Efficacy and Safety of Litramine in 1 Year Weight Loss Study (NCT03227276) | Clinical Trial Compass
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
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Exclusion criteria
. Known allergy or hypersensitivity to the components of the investigational products or source plants
. Pathological electrocardiogram (ECG) at V1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in mean body weight (kg) of overweight subjects
. 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: