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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult women who leak urine during activity such as coughing or exercise (stress urinary incontinence) and who have obesity or overweight.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Diagnosis of stress urinary incontinence
- Earlier treatment
- Cannot join if they had urinary incontinence surgery, recent Botox bladder injections, or any anti-obesity medication or alternative weight loss remedies within 180 days before screening. Cannot join if they currently take medicines for urinary incontinence.
- Biomarker or test result
- Body mass index (BMI) of 27 kg/m2 or higher at screening
Main reasons for not taking part
- Type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Gave birth within one year of screening
- Body weight change of more than 11 pounds (5 kg) within 90 days before screening
- A cardiovascular health condition within 90 days before screening
- Pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed during the study
Read by machine on 12 November 2026.
Where in Japan
- Hasegawa Hospital - ArakawaArakawa City, JapanContact: Hiroyuki Shimizu (principal investigator)Taking people
- Takasu Nephrology and Urology ClinicChiba, JapanContact: Takeshi Shichijo (principal investigator)Taking people
- Yotsuya Medical CubeChiyoda City, JapanContact: shimoinaba misa (principal investigator)Taking people
- St. Luke's International HospitalChūōku, JapanContact: Kazutaka Narimoto (principal investigator)Taking people
- Mito Medical CenterHigashiibaraki, JapanContact: Masahiro Iinuma (principal investigator)Taking people
- Kokura Memorial HospitalKitakyushu, JapanContact: Shigeru Sakano (principal investigator)Taking people
- Touyu ClinicMatsudo, JapanContact: Masahiko Suzuki (principal investigator)Taking people
- Tokyo Saiseikai Central HospitalMinatoku, JapanContact: Hiroki Ide (principal investigator)Taking people
- Koujunkai Daido ClinicNagoya, JapanContact: Hiroyuki Kamiya (principal investigator)Taking people
- Women's Clinic LUNA NEXT STAGENaka-ku, Yokohama-Shi, JapanContact: YUKI SEKIGUCHI (principal investigator)Taking people
- Chiba Saiseikai Narashino hospitalNarashino, JapanContact: Kazuo Mikami (principal investigator)Taking people
- Nakazawa Nephrology and Urology ClinicNonoichi, JapanContact: Yusuke Nakazawa (principal investigator)Taking people
- Miyabi Urogyne ClinicOkayama, JapanContact: Miyabi Inoue (principal investigator)Taking people
- Nakatsu HospitalOsaka, JapanContact: Hirofumi Uehara (principal investigator)Taking people
- Yukigaya Urology ClinicŌta-ku, JapanContact: Ken Miyama (principal investigator)Taking people
- Kashiwazaki Obstetrics and Gynecology ClinicSaitama-shi, JapanContact: Yuji Kashiwazaki (principal investigator)Taking people
- Izumi Chuo HospitalSendai, JapanContact: Haruo Nakagawa (principal investigator)Taking people
- Nihon University Itabashi Hospitaltabashi City, JapanContact: Tsuyoshi Yoshizawa (principal investigator)Taking people
- Toride Urology ClinicToride, JapanContact: YUKIHIDE MATSUI (principal investigator)Taking people
- Tsukuba Urocare ClinicTsukuba, JapanContact: Tingwen Huang (principal investigator)Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.