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
Status: Recruiting
Location: See all (127) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama -The Kirklin Clinic
RECRUITING
Birmingham
AMR Clinical
RECRUITING
Mobile
Arizona
Urologic Surgeons of Arizona
RECRUITING
Mesa
California
Matrix Clinical Research
RECRUITING
Los Angeles
Alarcon Urology Center
RECRUITING
Montebello
Prestige Medical Group
RECRUITING
Tustin
Colorado
Colorado Clinical Research
RECRUITING
Lakewood
Florida
AMR Clinical
RECRUITING
Fort Myers
Altus Research
RECRUITING
Lake Worth
New Age Medical Research Corporation
RECRUITING
Miami
Emerald Coast OBGYN Clinical Research
RECRUITING
Panama City
Georgia
Teak Research Consults
RECRUITING
Lawrenceville
Michigan
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
RECRUITING
Troy
Pennsylvania
OB/GYN Associates of Erie
RECRUITING
Erie
Clinical Research of Philadelphia
RECRUITING
Philadelphia
Texas
Innovative Medical Research of Texas
RECRUITING
Houston
Next Level Urgent Care
RECRUITING
Houston
Virginia
Health Research of Hampton Roads, Inc.
RECRUITING
Newport News
Urology of Virginia
RECRUITING
Virginia Beach
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Seattle Clinical Research Center
RECRUITING
Seattle
Other Locations
Canada
Kelowna Health and Memory Centre
RECRUITING
Kelowna
OCT Research ULC
RECRUITING
Kelowna
Alpha Recherche Clinique - Lévis
RECRUITING
Lévis
The Fe/Male Health Centre
RECRUITING
Oakville
Alpha Recherche Clinique
RECRUITING
Québec
ALPHA Recherche Clinique
RECRUITING
Québec
CaRe Clinic
RECRUITING
Red Deer
Sunnybrook Research Institute
RECRUITING
Toronto
China
Peking University First Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
Chengdu Women and Children Center Hospital
RECRUITING
Chengdu
2nd Affiliated Hospital Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital of Jinan University
RECRUITING
Guangzhou
Zhujiang Hospital
RECRUITING
Guangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Second Affiliated hospital of Anhui Medical University
RECRUITING
Hefei
Gansu Provincial Hospital
RECRUITING
Lanzhou
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Ningbo First Hospital
RECRUITING
Ningbo
Obstetrics & Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University
RECRUITING
Xiamen
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
India
Apollo Hospitals Ahmedabad
NOT_YET_RECRUITING
Ahmedabad
Devasya Superspeciality Kidney & Multispeciality Hospitals
NOT_YET_RECRUITING
Ahmedabad
KLES Dr. Prabhakar Kore Hospital & M.R.C
NOT_YET_RECRUITING
Belagavi
Belagavi Institute of Medical Sciences - Belagavi
NOT_YET_RECRUITING
Belgavi
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Bhubaneswar
Postgraduate Institute of Medical Education & Research
NOT_YET_RECRUITING
Chandigarh
Apollo Hospitals - Chennai
NOT_YET_RECRUITING
Chennai
Malla Reddy Narayana Multispeciality Hospital
NOT_YET_RECRUITING
Hyderabad
Ketki Nursing Home & Urology Hospital
NOT_YET_RECRUITING
Nagpur
Sir Ganga Ram Hospital
NOT_YET_RECRUITING
New Delhi
Lifepoint Multispeciality Hospital
NOT_YET_RECRUITING
Pune
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Raipur
All India Institute of Medical Sciences - Rishikesh
NOT_YET_RECRUITING
Rishikesh
Surat Institute of Digestive Sciences Hospitals
NOT_YET_RECRUITING
Surat
Banaras Hindu University
NOT_YET_RECRUITING
Varanasi
Japan
Hasegawa Hospital - Arakawa
RECRUITING
Arakawa City
Takasu Nephrology and Urology Clinic
NOT_YET_RECRUITING
Chiba
Yotsuya Medical Cube
RECRUITING
Chiyoda City
St. Luke's International Hospital
NOT_YET_RECRUITING
Chūōku
Mito Medical Center
RECRUITING
Higashiibaraki
Nihon University Itabashi Hospital
NOT_YET_RECRUITING
Itabashiku
Kokura Memorial Hospital
RECRUITING
Kitakyushu
Touyu Clinic
NOT_YET_RECRUITING
Matsudo
Tokyo Saiseikai Central Hospital
RECRUITING
Minatoku
Koujunkai Daido Clinic
RECRUITING
Nagoya
Women's Clinic LUNA NEXT STAGE
RECRUITING
Naka-ku, Yokohama-shi
Chiba Saiseikai Narashino hospital
NOT_YET_RECRUITING
Narashino
Nakazawa Nephrology and Urology Clinic
RECRUITING
Nonoichi
Miyabi Urogyne Clinic
RECRUITING
Okayama
Nakatsu Hospital
NOT_YET_RECRUITING
Osaka
Yukigaya Urology Clinic
RECRUITING
Ōta-ku
Kashiwazaki Obstetrics and Gynecology Clinic
NOT_YET_RECRUITING
Saitama-shi
Izumi Chuo Hospital
NOT_YET_RECRUITING
Sendai
Toride Urology Clinic
NOT_YET_RECRUITING
Toride
Tsukuba Urocare Clinic
RECRUITING
Tsukuba
Mexico
Medical Center Metas
NOT_YET_RECRUITING
Chihuahua City
Scientia Investigacion Clinica S.C.
