Clinical trial NCT03227276: Efficacy and Safety of Litramine in 1 Year Weight Loss Study
Official title: Double-blind, Randomised, Placebo-controlled 1-year Study to Evaluate the Efficacy and Safety of Litramine in Reducing Body Weight in Overweight and Moderately Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity; Excess Calories
Overweight and Obesity
Weight Loss
Keywords: Litramine
Opuntia ficus-indica
weight loss
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2017-07-24
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Men and women from 18 to 70 years old
2. 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
3. Generally in good health
4. Desire to lose weight
5. Readiness and ability to complete the 1-year study, according to investigator's judgement following the screening interview
6. Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
7. Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self- reported change)
8. 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
9. Women of childbearing potential:

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

Exclusion Criteria:

1. Known allergy or hypersensitivity to the components of the investigational products or source plants
2. Pathological electrocardiogram (ECG) at V1
3. 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
4. Significant surgery within the last 6 months prior to V1:

   * GI surgery
   * liposuction
5. History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1
6. 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)
7. Any electronic medical implant
8. 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.)
9. 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)
10. Women of child-bearing potential: pregnancy or nursing
11. History of or current abuse of drugs, alcohol or medication
12. Participation in another clinical study in the 30 days prior to V1 and during the study
13. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures

Primary outcomes:
measure: Difference in mean body weight (kg) of overweight subjects
timeFrame: 52 weeks
Secondary outcomes:
measure: Difference in mean body weight (kg) of all subjects
timeFrame: 52 weeks
measure: Difference in mean body weight (kg) of obese subjects
timeFrame: 52 weeks
measure: Proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight
timeFrame: 52 weeks
Other outcomes:
measure: Adverse effects
timeFrame: 52 weeks
measure: Safety parameters (Lab parameters, vital signs)
timeFrame: 52 weeks
Locations:
city: Berlin
country: Germany
facility: Analyze & Realize
Study officials:
affiliation: Analyze & Realize
name: Udo Bongartz, MD
role: PRINCIPAL_INVESTIGATOR
References: