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Clinical Trial Details

Trial ID: L1871
Source ID: NCT03350191
Associated Drug: Sar425899
Title: A Clinical Study to Investigate if SAR425899 Binds to the Liver and Pancreas in Overweight to Obese Type 2 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: SAR425899|DRUG: [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer)|DRUG: [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)
Outcome Measures: Primary: Glucagon receptor occupancy, Change of glucagon receptor tracer binding in the liver with SAR425899 between Day 1 and Day 20, Day 1 and Day 20 | Secondary: GLP-1 receptor occupancy, Change of GLP-1 receptor tracer binding in the pancreas with SAR425899 between Day 1 and Day 17, Day 1 and Day 17|Adverse events, Number of adverse events in patients under treatment with SAR425899, Up to 27 days|Pharmacokinetics, Assessment of SAR425899 maximum plasma concentration (Cmax), Day 20|Change in fasting plasma glucose (FPG), Absolute change in FPG from baseline to Day 20, Day 1 to Day 20|Change in ketone bodies, Absolute change in ketone bodies from baseline to Day 20, Day 1 to Day 20|Change lipid biomarkers, Absolute change cholesterol from baseline to Day 20, Day 1 to Day 20|Change in volume of distribution (Vt) in the liver, Change of glucagon receptor tracer Vt in the liver with SAR425899 between Day 1 and Day 20, Day 1 and Day 20|Change in Vt in the pancreas, Change of GLP-1 receptor tracer Vt in the pancreas with SAR425899 between Day 1 and Day 17, Day 1 and Day 17|Average standard uptake values (SUVs) of PET tracers in the liver and pancreas, Average SUVs for glucagon and GLP-1 tracer in liver and pancreas, Day 1, Day 17 and Day 20|Pharmacokinetics, Assessment of SAR425899 time to reach Cmax ( tmax), Day 20|Pharmacokinetics, Assessment of SAR425899 area under the concentration versus time curve (AUC), Day 20|Pharmacokinetics, Assessment of SAR425899 terminal elimination half-life ( t1/2), Day 20|Pharmacokinetics, Assessment of SAR425899 total body clearance from the plasma (CL), Day 20|Change lipid biomarkers, Absolute change in free fatty acids from baseline to Day 20, Day 1 to Day 20|Change lipid biomarkers, Absolute change in triglycerides from baseline to Day 20, Day 1 to Day 20
Sponsor/Collaborators: Sponsor: Sanofi | Collaborators: Antaros Medical
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2017-12-20
Completion Date: 2018-06-07
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 7520001, Uppsala, 75237, Sweden
URL: https://clinicaltrials.gov/show/NCT03350191