NOT_YET_RECRUITING
Chihuahua City
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
NOT_YET_RECRUITING
Ciudad Madero
Health Pharma Querétaro
NOT_YET_RECRUITING
Juriquilla
Medical Care and Research SA de CV
NOT_YET_RECRUITING
Mérida
Clinstile, S.A. de C.V.
NOT_YET_RECRUITING
México
Centro de Oncología de Precisión - Mexico City
NOT_YET_RECRUITING
Mexico City
Quemex Medical and Research
NOT_YET_RECRUITING
Mexico City
RM Pharma Specialists - Unidad Especializada en Datos
NOT_YET_RECRUITING
Mexico City
Centro de investigación y control metabólico
NOT_YET_RECRUITING
Monterrey
Jose Gerardo Garza Leal
NOT_YET_RECRUITING
Monterrey
Centro de Investigacion Clinica Chapultepec
NOT_YET_RECRUITING
Morelia
Medimanage Research
NOT_YET_RECRUITING
Tlalpan
Poland
IN VIVO
RECRUITING
Bydgoszcz
AIDPORT Sp. z o.o.
RECRUITING
Skórzewo
Centrum Medyczne Euromedis
RECRUITING
Szczecin
Medical Concierge Centrum Medyczne
RECRUITING
Warsaw
Centrum Medyczne Ginemedica
RECRUITING
Wroclaw
EMC Instytut Medyczny SA
RECRUITING
Wroclaw
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang-si
The Catholic University of Korea, Bucheon St. Mary's Hospital
RECRUITING
Bucheon-si
Pusan National University Hospital
RECRUITING
Busan
Chonnam National University Hospital
RECRUITING
Gwangju
Kyungpook National University Hospital
RECRUITING
Junggu
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Romania
Centrul Medical Unirea
NOT_YET_RECRUITING
Brasov
Spitalul Clinic Judetean de Urgenta (Brasov)
RECRUITING
Brasov
Delta Health Care
RECRUITING
Bucharest
Fundeni Clinical Institute
RECRUITING
Bucharest
Gnosis Evomed S.R.L.
RECRUITING
Bucharest
Spitalul Clinic Colentina
RECRUITING
Bucharest
Spitalul Clinic de Nefrologie Doctor Carol Davila
RECRUITING
Bucharest
Spitalul Clinic Județean de Urgență Ilfov
RECRUITING
Bucharest
Spitalul Clinic Profesor Doctor Theodor Burghele
RECRUITING
Bucharest
Spitalul de Urgenta al Ministerului Administratiei si Internelor Prof. Dr. Dimitrie Gerota
RECRUITING
Bucharest
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
NOT_YET_RECRUITING
Bucharest
Spitalul Clinic Județean de Urgență
RECRUITING
Craiova
Spitalul Clinic Judetean De Urgenta Bihor
NOT_YET_RECRUITING
Oradea
Clinica Polisano
NOT_YET_RECRUITING
Sibiu
Polaris Medical SA
RECRUITING
Suceagu
S.C. Materna Care S.R.L.
RECRUITING
Timișoara
Spitalul Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara
RECRUITING
Timișoara
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2028-03
Participants
Target number of participants: 1000
Treatments
Experimental: Orforglipron (GZS1)
Participants will receive orforglipron orally
Placebo_comparator: Placebo (GZS1)
Participants will receive placebo orally
Experimental: Orforglipron (GZS2)
Participants will receive orforglipron orally
Placebo_comparator: Placebo (GZS2)
Participants will receive placebo orally
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company