A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT07202884
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Urinary Incontinence,Stress
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Orforglipron — DRUGAdministered orally
- Placebo — DRUGAdministered orally
Study Details
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 Dates
- Start date
- Sep 30, 2025
- Status verified
- Jun 2026
- Primary completion
- Mar 31, 2028
- Completion
- Mar 31, 2028
Study Design
- Enrollment
- 1,000 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Orforglipron (GZS1)Participants will receive orforglipron orally
- Placebo Comparator: Placebo (GZS1)Participants will receive placebo orally
- Experimental: Orforglipron (GZS2)Participants will receive orforglipron orally
- Placebo Comparator: Placebo (GZS2)Participants will receive placebo orally
Primary Outcome Measure
Change from Baseline in Incontinence Episode Frequency (IEF) [ Time Frame: Baseline, Week 52 ]
Central Contacts
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or317-615-4559
- Physicians interested in becoming principal investigators please contact
Locations (21)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama -The Kirklin Clinic | Birmingham | Alabama | 35233 | Gabriela Halder (PRINCIPAL_INVESTIGATOR) |
| AMR Clinical | Mobile | Alabama | 36608 | Danilo Herrera (PRINCIPAL_INVESTIGATOR) |
| Urologic Surgeons of Arizona | Mesa | Arizona | 85206 | Kashif Alvi (PRINCIPAL_INVESTIGATOR) |
| Matrix Clinical Research | Los Angeles | California | 90057 | 310-424-5922 Peyman Banooni (PRINCIPAL_INVESTIGATOR) |
| Alarcon Urology Center | Montebello | California | 90640 | Juan Alarcon (PRINCIPAL_INVESTIGATOR) |
| Prestige Medical Group | Tustin | California | 92780 | Lamia Gabal (PRINCIPAL_INVESTIGATOR) |
| Colorado Clinical Research | Lakewood | Colorado | 80228 | 303-996-9649 David Cahn (PRINCIPAL_INVESTIGATOR) |
| AMR Clinical | Fort Myers | Florida | 33912 | 239-936-4421 Kevin Fleishman (PRINCIPAL_INVESTIGATOR) |
| Altus Research | Lake Worth | Florida | 33461 | 561-641-0404 Samuel Lederman (PRINCIPAL_INVESTIGATOR) |
| New Age Medical Research Corporation | Miami | Florida | 33186 | 305-596-9901 Joanna Bedell (PRINCIPAL_INVESTIGATOR) |
| Emerald Coast OBGYN Clinical Research | Panama City | Florida | 32405 | Samuel Wolf (PRINCIPAL_INVESTIGATOR) |
| Teak Research Consults | Lawrenceville | Georgia | 30043 | Kamar Alabi (PRINCIPAL_INVESTIGATOR) |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | 248-312-0025 Neil Fraser (PRINCIPAL_INVESTIGATOR) |
| OB/GYN Associates of Erie | Erie | Pennsylvania | 16507 | Michael Scutella (PRINCIPAL_INVESTIGATOR) |
| Clinical Research of Philadelphia | Philadelphia | Pennsylvania | 19114 | 215-676-6696 Eugene Andruczyk (PRINCIPAL_INVESTIGATOR) |
| Innovative Medical Research of Texas | Houston | Texas | 77065 | Karyn Cumberbatch (PRINCIPAL_INVESTIGATOR) |
| Next Level Urgent Care | Houston | Texas | 77057 | 832-460-3311 Wilner Jeudy (PRINCIPAL_INVESTIGATOR) |
| Health Research of Hampton Roads, Inc. | Newport News | Virginia | 23606 | 757-591-8100 George Freeman (PRINCIPAL_INVESTIGATOR) |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | Kurt McCammon (PRINCIPAL_INVESTIGATOR) |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | 877-453-0404 Ann Kolwitz (PRINCIPAL_INVESTIGATOR) |
| Seattle Clinical Research Center | Seattle | Washington | 98104 | 206-522-3330 Rebecca Dunsmoor-Su (PRINCIPAL_INVESTIGATOR) |
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