A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3,600
- 试验地点
- 71
- 主要终点
- Percent change in body weight from Baseline
研究概览
简要总结
Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.
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
- •BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
排除标准
- •Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
- •Self-reported change in body weight >5 kg within 3 months before Screening.
- •Have prior or planned surgical or non-surgical treatment for obesity.
- •Have or plan to have endoscopic and/or device-based therapy for obesity.
- •Have obesity induced by other endocrine disorders.
- •Impaired renal function at Screening
- •Chronic malabsorption
研究组 & 干预措施
aleniglipron Arm 3
Participants will receive aleniglipron administered orally.
干预措施: Aleniglipron (Drug)
Placebo Arm 4
Participants will receive placebo administered orally.
干预措施: Placebo (Drug)
aleniglipron Arm 1
Participants will receive aleniglipron administered orally.
干预措施: Aleniglipron (Drug)
aleniglipron Arm 2
Participants will receive aleniglipron administered orally.
干预措施: Aleniglipron (Drug)
结局指标
主要结局
Percent change in body weight from Baseline
时间窗: Baseline and Week 76
次要结局
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline(Baseline and week 76)
- Change in resting systolic blood pressure from Baseline(Baseline and week 76)
- Change in waist circumference from Baseline(Baseline and week 76)
- Percent change in fasting triglycerides and non-HDL cholesterol from Baseline(Baseline and week 76)
- Change in HbA1c from Baseline(Baseline and week 76)
- Change in body mass index from Baseline(Baseline and week 76)
- Percent change in fasting total cholesterol from Baseline(Baseline and week 76)
- Change in fasting glucose from Baseline(Baseline and week 76)
- Change in resting diastolic blood pressure from Baseline(Baseline and week 76)
- Change in body weight (absolute) from Baseline(Baseline and week 76)
- Percentage of participants who achieve ≥5% reduction in body weight(Baseline and week 76)
- Percentage of participants who achieve ≥10% reduction in body weight(Baseline and week 76)
- Percentage of participants who achieve ≥15% reduction in body weight(Baseline and week 76)
- Percentage of participants who achieve ≥20% reduction in body weight(Baseline and week 76)