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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376802
• Other study ID #: PDY15012
• Secondary ID: U1111-1191-5658
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2018
• Est. completion date: December 27, 2018

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 27, 2018
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• SAR425899
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
• Placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Locations

Country	Name	City	State
United States	Investigational Site Number 8400002	Baton Rouge	Louisiana
United States	Investigational Site Number 8400001	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep energy expenditure	Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo	Baseline to Day 19
Secondary	Total daily energy expenditure	Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo	Baseline to Day 19
Secondary	Resting energy expenditure	Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo	Baseline to Day 19
Secondary	Basal energy expenditure	Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo	Baseline to Day 19
Secondary	Respiratory quotient (RQ)	Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo	Baseline to Day 19
Secondary	Fat mass and fat-free mass	Change of fat mass and fat-free mass by dual energy X-ray absorptiometry (DEXA) scan from baseline to Day 20 with SAR425899 or placebo	Baseline to Day 20
Secondary	Diet Induced Thermogenesis (DIT)	Change of DIT from baseline to Day 19 with SAR425899 or placebo	Baseline to Day 19
Secondary	Fasting plasma glucose	Change of FPG over time with SAR425899 or placebo	20 days
Secondary	HbA1c	Change of HbA1c from baseline to Day 20 with SAR425899 or placebo	Baseline to Day 20
Secondary	Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)	Change of lipid biomarkers over time with SAR425899 or placebo	20 days
Secondary	Ketone bodies	Change of ketone bodies over time with SAR425899 or placebo	20 days
Secondary	Adverse events	Number of adverse events in patients under treatment with SAR425899 or placebo	Up to 27 days
Secondary	Pharmacokinetics	Assessment of SAR425899: time to reach Cmax (tmax)	Day 16
Secondary	Pharmacokinetics	Assessment of SAR425899: maximum plasma concentration (Cmax)	Day 16
Secondary	Pharmacokinetics	Assessment of SAR425899: area under the concentration versus time curve (AUC)	Day 16
Secondary	Pharmacokinetics	Assessment of SAR425899: terminal elimination half-life (t1/2)	Day 16