A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Repeated Subcutaneous Doses of SAR425899 on Energy Expenditure and Safety in Overweight to Obese Male and Female Subjects

Primary Objective:

To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899.

Secondary Objectives:

• To assess the change in resting, basal and total daily energy expenditure.
• To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation.
• To assess the change in body composition and core temperature.
• To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (HbA1c).
• To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses.
• To assess the safety and tolerability.

Study duration is approximately 7-8 weeks including a screening period, a 19-day treatment period and an end-of-study visit 7 days after last dosing.

Inclusion criteria:

• Overweight to obese male and female subjects.
• Body mass index 28 - 40 kg/m2.
• 18 to 50 years of age
• Fasting plasma glucose ≤125 mg/dL.
• Glycated hemoglobine (HbA1c) ≤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 ß-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.

Exclusion criteria:

• 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.