A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period

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).

• SAR425899 (Drug): Pharmaceutical form: Solution Route of administration: Subcutaneous

Primary outcomes

• Frequency of gastrointestinal (GI) adverse events (AEs) [Main study: Up to week 8; Six-month study extension period: Up to month 8]: Relative frequency of GI AEs
• Frequency of GI AEs [Main study: Up to week 8; Six-month study extension period: Up to month 8]: Absolute frequency of GI AEs
• Frequency of GI AEs [Main study: Up to week 8; Six-month study extension period: Up to month 8]: Severity of GI AEs

Secondary outcomes

• Change in body weight [Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8]: Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
• Change in fasting plasma glucose (FPG) [Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8]: Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
• Change in hemoglobin A1c (HbA1c) [Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8]: Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
• Adverse events (AEs) [Main study: up to week 8; Six-month extension period: up to month 8]: Number of AEs

Sex: All, ages: 18 Years to 75 Years

Inclusion criteria:

* Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.
* Patients who are motivated to lose weight.

Exclusion criteria:

* Type 1 diabetes mellitus.
* Body mass index <27 kg/m2.
* Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) >7.0%.
* Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.
* Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.
* Uncontrolled hypertension.
* Laboratory findings at the time of screening: amylase and/or lipase >2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase >1.5 ULN, total bilirubin >1.5 ULN, serum creatinine levels ≥1.5 mg/dL \[males\]. ≥1.4 mg/dL \[females\], screening calcitonin ≥20 pmol/m, fasting serum triglycerides >400 mg/dL.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
* History of weight loss surgery.
* History of pancreatitis or pancreatectomy.
* Pregnant or lactating women.
* Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Clinical Sciences & Operations, Study director, Sanofi