> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-orforglipron-in-female-participants-with-stress-bd49c874-ba85-4495-8f83-63015cd0f57f > Record changed: 2026-10-13 # A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight NCT07202884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) Participants 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) Start date 2025-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) Number of sites 136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Acronym** RESTRAIN-SUI Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Short title** A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Dates **Completion date** 2028-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **First posted** 2025-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Registry last updated** 2026-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Primary completion date** 2028-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Start date** 2025-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Size and sites **Participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Planned participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Number of sites** 136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Identifiers **Registry ID** NCT07202884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **ClinicalTrials.gov ID** NCT07202884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Outcomes ### Primary outcomes 1. Change from Baseline in Incontinence Episode Frequency (IEF) Timeframe: Baseline, Week 52 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/658355) ### Other registry identifiers (3) - 2025 - 2025-522514-23-00 - J2A-MC-GZPS Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07202884) ## Related records ### Drugs (1) - [Orforglipron](https://trialight.com/data/asset/orforglipron-1138c12b-f1c7-45bb-b9ec-2b693f019a62.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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