Status:
RECRUITING
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Lead Sponsor:
Eli Lilly and Company
Conditions:
Urinary Incontinence,Stress
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07202884
Start Date
September 30 2025
End Date
March 1 2028
Last Update
December 24 2025
Active Locations (128)
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1
University of Alabama -The Kirklin Clinic
Birmingham, Alabama, United States, 35233
2
AMR Clinical
Mobile, Alabama, United States, 36608
3
Urologic Surgeons of Arizona
Mesa, Arizona, United States, 85206
4
Matrix Clinical Research
Los Angeles, California, United States, 90057