A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity … (NCT07202884) | Clinical Trial Compass
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
United States, Canada, China1,000 participantsStarted 2025-09-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Incontinence Episode Frequency (IEF)
Timeframe: Baseline, Week 52
Trial details
NCT IDNCT07202884
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-03
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or