What this trial means for you
This study is recruiting now at 21 US sites. It's studying Orforglipron, Placebo for urinary incontinence,stress.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Alabama
- University of Alabama -The Kirklin Clinic — Birmingham · Recruiting now
- AMR Clinical — Mobile · Recruiting now
Arizona
- Urologic Surgeons of Arizona — Mesa · Recruiting now
California
- Matrix Clinical Research — Los Angeles · Recruiting now
- Alarcon Urology Center — Montebello · Recruiting now
- Prestige Medical Group — Tustin · Recruiting now
Colorado
- Colorado Clinical Research — Lakewood · Recruiting now
Florida
- AMR Clinical — Fort Myers · Recruiting now
- Altus Research — Lake Worth · Recruiting now
- New Age Medical Research Corporation — Miami · Recruiting now
- Emerald Coast OBGYN Clinical Research — Panama City · Recruiting now
Georgia
- Teak Research Consults — Lawrenceville · Recruiting now
Michigan
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy · Recruiting now
Pennsylvania
- OB/GYN Associates of Erie — Erie · Recruiting now
- Clinical Research of Philadelphia — Philadelphia · Recruiting now
Texas
- Next Level Urgent Care — Houston · Recruiting now
- Innovative Medical Research of Texas — Houston · Recruiting now
Virginia
- Health Research of Hampton Roads, Inc. — Newport News · Recruiting now
- Urology of Virginia — Virginia Beach · Recruiting now
Washington
- Northwest Clinical Research Center — Bellevue · Recruiting now
- Seattle Clinical Research Center — Seattle · Recruiting now
View the official record on ClinicalTrials.gov →
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