NCT07202884RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
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 · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 24 Sept 2025
- Start date
- 30 Sept 2025
- Primary completion date
- Mar 2028
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT07202884
- EU CT number
- 2025-522514-23-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1000
- From 30 Sept 2025 to the primary completion date, Mar 2028
- 119 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (119)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OCT Research ULC Coordinator of this site? Confirm its status | Kelowna | Canada | Recruiting |
| Kelowna Health and Memory Centre Coordinator of this site? Confirm its status | Kelowna | Canada | Recruiting |
| Alpha Recherche Clinique - Lévis Coordinator of this site? Confirm its status | Lévis | Canada | Recruiting |
| The Fe/Male Health Centre Coordinator of this site? Confirm its status | Oakville | Canada | Recruiting |
| Alpha Recherche Clinique Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| CaRe Clinic Coordinator of this site? Confirm its status | Red Deer | Canada | Recruiting |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Chengdu Women and Children Center Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| 2nd Affiliated Hospital Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhujiang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Second Affiliated hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Gansu Provincial Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Obstetrics&Gynecology Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Afimed - Urologicka ambulance Coordinator of this site? Confirm its status | Benešov | Czechia | Active, not recruiting |
| Gynekologie Šottner Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| Centrum Panevniho Dna Coordinator of this site? Confirm its status | Karlovy Vary | Czechia | Active, not recruiting |
| Kestr-gyn Coordinator of this site? Confirm its status | Náchod | Czechia | Active, not recruiting |
| G-CENTRUM Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Active, not recruiting |
| NEUMED gynekologická ambulance Coordinator of this site? Confirm its status | Olomouc | Czechia | Active, not recruiting |
| GYNORD plus Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| Gyncare Coordinator of this site? Confirm its status | Pilsen | Czechia | Active, not recruiting |
| Nestátní zdravotnické zařízení GONA Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Hasegawa Hospital - Arakawa Coordinator of this site? Confirm its status | Arakawa City | Japan | Recruiting |
| Takasu Nephrology and Urology Clinic Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| Yotsuya Medical Cube Coordinator of this site? Confirm its status | Chiyoda City | Japan | Recruiting |
| St. Luke's International Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Recruiting |
| Mito Medical Center Coordinator of this site? Confirm its status | Higashiibaraki | Japan | Recruiting |
| Kokura Memorial Hospital Coordinator of this site? Confirm its status | Kitakyushu | Japan | Recruiting |
| Touyu Clinic Coordinator of this site? Confirm its status | Matsudo | Japan | Recruiting |
| Tokyo Saiseikai Central Hospital Coordinator of this site? Confirm its status | Minatoku | Japan | Recruiting |
| Koujunkai Daido Clinic Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Women's Clinic LUNA NEXT STAGE Coordinator of this site? Confirm its status | Naka-ku, Yokohama-Shi | Japan | Recruiting |
| Chiba Saiseikai Narashino hospital Coordinator of this site? Confirm its status | Narashino | Japan | Recruiting |
| Nakazawa Nephrology and Urology Clinic Coordinator of this site? Confirm its status | Nonoichi | Japan | Recruiting |
| Miyabi Urogyne Clinic Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Nakatsu Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Yukigaya Urology Clinic Coordinator of this site? Confirm its status | Ōta-ku | Japan | Recruiting |
| Kashiwazaki Obstetrics and Gynecology Clinic Coordinator of this site? Confirm its status | Saitama-shi | Japan | Recruiting |
| Izumi Chuo Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Nihon University Itabashi Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Recruiting |
| Toride Urology Clinic Coordinator of this site? Confirm its status | Toride | Japan | Recruiting |
| Tsukuba Urocare Clinic Coordinator of this site? Confirm its status | Tsukuba | Japan | Recruiting |
| Hallym University Sacred Heart Hospital Coordinator of this site? Confirm its status | Anyang-si | South Korea | Recruiting |
| The Catholic University of Korea, Bucheon St. Mary's Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Junggu | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Scientia Investigacion Clinica S.C. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Recruiting |
| Medical Center Metas Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Recruiting |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. Coordinator of this site? Confirm its status | Ciudad Madero | Mexico | Recruiting |
