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

Completed · Phase 1

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03414736

Run by

Sanofi

People needed

60

Starts

2018-01-19

Expected to finish

2018-10-05

Last updated by the study team

2022-04-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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