OverweightPhase 3NCT01423617
Efficacy and Safety of Zenoctil in Reducing Body Weight
A Phase 3 study testing Zenoctil in people with Overweight, run by InQpharm Group at 1 site in Germany.
Trial summary
The intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind, placebo-controlled, parallel study conducted in Caucasian subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Zenoctil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Dec 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian males and females, age 18 to 60 years
- 25 kg/m2 ≤ BMI ≤32 kg/m2
- Expressed desire for weight loss
- Accustomed to 3 main meals a day
- Consistent and stable body weight 3 months prior to study enrollment
- Commitment to avoid the use of other weight loss products/programs during the study
Show all 9Show fewer
- Commitment to adhere to diet recommendation
- Females' agreement to use appropriate birth control methods during the active study period
- Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Who cannot join
- Known sensitivity to Garcinia cambogia, Lagerstroemia speciosa (other members of Lythraceae family), caffeine, tannins
- History of diabetes mellitus or other endocrine disorders
- Fasting blood glucose >7 mmol/L
- Treatment with systemic corticosteroids within the last 12 months
- Current use of antidepressants
- Uncontrolled hypertension (>160/110) or other uncontrolled cardiac, pulmonary, renal, or liver disease, determined to be clinically significant by the investigator
Show all 21Show fewer
- Presence of acute or history of chronic gastrointestinal disease
- Schizophrenia or other diagnosed psychiatric disorders
- Any other acute or chronic disease or any other medical condition which, in the investigator's view, may preclude subject's inclusion (e.g., cancer, HIV)
- Bariatric surgery
- Abdominal surgery within the last 6 months
- History of eating disorders like bulimia, anorexia nervosa
- Changes in the dose of estrogen, contraceptives or thyroid hormone within the last 3 months
- Pregnancy or nursing
- Any medication or use of products for the treatment of obesity (e.g., fat binder, carbohydrate blocker/starch blocker, fat burner, satiety products etc.) within the last 6 weeks
- More than 3 hours strenuous sport activity per week
- History of abuse of drugs, alcohol or medication
- Smoking cessation within the 6 months prior to this study
- Incompliance due to language difficulties
- Participation in another study during the last 4 weeks
- Clinically relevant excursions of safety parameters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects
The intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind, placebo-controlled, parallel study conducted in Caucasian subjects.
This study will also include a diet plan for each subject, calculated based on gender, age, and energy requirements; and adjusted to be slightly hypocaloric.
- Conditions
- Overweight
- Being tested
- Zenoctil, Placebo
- Keywords
- overweight, weight loss, body fat, waist circumference, satiety, appetite
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZenoctilDietary supplement
3 tablets 2 times daily
PlaceboOther
3 tablets 2 times daily
| Study group | Role | What they receive |
|---|---|---|
| Zenoctil | Active comparator | Not described Receives: Dietary Supplement: Zenoctil |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Body Weight (kg)
Change in mean body weight at week 12 compared to baseline.
Measured: 12 weeks
Change in Mean Body Fat (kg)
Change in mean body fat at week 12 compared to baseline
Measured: 12 weeks
Secondary outcomes (11)
Number of Subjects Who Lost at Least 3% of Baseline Body Weight
Measured: 12 weeks
Changes in Waist Circumference (cm)
Measured: 12 weeks
Changes in Hip Circumference
Measured: 12 weeks
Changes in Waist-hip-ratio
Measured: 12 weeks
Changes in Body Fat Content (%)
Measured: 12 weeks
Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)
Measured: 12 weeks
Subjects' Global Feeling of Satiety
Subject's feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = "no"; 1 = "slightly", 2 = "moderate" and 3 = "strong".
Measured: 12 weeks
Changes in Body Fat Free Mass (kg)
Measured: 12 weeks
Global Evaluation of Safety by Investigators
The investigators evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Measured: 12 weeks
Global Evaluation of Safety by Subjects
The subjects evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Measured: 12 weeks
Global Evaluation of Efficacy by Subjects
The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverweightStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Grube, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423617
- Sponsor's protocol ID
- INQ/005611
- Status last verified
- Apr 2015
- First submitted
- 24 Aug 2011
- Last updated
- 23 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects
- ClinicalTrials.gov ID
- NCT01423617
- Acronym / sponsor ID
- INQ/005611
- Conditions
- Overweight
- Keywords
- overweight, weight loss, body fat, waist circumference, satiety, appetite
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Posted 23 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind, placebo-controlled, parallel study conducted in Caucasian subjects.
This study will also include a diet plan for each subject, calculated based on gender, age, and energy requirements; and adjusted to be slightly hypocaloric.
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 |
|---|---|---|
| Zenoctil | Active comparator | Dietary Supplement: Zenoctil |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Caucasian males and females, age 18 to 60 years
- 25 kg/m2 ≤ BMI ≤32 kg/m2
- Expressed desire for weight loss
- Accustomed to 3 main meals a day
- Consistent and stable body weight 3 months prior to study enrollment
Key exclusion criteria (21 listed)
- Known sensitivity to Garcinia cambogia, Lagerstroemia speciosa (other members of Lythraceae family), caffeine, tannins
- History of diabetes mellitus or other endocrine disorders
- Fasting blood glucose >7 mmol/L
- Treatment with systemic corticosteroids within the last 12 months
- Current use of antidepressants
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 |
|---|---|---|
| Zenoctil3 tablets 2 times daily | Dietary supplement | Zenoctil |
| Placebo3 tablets 2 times daily | Other | Placebo |
Primary outcome
Change in Mean Body Weight (kg)
Time frame: 12 weeks
Change in mean body weight at week 12 compared to baseline.
Change in Mean Body Fat (kg)
Time frame: 12 weeks
Change in mean body fat at week 12 compared to baseline
11 secondary outcomes
Number of Subjects Who Lost at Least 3% of Baseline Body Weight
Time frame: 12 weeks
Changes in Waist Circumference (cm)
Time frame: 12 weeks
Changes in Hip Circumference
Time frame: 12 weeks
Changes in Waist-hip-ratio
Time frame: 12 weeks
Changes in Body Fat Content (%)
Time frame: 12 weeks
Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)
Time frame: 12 weeks
Subjects' Global Feeling of Satiety
Time frame: 12 weeks
Changes in Body Fat Free Mass (kg)
Time frame: 12 weeks
Global Evaluation of Safety by Investigators
Time frame: 12 weeks
Global Evaluation of Safety by Subjects
Time frame: 12 weeks
Global Evaluation of Efficacy by Subjects
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Barbara Grube, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zenoctil in people with Overweight, 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 9 inclusion and 21 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 23 Apr 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Body Weight (kg) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 23 Apr 2015.