Primary Objective: To assess in healthy adult male subjects: * The tolerability and safety of 21-day repeated subcutaneous (SC) doses of SAR425899 including two up titration steps. * Pharmacokinetic (PK) parameters of SAR425899 after ascending repeated SC doses in plasma. * Pharmacodynamic (PD) effects on fasting and postprandial plasma glucose, insulin, biomarkers of lipid metabolism and fibroblast growth factor 21 (FGF21). To assess in overweight to obese T2DM mellitus patients: * The tolerability and safety after 28-day repeated SC doses of SAR425899 including 2 up titration steps. * PK parameters of SAR425899 after ascending repeated SC doses in plasma and urine. * PD effects on fasting and postprandial plasma glucose, insulin, C-peptide, incretin panel (total and active ghrelin, total peptide YY \[PYY\], total and active glucagon-like peptide -1 \[GLP-1\], glucagon and total gastric inhibitory polypeptide-1 \[GIP\]), body weight, FGF21, biomarkers of lipid metabolism and HbA1c.
The total study duration is approximately 10-15 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
76
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: tablet Route of administration: oral
Investigational Site Number 276001
Berlin, Germany
Number of adverse events
Time frame: 28 to 35 days
Changes in vital signs
Time frame: 28 to 35 days
Changes in physical examination
Time frame: 28 to 35 days
Changes in ECG
Time frame: 28 to 35 days
Changes in clinical laboratory parameters (hematology)
Time frame: 28 to 35 days
Changes in clinical laboratory parameters (biochemistry)
Time frame: 28 to 35 days
Changes in body temperature
Time frame: 28 to 35 days
Change from baseline in biomarkers (FGF21)
Time frame: 28 to 35 days
Change from baseline in biomarkers (lipid biomarker)
Time frame: 28 to 35 days
Change from baseline in biomarkers (incretins)
Time frame: 28 to 35 days
Assessment of pharmacokinetic parameters in blood (AUC)
Time frame: 28 to 35 days
Assessment of pharmacokinetic parameters in blood (Cmax)
Time frame: 28 to 35 days
Assessment of pharmacokinetic parameters in blood (t1/2)
Time frame: 28 to 35 days
Assessment of pharmacokinetic parameters in urine (Ae0-24)
Time frame: 28 to 35 days
Assessment of pharmacokinetic parameters in urine (fe0-24)
Time frame: 28 to 35 days
Change from baseline in Body weight
Time frame: 28 to 35 days
Change from baseline in Fasting Blood Glucose
Time frame: 28 to 35 days
Change from baseline in Postprandial Blood Glucose
Time frame: 28 to 35 days
Change from baseline in postprandial Insulin
Time frame: 28 to 35 days
Change from baseline in postprandial C-peptide profiles
Time frame: 28 to 35 days
Change from baseline in HbA1c
Time frame: 28 to 35 days
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