Clinical trial NCT03376802: A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-12-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.

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 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.

Primary outcomes:
measure: Sleep energy expenditure
timeFrame: Baseline to Day 19
Secondary outcomes:
measure: Total daily energy expenditure
timeFrame: Baseline to Day 19
measure: Resting energy expenditure
timeFrame: Baseline to Day 19
measure: Basal energy expenditure
timeFrame: Baseline to Day 19
measure: Respiratory quotient (RQ)
timeFrame: Baseline to Day 19
measure: Fat mass and fat-free mass
timeFrame: Baseline to Day 20
measure: Diet Induced Thermogenesis (DIT)
timeFrame: Baseline to Day 19
measure: Fasting plasma glucose
timeFrame: 20 days
measure: HbA1c
timeFrame: Baseline to Day 20
measure: Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)
timeFrame: 20 days
measure: Ketone bodies
timeFrame: 20 days
measure: Adverse events
timeFrame: Up to 27 days
measure: Pharmacokinetics
timeFrame: Day 16
measure: Pharmacokinetics
timeFrame: Day 16
measure: Pharmacokinetics
timeFrame: Day 16
measure: Pharmacokinetics
timeFrame: Day 16
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Investigational Site Number 8400001
state: Florida
city: Baton Rouge
country: United States
facility: Investigational Site Number 8400002
state: Louisiana
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: