Clinical Trial

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

Study acronym: RESTRAIN-SUI
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07202884
Lead Sponsor Eli Lilly and Company
Conditions Urinary Incontinence,Stress
Enrollment 1,000 participants
Start Date 2025-09-30
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-17