| Health Pharma Querétaro Coordinator of this site? Confirm its status | Juriquilla | Mexico | Recruiting |
| Medical Care and Research Sa de Cv Coordinator of this site? Confirm its status | Mérida | Mexico | Recruiting |
| Clinstile, S.A. de C.V. Coordinator of this site? Confirm its status | México | Mexico | Not yet recruiting |
| RM Pharma Specialists - Unidad Especializada en Datos Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
| Quemex Medical and Research Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
| Centro de Oncología de Precisión - Mexico City Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| Jose Gerardo Garza Leal Coordinator of this site? Confirm its status | Monterrey | Mexico | Not yet recruiting |
| Centro de investigación y control metabólico Coordinator of this site? Confirm its status | Monterrey | Mexico | Recruiting |
| Centro de Investigacion Clinica Chapultepec Coordinator of this site? Confirm its status | Morelia | Mexico | Not yet recruiting |
| Medimanage Research Coordinator of this site? Confirm its status | Tlalpan | Mexico | Recruiting |
| IN VIVO Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Centrum Medyczne Euromedis Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Medical Concierge Centrum Medyczne Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Centrum Medyczne Ginemedica Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| EMC Instytut Medyczny SA Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Spitalul Clinic Judetean de Urgenta Brasov Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Centrul Medical Unirea Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Delta Health Care Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Fundeni Clinical Institute Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Profesor Doctor Theodor Burghele Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colentina Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Gnosis Evomed S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Județean de Urgență Ilfov Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic de Nefrologie Doctor Carol Davila Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul de Urgenta al Ministerului Administratiei si Internelor "Prof. Dr. Dimitrie Gerota" Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Județean de Urgență Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Spitalul Clinic Judetean De Urgenta Bihor Coordinator of this site? Confirm its status | Oradea | Romania | Recruiting |
| Clinica Polisano Coordinator of this site? Confirm its status | Sibiu | Romania | Recruiting |
| Polaris Medical SA Coordinator of this site? Confirm its status | Suceagu | Romania | Recruiting |
| Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Coordinator of this site? Confirm its status | Timisoara | Romania | Recruiting |
| S.C. Materna Care S.R.L. Coordinator of this site? Confirm its status | Timișoara | Romania | Recruiting |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| University of Alabama -The Kirklin Clinic Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| OB/GYN Associates of Erie Coordinator of this site? Confirm its status | Erie | United States | Recruiting |
| AMR Clinical Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| Innovative Medical Research of Texas Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Next Level Urgent Care Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Colorado Clinical Research Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Altus Research Coordinator of this site? Confirm its status | Lake Worth | United States | Recruiting |
| Teak Research Consults Coordinator of this site? Confirm its status | Lawrenceville | United States | Recruiting |
| Matrix Clinical Research Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Urologic Surgeons of Arizona Coordinator of this site? Confirm its status | Mesa | United States | Not yet recruiting |
| New Age Medical Research Corporation Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| AMR Clinical Coordinator of this site? Confirm its status | Mobile | United States | Recruiting |
| Alarcon Urology Center Coordinator of this site? Confirm its status | Montebello | United States | Recruiting |
| Health Research of Hampton Roads, Inc. Coordinator of this site? Confirm its status | Newport News | United States | Recruiting |
| Emerald Coast OBGYN Clinical Research Coordinator of this site? Confirm its status | Panama City | United States | Recruiting |
| Clinical Research of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Completed |
| Seattle Clinical Research Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Coordinator of this site? Confirm its status | Troy | United States | Recruiting |
| Prestige Medical Group Coordinator of this site? Confirm its status | Tustin | United States | Completed |
| Urology of Virginia Coordinator of this site? Confirm its status | Virginia Beach | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.