Title
Efficacy and Safety of Zenoctil in Reducing Body Weight
Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects
Phase
Phase 3Lead Sponsor
InQpharm GroupStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
OverweightStudy Participants
92The 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.
3 tablets 2 times daily
3 tablets 2 times daily
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
| Event Type | Organ System | Event Term |
|---|
Change in mean body weight at week 12 compared to baseline.
Change in mean body fat at week 12 compared to baseline
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
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".
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
The investigators evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Outcome Measure Data Not Reported
The subjects evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Outcome Measure Data Not Reported
The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Outcome Measure Data Not Reported
