Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects

InQpharm Group1 site in 1 country92 target enrollmentJuly 2011

ConditionsOverweight

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Overweight
Sponsor: InQpharm Group
Enrollment: 92
Locations: 1
Primary Endpoint: Change in Mean Body Weight (kg)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

December 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

InQpharm Group

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Change in Mean Body Weight (kg)

Time Frame: 12 weeks

Change in mean body weight at week 12 compared to baseline.

Change in Mean Body Fat (kg)

Time Frame: 12 weeks

Change in mean body fat at week 12 compared to baseline

Secondary Outcomes

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)
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)
Global Evaluation of Efficacy by Subjects(12 weeks)
Changes in Body Fat Free Mass (kg)(12 weeks)
Global Evaluation of Safety by Subjects(12 weeks)