Primary Objectives: * Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs). * Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs. Secondary Objectives: Main study and 6-month study extension period: To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy: * The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c). * Safety and tolerability.
Main study: The maximum study duration is approximately 12 weeks per patient (up-to 3-week screening period, 8-week treatment period, 3-day post treatment follow-up period). Six-month study extension period: The maximum study duration is approximately 9 months (up-to 3-week screening period, 8-month treatment period, 3-day post treatment follow-up period).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Pharmaceutical form: Solution Route of administration: Subcutaneous
Investigational Site Number 8400002
Saint Paul, Minnesota, United States
Investigational Site Number 8400003
Knoxville, Tennessee, United States
Investigational Site Number 8400001
Austin, Texas, United States
Frequency of gastrointestinal (GI) adverse events (AEs)
Relative frequency of GI AEs
Time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8
Frequency of GI AEs
Absolute frequency of GI AEs
Time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8
Frequency of GI AEs
Severity of GI AEs
Time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8
Change in body weight
Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
Time frame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
Change in fasting plasma glucose (FPG)
Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
Time frame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
Change in hemoglobin A1c (HbA1c)
Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
Time frame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
Adverse events (AEs)
Number of AEs
Time frame: Main study: up to week 8; Six-month extension period: up to month 8
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