CompletedNot Applicable

Efficacy and Safety of Litramine in 1 Year Weight Loss Study

Germany166 participantsStarted 2017-08-14

Plain-language summary

To evaluate the efficacy of Litramine in reducing body weight in the context of an energy-restricted diet in overweight and moderately obese subjects

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:

✕. 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.:
✕. Significant surgery within the last 6 months prior to V1:
✕. 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:
✕. Any electronic medical implant
✕. Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study:

Difference in mean body weight (kg) of overweight subjects

Timeframe: 52 weeks

NCT IDNCT03227276

SponsorInQpharm Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-19

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:

✕. 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.:
✕. Significant surgery within the last 6 months prior to V1:
✕. 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:
✕. Any electronic medical implant
✕. Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study: