J2A-MC-GZPS: 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 (RESTRAIN-SUI) ; J2A-MC-GZS1: A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants with Stress Urinary Incontinence Who Have Obesity or Overweight ; J2A-MC-GZS2: A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants with Stress Urinary Incontinence Who Have Obesity or Overweight

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522514-23-00

Acronym

J2A-MC-GZPS

Enrollment

160

Registered

2026-01-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Stress

Brief summary

Change from Baseline in Incontinence Episode Frequency (IEF)

Interventions

DRUGOrforglipron

DRUGPlacebo to match ly

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Incontinence Episode Frequency (IEF)	—

Countries

Czechia, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026