Clinical trial NCT03414736: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of gastrointestinal (GI) adverse events (AEs)
timeFrame: Main study: Up to week 8; Six-month study extension period: Up to month 8
measure: Frequency of GI AEs
timeFrame: Main study: Up to week 8; Six-month study extension period: Up to month 8
measure: Frequency of GI AEs
timeFrame: Main study: Up to week 8; Six-month study extension period: Up to month 8
Secondary outcomes:
measure: Change in body weight
timeFrame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
measure: Change in fasting plasma glucose (FPG)
timeFrame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
measure: Adverse events (AEs)
timeFrame: Main study: up to week 8; Six-month extension period: up to month 8
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Investigational Site Number 8400002
state: Minnesota
city: Knoxville
country: United States
facility: Investigational Site Number 8400003
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 8400001
state: Texas
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: