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

Launched by SANOFI · Dec 12, 2017

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.