Obesity; Excess CaloriesNCT03227276
Efficacy and Safety of Litramine in 1 Year Weight Loss Study
A study testing Litramine in people with Obesity; Excess Calories and Overweight and Obesity, run by InQpharm Group at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity; Excess Calories, Overweight and Obesity, Weight Loss
- What is being tested?
- Litramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteGermany
- Study dates
- 14 Aug 2017to 19 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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:
- 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
- Women of childbearing potential:
- commitment to use contraception methods
- negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- Written informed consent
Who cannot join
- 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.:
- 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.
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- 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
- Significant surgery within the last 6 months prior to V1:
- GI surgery
- liposuction
- 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:
- 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)
- Any electronic medical implant
- 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.)
- 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)
- Women of child-bearing potential: pregnancy or nursing
- History of or current abuse of drugs, alcohol or medication
- Participation in another clinical study in the 30 days prior to V1 and during the study
- Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Trial locations and contacts
1 site in 1 country.
About this 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
To evaluate the efficacy of Litramine in reducing body weight in the context of an energy-restricted diet in overweight and moderately obese subjects
- Being tested
- Litramine, Placebo tablet
- Keywords
- Litramine, Opuntia ficus-indica, weight loss
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LitramineDietary supplement
2 tablets to be taken 3 times a day after meals
Placebo tabletDietary supplement
2 tablets to be taken 3 times a day after meals
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo tablet |
| Litramine | Experimental | Not described Receives: Dietary Supplement: Litramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 52 weeks
Secondary outcomes (3)
Difference in mean body weight (kg) of all subjects
Measured: 52 weeks
Difference in mean body weight (kg) of obese subjects
Measured: 52 weeks
Proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start14 Aug 2017
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity; Excess CaloriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Udo Bongartz, MD, Principal investigator, Analyze & Realize
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227276
- Sponsor's protocol ID
- INQ/004317
- Status last verified
- Feb 2020
- First submitted
- 19 Jul 2017
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03227276
- Acronym / sponsor ID
- INQ/004317
- Keywords
- Litramine, Opuntia ficus-indica, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo tablet |
| Litramine | Experimental | Dietary Supplement: Litramine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (27 listed)
- 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.:
- inflammatory bowel disease, coeliac disease, pancreatitis etc.)
- Significant surgery within the last 6 months prior to V1:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Litramine2 tablets to be taken 3 times a day after meals | Dietary supplement | Litramine |
| Placebo tablet2 tablets to be taken 3 times a day after meals | Dietary supplement | Placebo |
Primary outcome
Difference in mean body weight (kg) of overweight subjects
Time frame: 52 weeks
Difference in mean body weight (kg) of overweight subjects after 52 weeks of IP intake in comparison between verum and placebo
3 secondary outcomes
Difference in mean body weight (kg) of all subjects
Time frame: 52 weeks
Difference in mean body weight (kg) of obese subjects
Time frame: 52 weeks
Proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity; Excess Calories
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Obesity, Weight Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udo Bongartz, MD principal investigator
Analyze & Realize
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Litramine in people with Obesity; Excess Calories and Overweight and Obesity, run by InQpharm Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean body weight (kg) of overweight subjects (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.