Efficacy and Safety of Litramine in 1 Year Weight Loss Study

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

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

Study Overview

• Status: Completed
• Conditions: Weight Loss; Overweight and Obesity; Obesity; Excess Calories
• Intervention / Treatment: Dietary supplement: Placebo tablet; Dietary supplement: Litramine

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Analyze & Realize

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo tablet; 2 tablets to be taken 3 times a day after meals
Experimental: Litramine	Dietary supplement: Litramine; 2 tablets to be taken 3 times a day after meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in mean body weight (kg) of overweight subjects	Difference in mean body weight (kg) of overweight subjects after 52 weeks of IP intake in comparison between verum and placebo	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in mean body weight (kg) of all subjects	52 weeks
Difference in mean body weight (kg) of obese subjects	52 weeks
Proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Assessment of adverse events throughout the study	52 weeks
Safety parameters (Lab parameters, vital signs)	Assessment of laboratory results in full blood count, clinical chemistry, blood pressure and pulse rate	52 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Udo Bongartz, MD, Analyze & Realize

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: weight loss; Litramine; Opuntia ficus-indica
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight Changes; Obesity; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: INQ/004317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No