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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Frequency of gastrointestinal (GI) adverse events (AEs)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.
干预措施: SAR425899 (Drug)
Cohort 2
Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.
干预措施: SAR425899 (Drug)
Cohort 3
Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.
干预措施: SAR425899 (Drug)
结局指标
主要结局
Frequency of gastrointestinal (GI) adverse events (AEs)
时间窗: Main study: Up to week 8; Six-month study extension period: Up to month 8
Relative frequency of GI AEs
Frequency of GI AEs
时间窗: Main study: Up to week 8; Six-month study extension period: Up to month 8
Severity of GI AEs
次要结局
- Change in body weight(Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8)
- 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 hemoglobin A1c (HbA1c)(Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8)
- Adverse events (AEs)(Main study: up to week 8; Six-month extension period: up to month 8)