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

Study acronym: RESTRAIN-SUI
StatusRecruiting
PhasePhase 3
Started2025-09-30
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 20 times since 2025-09-24; most recent filed 2026-09-04. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-09-15.

2026-09-04
Amendment Study Status, Contacts/Locations v20
2026-08-05
Amendment Study Status, Contacts/Locations v19
2026-07-16
Amendment Study Status, Contacts/Locations v18
2026-06-19
Amendment Study Status, Contacts/Locations v17
2026-06-03
Amendment Study Status, Contacts/Locations v16
2026-05-20
Amendment Study Status, Contacts/Locations v15
2026-05-13
Amendment Study Status, Contacts/Locations v14
2026-04-16
Amendment Study Status, Contacts/Locations v13
2026-03-19
Amendment Study Status, Contacts/Locations v12
2026-03-06
Amendment Study Status, Contacts/Locations v11
2026-02-27
Amendment Study Status, Contacts/Locations v10
2026-02-09
Amendment Study Status, Contacts/Locations v9
2026-01-16
Amendment Study Status, Contacts/Locations v8
2026-01-12
Amendment Study Status, Contacts/Locations v7
2025-12-23
Amendment Study Status, Contacts/Locations v6
2025-12-05
Amendment Study Status, Contacts/Locations v5
2025-11-19
Amendment Study Status, Contacts/Locations v4
2025-11-03
Amendment Study Status, Contacts/Locations v3
2025-10-15
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations, References v2
2025-10-08
Amendment Study Status, Contacts/Locations v1
2025-09-24
Original filing
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 2026-09-08