Status:
COMPLETED
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03376802
Start Date
April 18 2018
End Date
December 27 2018
Last Update
April 25 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site Number 8400001
Orlando, Florida, United States, 32804
2
Investigational Site Number 8400002
Baton Rouge, Louisiana, United States, 70808