The Purpose of This Study is to Learn About the Safety and Effectiveness of Berobenatide in Women With Urine Leakage and With Obesity or Overweight
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BEROBENATIDE IN ADULT FEMALE PARTICIPANTS WITH STRESS URINARY INCONTINENCE AND WITH OBESITY OR OVERWEIGHT (VESPER-SUI)
The purpose of this study is to learn about the safety and effectiveness of berobenatide in adult women who have both stress urinary incontinence (SUI) and obesity or overweight.
Participants will be in the study for about 63 weeks
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Pfizer CT.gov Call Center
- 电话号码：1-800-718-1021
- 邮箱：ClinicalTrials.gov_Inquiries@pfizer.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult women aged 18 years or older
- Body mass index (BMI) of 27 kg/m² or greater
- Have a diagnosis of stress urinary incontinence
- Willing and able to comply with study procedures
Exclusion Criteria:
- Have had urinary incontinence surgery
- Have taken medications (prescribed or over-the counter) intended to promote weight loss within 90 days prior to randomization
- Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence
- History of acute or chronic pancreatitis
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2)
- Have diabetes or laboratory assessments indicative of diabetes
- Have had a cardiovascular health condition within 90 days prior to randomization
- Are breastfeeding, pregnant, parturition in the past 12 months, planning to become pregnant in the following 12 months, or of childbearing potential and not using adequate contraception
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Arm 1
Participants will receive Berobenatide administered according to the study dosing regimen |
Berobenatide administered by subcutaneous injection
其他名称：
|
|
安慰剂比较：Arm 2
Participants will receive placebo administered according to the study dosing regimen |
Placebo administered by subcutaneous injection |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change From Baseline in Stress Incontinence Episode Frequency (IEF)
大体时间：Baseline, Week 52
|
Baseline, Week 52
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Percent Change From Baseline in Body Weight
大体时间：Baseline, Week 52
|
Baseline, Week 52
|
|
Number of participants with Treatment-Emergent Adverse Event (TEAE)
大体时间：Week 52
|
Week 52
|
|
Percent change from baseline in Stress Incontinence Episode Frequency
大体时间：Baseline, Week 52
|
Baseline, Week 52
|
|
Change from Baseline in Urinary Incontinence-Specific Quality of Life as assessed by the Quality-of-Life Instrument (QOL)
大体时间：Baseline, Week 52
|
Baseline, Week 52
|
|
Change from Baseline in Fasting Lipids
大体时间：Baseline, Week 52
|
Baseline, Week 52
|
|
Change From Baseline in weight
大体时间：Baseline, Week 52
|
Baseline, Week 52
|
|
Change From Baseline in waist circumference
大体时间：Baseline, Week 52
|
Baseline, Week 52
|
合作者和调查者
赞助
调查人员
- 研究主任：Pfizer CT.gov Call Center、Pfizer
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- C6491036
- 2026-526623-22-00 (注册表标识符：CTIS (EU))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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