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

Sanofi24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Investigational Site Number 8400001

Orlando, Florida, United States

Investigational Site Number 8400002

Baton Rouge, Louisiana, United States