Clinical trial NCT01423617: Efficacy and Safety of Zenoctil in Reducing Body Weight
Official title: Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Keywords: overweight
weight loss
body fat
waist circumference
satiety
appetite
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean Body Weight (kg)
timeFrame: 12 weeks
measure: Change in Mean Body Fat (kg)
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Subjects Who Lost at Least 3% of Baseline Body Weight
timeFrame: 12 weeks
measure: Changes in Waist Circumference (cm)
timeFrame: 12 weeks
measure: Changes in Hip Circumference
timeFrame: 12 weeks
measure: Changes in Waist-hip-ratio
timeFrame: 12 weeks
measure: Changes in Body Fat Content (%)
timeFrame: 12 weeks
measure: Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)
timeFrame: 12 weeks
measure: Subjects' Global Feeling of Satiety
timeFrame: 12 weeks
measure: Changes in Body Fat Free Mass (kg)
timeFrame: 12 weeks
measure: Global Evaluation of Safety by Investigators
timeFrame: 12 weeks
measure: Global Evaluation of Safety by Subjects
timeFrame: 12 weeks
measure: Global Evaluation of Efficacy by Subjects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Barbara Grube
Study officials:
name: Barbara Grube, MD
role: PRINCIPAL_INVESTIGATOR
References: