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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: SAR425899

• Registration Number: NCT03376802
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-19
• Study Start: 2018-04-18
• Primary Completion: 2018-12-27
• Study Completion: 2018-12-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Repeated once daily SC doses of placebo administered over 19 days
SAR425899	SAR425899	Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days

Primary Outcome Measures

Name	Time	Method
Sleep energy expenditure	Baseline to Day 19	Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo

Secondary Outcome Measures

Name	Time	Method
Diet Induced Thermogenesis (DIT)	Baseline to Day 19	Change of DIT from baseline to Day 19 with SAR425899 or placebo
Respiratory quotient (RQ)	Baseline to Day 19	Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo
Ketone bodies	20 days	Change of ketone bodies over time with SAR425899 or placebo
Fat mass and fat-free mass	Baseline to Day 20	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
Adverse events	Up to 27 days	Number of adverse events in patients under treatment with SAR425899 or placebo
Fasting plasma glucose	20 days	Change of FPG over time with SAR425899 or placebo
Basal energy expenditure	Baseline to Day 19	Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo
HbA1c	Baseline to Day 20	Change of HbA1c from baseline to Day 20 with SAR425899 or placebo
Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)	20 days	Change of lipid biomarkers over time with SAR425899 or placebo
Pharmacokinetics	Day 16	Assessment of SAR425899: terminal elimination half-life (t1/2)
Total daily energy expenditure	Baseline to Day 19	Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo
Resting energy expenditure	Baseline to Day 19	Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo

Trial Locations

Locations (2)

Investigational Site Number 8400001; 🇺🇸 Orlando, Florida, United States

Investigational Site Number 8400002; 🇺🇸 Baton Rouge, Louisiana, United States