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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Urinary Incontinence,Stress

In brief

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.

Key facts

Study ID

NCT07202884

Run by

Eli Lilly and Company

People needed

1000

Starts

2025-09-30

Expected to finish

2028-03-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• AMR Clinical — Mobile, Alabama, United States (enrolling)
• University of Alabama -The Kirklin Clinic — Birmingham, Alabama, United States (enrolling)
• Matrix Clinical Research — Los Angeles, California, United States (enrolling)
• Alarcon Urology Center — Montebello, California, United States (enrolling)
• Urologic Surgeons of Arizona — Mesa, Arizona, United States (enrolling)
• Colorado Clinical Research — Lakewood, Colorado, United States (enrolling)
• AMR Clinical — Fort Myers, Florida, United States (enrolling)
• Altus Research — Lake Worth, Florida, United States (enrolling)
• New Age Medical Research Corporation — Miami, Florida, United States (enrolling)
• Emerald Coast OBGYN Clinical Research — Panama City, Florida, United States (enrolling)
• Teak Research Consults — Lawrenceville, Georgia, United States (enrolling)
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States (enrolling)
• OB/GYN Associates of Erie — Erie, Pennsylvania, United States (enrolling)
• Clinical Research of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Next Level Urgent Care — Houston, Texas, United States (enrolling)
• Innovative Medical Research of Texas — Houston, Texas, United States (enrolling)
• Health Research of Hampton Roads, Inc. — Newport News, Virginia, United States (enrolling)
• Urology of Virginia — Virginia Beach, Virginia, United States (enrolling)
• Northwest Clinical Research Center — Bellevue, Washington, United States (enrolling)
• Seattle Clinical Research Center — Seattle, Washington, United States (enrolling)
• OCT Research ULC — Kelowna, Canada (enrolling)
• Kelowna Health and Memory Centre — Kelowna, Canada (enrolling)
• Alpha Recherche Clinique - Lévis — Lévis, Canada (enrolling)
• The Fe/Male Health Centre — Oakville, Canada (enrolling)
• Alpha Recherche Clinique — Québec, Canada (enrolling)

Full record on ClinicalTrials.gov

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