Trials / Recruiting
RecruitingNCT07202884
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Orforglipron | Administered orally |
| DRUG | Placebo | Administered orally |
Timeline
- Start date
- 2025-09-30
- Primary completion
- 2028-03-01
- Completion
- 2028-03-01
- First posted
- 2025-10-02
- Last updated
- 2026-04-17
Locations
136 sites across 10 countries: United States, Canada, China, Czechia, India, Japan, Mexico, Poland, Romania, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07202884. Inclusion in this directory is not an endorsement.