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
Female Urogenital Diseases and Pregnancy Complications
Decision date
26/01/2026
Enrollment target
295
Sites
Romania, Czechia, Poland
Condition studied
Urinary Incontinence, Stress
Investigational medicinal product(s)
OrforglipronOrforglipronOrforglipronOrforglipronOrforglipronPlacebo to match lyOrforglipron
Eligibility
Age group
18-64 years
Sex
Female
Primary endpoint
Change from Baseline in Incontinence Episode Frequency (IEF)
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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