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NCT Number: 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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 8400002, Saint Paul, Minnesota, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR425899

Drug

Pharmaceutical form: Solution

Route of administration: Subcutaneous

Primary outcomes

  1. Frequency of gastrointestinal (GI) adverse events (AEs)

    Time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8

    Relative frequency of GI AEs

  2. Frequency of GI AEs

    Time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8

    Absolute frequency of GI AEs

  3. Frequency of GI AEs

    Time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8

    Severity of GI AEs

Secondary outcomes

  1. Change in body weight

    Time frame: 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.

  2. Change in fasting plasma glucose (FPG)

    Time frame: 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.

  3. Change in hemoglobin A1c (HbA1c)

    Time frame: 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.

  4. Adverse events (AEs)

    Time frame: Main study: up to week 8; Six-month extension period: up to month 8

    Number of AEs

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2018
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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