A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety and Tolerability of Aleniglipron in Adult Participants With Type 2 Diabetes Mellitus Living With Obesity or Overweight
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
- 试验地点
- 16
- 主要终点
- Incidence, severity and relationship of AEs/SAEs
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 240 mg once daily (QD) in participants with T2DM who are living with obesity (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •A diagnosis of T2DM of ≥6 months,
- •Hemoglobin A1c (HbA1c) ≥6.5% to ≤10% at Screening
- •Have a BMI ≥27.0 kg/m2
排除标准
- •Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. All participants must have a photo fundoscopy, optical coherence tomography, or slit lamp assessment prior to randomization and within the last 12 months to confirm the absence or stable status of diabetic retinopathy and/or macular edema.
- •Present or planned use of any drug that could interfere with glucose levels
- •Self-reported change in body weight >5 kg (11 pounds) within 3 months before screening
- •Have prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to Screening)
- •Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening, including, but not limited to, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal endoluminal liner
研究组 & 干预措施
Arm 1: Participants will receive aleniglipron administered orally
Drug aleniglipron administered orally
干预措施: Aleniglipron (Drug)
Arm 2: Participants will receive a placebo administered orally
Drug placebo administered orally
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence, severity and relationship of AEs/SAEs
时间窗: Baseline to week 31
Assessment of vital signs
时间窗: Baseline to week 31
Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.
Assessment of laboratory measures
时间窗: Baseline to week 31
Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters: including hematology, serum chemistry, coagulation
Assessment of Electrocardiograms (ECG)
时间窗: Baseline to week 31
Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to: ventricular heart rate, PR interval, QRS duration, QT interval, and QTcF
Incidence, severity and relationship of AEs/SAEs
时间窗: Baseline to week 38
Assessment of vital signs
时间窗: Baseline to week 38
Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.
Assessment of laboratory measures
时间窗: Baseline to week 38
Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters: including hematology, serum chemistry, coagulation
Assessment of Electrocardiograms (ECG)
时间窗: Baseline to week 38
Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to: ventricular heart rate, PR interval, QRS duration, QT interval, and QTcF
次要结局
- PK parameters including but not limited to Cmax(Baseline to week 30)
- Absolute change in body weight from Baseline(Baseline to week 31)
- Percent change in body weight from Baseline(Baseline to week 31)
- Change in HbA1c from Baseline(Baseline to week 30)
- Change in fasting plasma glucose from Baseline(Baseline to week 31)
- PK parameters including but not limited to AUC(Baseline to week 30)
- PK parameters including but not limited to Tmax(Baseline to week 30)
- PK parameters including but not limited to Ctrough(Baseline to week 30)
- Absolute change in body weight from Baseline(Baseline to week 39)
- Percent change in body weight from Baseline(Baseline to week 39)
- Change in HbA1c from Baseline(Baseline to week 39)
- Change in fasting plasma glucose from Baseline(Baseline to week 39)
- PK parameters including but not limited to AUC(Baseline to week 39)
- PK parameters including but not limited to Cmax(Baseline to week 39)
- TPK parameters including but not limited to Tmax(Baseline to week 39)
- PK parameters including but not limited to Ctrough(Baseline to week 39)