A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 234
- 主要终点
- Change from Baseline in Incontinence Episode Frequency (IEF)
研究概览
简要总结
The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2. Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity or overweight. SUI is leaking urine during movement or activity such as coughing or exercising. Participation in the study will last about 58 weeks from screening to safety follow-up.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening
- •Have a diagnosis of stress urinary incontinence
排除标准
- •Have had urinary incontinence surgery
- •Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence
- •Have given birth within one year of screening
- •Have had a change in body weight of more than 11 pounds within 90 days prior to screening
- •Have used any anti-obesity medication or alternative weight loss remedies within 180 days prior to screening
- •Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- •Have had a cardiovascular health condition within 90 days prior to screening
- •Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study
研究组 & 干预措施
Placebo (GZS1)
Participants will receive placebo orally
干预措施: Placebo (Drug)
Placebo (GZS2)
Participants will receive placebo orally
干预措施: Placebo (Drug)
Orforglipron (GZS1)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron (GZS2)
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
结局指标
主要结局
Change from Baseline in Incontinence Episode Frequency (IEF)
时间窗: Baseline, Week 52
次要结局
- Percent Change from Baseline in Body Weight(Baseline, Week 52)
- Change from Baseline in Urinary Incontinence-Specific Quality of Life(Baseline, Week 52)
- Change from Baseline in Number of Continence Pad (CAPD) Used Per Week(Baseline, Week 52)
- Change from Baseline in Patient Global Impression of Condition(Baseline, Week 52)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 52)
- Change from Baseline in Waist Circumference(Baseline, Week 52)