Efficacy and Safety of Zenoctil in Reducing Body Weight
Status and phase
Completed
Phase 3
Conditions
Overweight
Treatments
Other: Placebo
Dietary Supplement: Zenoctil
Details and patient eligibility
About
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.
Enrollment
92 patients
Sex
All
Ages
18 to 60 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
92 participants in 2 patient groups, including a placebo group
Zenoctil
Active Comparator group
Treatment:
Dietary Supplement: Zenoctil
Placebo
Placebo Comparator group
Treatment:
Other: Placebo
Trial contacts and locations
1
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2025 Veeva Systems