Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5019
Source ID: NCT03376802
Associated Drug: Sar425899
Title: A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: SAR425899|DRUG: Placebo
Outcome Measures: 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|Resting energy expenditure, Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo, Baseline to Day 19|Basal energy expenditure, Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo, Baseline to Day 19|Respiratory quotient (RQ), Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo, Baseline to Day 19|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|Diet Induced Thermogenesis (DIT), Change of DIT from baseline to Day 19 with SAR425899 or placebo, Baseline to Day 19|Fasting plasma glucose, Change of FPG over time with SAR425899 or placebo, 20 days|HbA1c, Change of HbA1c from baseline to Day 20 with SAR425899 or placebo, Baseline to Day 20|Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol), Change of lipid biomarkers over time with SAR425899 or placebo, 20 days|Ketone bodies, Change of ketone bodies over time with SAR425899 or placebo, 20 days|Adverse events, Number of adverse events in patients under treatment with SAR425899 or placebo, Up to 27 days|Pharmacokinetics, Assessment of SAR425899: time to reach Cmax (tmax), Day 16|Pharmacokinetics, Assessment of SAR425899: maximum plasma concentration (Cmax), Day 16|Pharmacokinetics, Assessment of SAR425899: area under the concentration versus time curve (AUC), Day 16|Pharmacokinetics, Assessment of SAR425899: terminal elimination half-life (t1/2), Day 16
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2018-04-18
Completion Date: 2018-12-27
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 8400001, Orlando, Florida, 32804, United States|Investigational Site Number 8400002, Baton Rouge, Louisiana, 70808, United States
URL: https://clinicaltrials.gov/show/NCT03376802