Obesity
Conditions
Keywords
weight loss
Brief summary
The primary objective is to verify the dose-response relationship of rimonabant on body weight change. The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Body Mass Index ≥25 kg/m² * Viceral Fat Area ≥ 100 cm² * Diet therapy for more than 8 weeks before start of the placebo observation period * Stable weight (variation \< ±3kg within 8 weeks before start of observation period) * At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| absolute change in body weight from baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure | — |
| Safety:adverse events, laboratory tests, ECGs | — |
| Pharmacokinetics: SR141716 plasma trough concentrations | — |
Countries
Japan
Outcome results
None listed