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

NCT07202884
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,000
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Lead sponsor
Eli Lilly and Company
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Start date
2025-09-30
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Number of sites
136
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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.
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Acronym
RESTRAIN-SUI
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Short title
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
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Official title
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-03-01
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First posted
2025-10-02
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Registry last updated
2026-08-06
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Primary completion date
2028-03-01
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Start date
2025-09-30
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Participants
1,000
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Participant count basis
Estimated
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Planned participants
1,000
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Protocol amendments
0
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Number of sites
136
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07202884
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ClinicalTrials.gov ID
NCT07202884
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Change from Baseline in Incontinence Episode Frequency (IEF)

    Timeframe: Baseline, Week 52

  1. Percent Change from Baseline in Body Weight

    Timeframe: Baseline, Week 52

  2. Change from Baseline in Urinary Incontinence-Specific Quality of Life

    Timeframe: Baseline, Week 52

  3. Change from Baseline in Number of Continence Pad (CAPD) Used Per Week

    Timeframe: Baseline, Week 52

  4. Change from Baseline in Patient Global Impression of Condition

    Timeframe: Baseline, Week 52

  5. Percent Change from Baseline in Total Cholesterol

    Timeframe: Baseline, Week 52

  6. Change from Baseline in Waist Circumference

    Timeframe: Baseline, Week 52

Sources for outcomes
clinicaltrials.gov

Sex
Female
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening
  • Have a diagnosis of stress urinary incontinence

  • Have had urinary incontinence surgery
  • Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence
  • Have given birth within one year of screening
  • Have had a change in body weight of more than 11 pounds within 90 days prior to screening
  • Have used any anti-obesity medication or alternative weight loss remedies within 180 days prior to screening
  • Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
  • Have had a cardiovascular health condition within 90 days prior to screening
  • Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study
Sources for eligibility
clinicaltrials.gov

  • University of Alabama -The Kirklin ClinicBirmingham, United StatesRecruiting
  • AMR ClinicalMobile, United StatesRecruiting
  • Urologic Surgeons of ArizonaMesa, United StatesRecruiting
  • Matrix Clinical ResearchLos Angeles, United StatesRecruiting
  • Alarcon Urology CenterMontebello, United StatesRecruiting
  • Prestige Medical GroupTustin, United StatesCompleted
  • Colorado Clinical ResearchLakewood, United StatesRecruiting
  • AMR ClinicalFort Myers, United StatesRecruiting
  • Altus ResearchLake Worth, United StatesRecruiting
  • New Age Medical Research CorporationMiami, United StatesRecruiting
  • Emerald Coast OBGYN Clinical ResearchPanama City, United StatesRecruiting
  • Teak Research ConsultsLawrenceville, United StatesRecruiting
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United StatesRecruiting
  • OB/GYN Associates of ErieErie, United StatesRecruiting
  • Clinical Research of PhiladelphiaPhiladelphia, United StatesRecruiting
  • Next Level Urgent CareHouston, United StatesRecruiting
  • Innovative Medical Research of TexasHouston, United StatesRecruiting
  • Health Research of Hampton Roads, Inc.Newport News, United StatesRecruiting
  • Urology of VirginiaVirginia Beach, United StatesRecruiting
  • Northwest Clinical Research CenterBellevue, United StatesRecruiting
  • Seattle Clinical Research CenterSeattle, United StatesRecruiting
  • OCT Research ULCKelowna, CanadaRecruiting
  • Kelowna Health and Memory CentreKelowna, CanadaRecruiting
  • Alpha Recherche Clinique - LévisLévis, CanadaRecruiting
  • The Fe/Male Health CentreOakville, CanadaRecruiting

And 111 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522514-23-00
  • J2A-MC-GZPS
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)