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

CompletedPhase 1

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: SAR425899, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (2)

Orlando, Florida, United States
Baton Rouge, Louisiana, United States