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RESTRAIN-SUINCT07202884

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

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 24 versions: 24 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 136 → 120 locations
  2. Site details revised at 1 of 136 sites
  3. Eligibility criteria expanded, about 10 words
    • Site details revised at 16 of 136 sites
  4. Site details revised at 3 of 136 sitesv21
  5. Study sites: 137 to 136v20
Show 18 earlier versionsHide 18 earlier versions
  1. Site details revised at 1 of 137 sitesv19
  2. Site details revised at 2 of 137 sitesv18
  3. Site details revised at 3 of 137 sitesv17
  4. Study sites: 136 to 137v16
  5. Site details revised at 4 of 136 sitesv15
  6. Site details revised at 14 of 136 sitesv14
  7. Site details revised at 7 of 136 sitesv13
  8. Site details revised at 2 of 136 sitesv12
  9. Study sites: 133 to 136v11
  10. Study sites: 131 to 133v10
  11. Study sites: 129 to 131v9
  12. Study sites: 128 to 129v8
  13. Study sites revised (128)v7
  14. Study sites: 126 to 128v6
  15. Site details revised at 6 of 126 sitesv5
  16. Study sites: 121 to 126v4
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 117 to 121
    • Start date changed from estimate of Oct 2025 to Sep 30, 2025
    v3
  18. Study sites: 115 to 117v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from Baseline in Incontinence Episode Frequency (IEF)
Timeframe: Baseline, Week 52

Secondary (6)

Percent Change from Baseline in Body Weight
Change from Baseline in Urinary Incontinence-Specific Quality of Life
Change from Baseline in Number of Continence Pad (CAPD) Used Per Week
Change from Baseline in Patient Global Impression of Condition
Percent Change from Baseline in Total Cholesterol
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Change from Baseline in Waist Circumference

Arms and interventions

Orforglipron (GZS1)Experimental

Participants will receive orforglipron orally

Placebo (GZS1)Placebo comparator

Participants will receive placebo orally

Orforglipron (GZS2)Experimental

Participants will receive orforglipron orally

Placebo (GZS2)Placebo comparator

Participants will receive placebo orally

Drugs: Orforglipron, Placebo

Sites

120 sites in 9 countries

United States 21, China 20, Japan 20, Romania 16, Mexico 13, Czechia 9, Canada 8, South Korea 7, Poland 6