current abuse of drugs, alcohol or medication
• Participation in another clinical study in the 30 days prior to V1 and during the study
• Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures