Efficacy and Safety of Glucosanol in Maintaining Body Weight

Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects

To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.

Inclusion Criteria:

• Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
• Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
• BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
• Expressed desire for weight maintenance
• Accustomed to 3 main meals per day
• Commitment to avoid the use of other weight loss products during study
• Females' agreement to use appropriate birth control methods during the active study period
• Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

• Known sensitivity to the ingredients of the device (Phaseolus vulgaris or members of the Fabaceae family)
• History of diabetes mellitus • Fasting blood glucose more than 7 mmol/L
• History or clinical signs of endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
• Clinically relevant excursions of safety parameter
• Current use of anti-depressants
• Presence of acute or chronic gastrointestinal disease (e.g. IBD, coeliac disease, pancreatitis)
• Uncontrolled hypertension (more than 160/110 mm Hg)
• Stenosis in the GI tract
• Bariatric surgery
• Abdominal surgery within the last 6 months prior to enrollment
• History of eating disorders like bulimia, anorexia nervosa within the past 12 months
• Other serious organ or systemic diseases such as cancer
• Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals
• Pregnancy or nursing
• Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
• More than 3 hours strenuous sport activity per week
• History of abuse of drugs, alcohol or medication
• Smoking cessation within 6 months prior to enrolment
• Inability to comply due to language difficulties
• Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation