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A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
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
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the study
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.
What is being tested
- Orforglipron (drug)
- Placebo (drug)
Sponsor: Eli Lilly and Company · Participants: 1,000 · Started: Sep 30, 2025
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 317-615-4559
Official record on ClinicalTrials.gov — NCT07202884
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.