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
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 sc…
Interventions
- DrugOrforglipron
Administered orally
- DrugPlacebo
Administered orally
Locations (136)
- University of Alabama -The Kirklin ClinicBirmingham, Alabama
- AMR ClinicalMobile, Alabama
- Urologic Surgeons of ArizonaMesa, Arizona
- Matrix Clinical ResearchLos Angeles, California
- Alarcon Urology CenterMontebello, California
- Prestige Medical GroupTustin, California