Inclusion criteria :|
- Overweight to obese male and female subjects.
- Body mass index 28 - 35 kg/m2.
- 18 to 45 years of age
- Fasting plasma glucose â‰¤125 mg/dL.
- Glycated hemoglobin (HbA1c) â‰¤6.5%.
- Obesity associated mild concomitant diseases allowed (eg, mild hypertension, mild
hypercholesteremia, and hyperlipidemia).
- No concomitant medication allowed except stable treatment with statins or
antihypertensive drugs (except ÃŸ-blocker).
- Females should be either postmenopausal, or, if perimenopausal should have a normal
regular menstrual cycle and should start or continue stable treatment with a
monophasic oral contraceptive.
- Elevated liver enzymes, lipase, amylase, or calcitonin at screening.
- Current participation in an organized diet / weight reduction program or clinical
trial of weight control or weight loss attempt, plans for major changes in physical
activities or significant change in body weight in the 2 months prior to screening.
- Any condition possibly affecting gastric emptying or absorption from gastro-intestinal
tract (eg, gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes,
gastroparesis, abdominal surgery other than appendectomy or hysterectomy.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.