Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zenoctil | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenoctil | Dietary Supplement | 3 tablets 2 times daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Body Weight (kg) | Change in mean body weight at week 12 compared to baseline. | 12 weeks |
| Change in Mean Body Fat (kg) | Change in mean body fat at week 12 compared to baseline | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Lost at Least 3% of Baseline Body Weight | 12 weeks | |
| Changes in Waist Circumference (cm) | 12 weeks | |
| Changes in Hip Circumference |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barbara Grube, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Grube | Berlin | Germany |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zenoctil | Zenoctil: 3 tablets 2 times daily |
| FG001 | Placebo | Placebo: 3 tablets 2 times daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zenoctil | Zenoctil: 3 tablets 2 times daily |
| BG001 | Placebo | Placebo: 3 tablets 2 times daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Body Weight (kg) | Change in mean body weight at week 12 compared to baseline. | Posted | Mean | Standard Deviation | kg | 12 weeks |
|
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zenoctil | Zenoctil: 3 tablets 2 times daily |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Christof Jänicke | Analyze & Realize | +49 30 40 00 83 23 | cj@a-r.com |
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
3 tablets 2 times daily |
|
| 12 weeks |
| Changes in Waist-hip-ratio | 12 weeks |
| Changes in Body Fat Content (%) | 12 weeks |
| Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ) | 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". | 12 weeks |
| Changes in Body Fat Free Mass (kg) | 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". | 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". | 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". | 12 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Change in Mean Body Fat (kg) | Change in mean body fat at week 12 compared to baseline | Posted | Mean | Standard Deviation | kg | 12 weeks |
|
|
|
| Secondary | Number of Subjects Who Lost at Least 3% of Baseline Body Weight | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Changes in Waist Circumference (cm) | Posted | Mean | Standard Deviation | cm | 12 weeks |
|
|
|
| Secondary | Changes in Hip Circumference | Posted | Mean | Standard Deviation | cm | 12 weeks |
|
|
|
| Secondary | Changes in Waist-hip-ratio | Not Posted | 12 weeks |
| Secondary | Changes in Body Fat Content (%) | Not Posted | 12 weeks |
| Secondary | Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ) | Not Posted | 12 weeks |
| Secondary | 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". | Not Posted | 12 weeks |
| Secondary | Changes in Body Fat Free Mass (kg) | Not Posted | 12 weeks |
| Secondary | 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". | Not Posted | 12 weeks |
| Secondary | 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". | Not Posted | 12 weeks |
| Secondary | 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". | Not Posted | 12 weeks |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Placebo | Placebo: 3 tablets 2 times daily | 0 | 45 | 0 | 45 |
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |