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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: SAR425899; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03376802

U1111-1191-5658 (Other Identifier)

PDY15012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

SAR425899

Experimental group

Description:

Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days

Treatment:

Drug: SAR425899

Placebo

Placebo Comparator group

Description:

Repeated once daily SC doses of placebo administered over 19 days

Treatment:

Drug: Placebo