A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight

What this study is about

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 join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• University of Alabama -The Kirklin Clinic, Birmingham, Alabama, United States
• AMR Clinical, Mobile, Alabama, United States
• Urologic Surgeons of Arizona, Mesa, Arizona, United States
• Matrix Clinical Research, Los Angeles, California, United States
• Alarcon Urology Center, Montebello, California, United States
• Prestige Medical Group, Tustin, California, United States
• Colorado Clinical Research, Lakewood, Colorado, United States
• AMR Clinical, Fort Myers, Florida, United States
• Altus Research, Lake Worth, Florida, United States
• New Age Medical Research Corporation, Miami, Florida, United States
• Emerald Coast OBGYN Clinical Research, Panama City, Florida, United States
• Teak Research Consults, Lawrenceville, Georgia, United States

+ 124 more sites.

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 317-615-4559 · LillyTrials@Lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07202884.