Efficacy and Safety of Zenoctil in Reducing Body Weight

Phase 3

Completed

Brief 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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Zenoctil	Zenoctil	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Mean Body Weight (kg)	12 weeks	Change in mean body weight at week 12 compared to baseline.
Change in Mean Body Fat (kg)	12 weeks	Change in mean body fat at week 12 compared to baseline

Secondary Outcome Measures

Name	Time	Method
Changes in Body Fat Free Mass (kg)	12 weeks
Number of Subjects Who Lost at Least 3% of Baseline Body Weight	12 weeks
Changes in Hip Circumference	12 weeks
Changes in Waist-hip-ratio	12 weeks
Global Evaluation of Safety by Investigators	12 weeks	The investigators evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Changes in Waist Circumference (cm)	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	12 weeks	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".
Global Evaluation of Efficacy by Subjects	12 weeks	The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Global Evaluation of Safety by Subjects	12 weeks	The subjects evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".