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
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/28/2018 |
| Start Date: | January 19, 2018 |
| End Date: | October 5, 2018 |
A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy, With an Optional 6-month Safety Extension Period
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: 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).
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).
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.
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials