Obesity
Conditions
Keywords
Obesity
Brief summary
Primary : effect on weight loss and weight maintenance over 9 months when prescribed with a hypocaloric diet in obese patients. Secondary : effect on HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference - safety and tolerability
Interventions
DRUGPlacebo
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI)\> 25 kg/m²
Exclusion criteria
* Absence of stable weight (variation \< 5 kg) within three months prior to screening visit), * Absence of effective contraceptive method for females of childbearing potential, * Presence of treated or untreated type 1 or type 2 diabetes, * Systolic blood pressure \> 165 mm Hg and/or diastolic blood pressure \> 105 mm Hg on 2 consecutive visits from the screening to the inclusion visit, * Presence of secondary hypertension, * Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint (presence of any clinically significant endocrine disease according to the Investigator, obesity of known endocrine origin...) * Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study, * Presence of any clinically significant abnormality according to the Investigator on the ECG performed on the inclusion visit. * Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. * Related to previous or concomitant medications : * Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc). * Antidiabetic drugs. * Related to laboratory findings: * Positive test for hepatitis B surface antigen and/or hepatitis C antibody. * Abnormal TSH level (TSH \> ULN or \< LLN). * Positive urine pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in weight from baseline to month 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events). | — |
Countries
China, South Korea, Taiwan
Outcome results
None listed