Tests orforglipron tablet in women with stress urinary incontinence and excess weight
Tests orforglipron tablets against placebo in adult women with leaking urine and overweight.
Plain-language title generated from the registry record
Registry title: A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Key facts
- Where
- Arakawa City, Chiba, Chiyoda City, Chūōku, Higashiibaraki, Kitakyushu, Matsudo, Minatoku, Nagoya, Naka-ku, Yokohama-Shi, Narashino, Nonoichi, Okayama, Osaka, Ōta-ku, Saitama-shi, Sendai, tabashi City, Toride, and Tsukuba, JapanSee the 20 sites
- Phase
- Phase 3
Where in Japan
- Hasegawa Hospital - ArakawaArakawa City, JapanTaking people
- Takasu Nephrology and Urology ClinicChiba, JapanTaking people
- Yotsuya Medical CubeChiyoda City, JapanTaking people
- St. Luke's International HospitalChūōku, JapanTaking people
- Mito Medical CenterHigashiibaraki, JapanTaking people
- Kokura Memorial HospitalKitakyushu, JapanTaking people
- Touyu ClinicMatsudo, JapanTaking people
- Tokyo Saiseikai Central HospitalMinatoku, JapanTaking people
- Koujunkai Daido ClinicNagoya, JapanTaking people
- Women's Clinic LUNA NEXT STAGENaka-ku, Yokohama-Shi, JapanTaking people
- Chiba Saiseikai Narashino hospitalNarashino, JapanTaking people
- Nakazawa Nephrology and Urology ClinicNonoichi, JapanTaking people
- Miyabi Urogyne ClinicOkayama, JapanTaking people
- Nakatsu HospitalOsaka, JapanTaking people
- Yukigaya Urology ClinicŌta-ku, JapanTaking people
- Kashiwazaki Obstetrics and Gynecology ClinicSaitama-shi, JapanTaking people
- Izumi Chuo HospitalSendai, JapanTaking people
- Nihon University Itabashi Hospitaltabashi City, JapanTaking people
- Toride Urology ClinicToride, JapanTaking people
- Tsukuba Urocare ClinicTsukuba, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07202884EU 2025-522514-23-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Have had urinary incontinence surgery; Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence; 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 had a cardiovascular health condition within 90 days prior to screening; Have type 1 diabetes, type 2 diabetes, or any other type of diabetes; Have given birth within one year of screening; Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study.