A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 3/7/2019 |
| Start Date: | April 18, 2018 |
| End Date: | December 27, 2018 |
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.
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.
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.
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