Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (119)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
OCT Research ULC
Coordinator of this site? Confirm its status
KelownaCanadaRecruiting
Kelowna Health and Memory Centre
Coordinator of this site? Confirm its status
KelownaCanadaRecruiting
Alpha Recherche Clinique - Lévis
Coordinator of this site? Confirm its status
LévisCanadaRecruiting
The Fe/Male Health Centre
Coordinator of this site? Confirm its status
OakvilleCanadaRecruiting
Alpha Recherche Clinique
Coordinator of this site? Confirm its status
QuébecCanadaRecruiting
CaRe Clinic
Coordinator of this site? Confirm its status
Red DeerCanadaRecruiting
Sunnybrook Research Institute
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Xuanwu Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Peking University Third Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Peking University People's Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Peking University First Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Chengdu Women and Children Center Hospital
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
Sichuan Provincial People's Hospital
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
2nd Affiliated Hospital Chongqing Medical University
Coordinator of this site? Confirm its status
ChongqingChinaRecruiting
The First Affiliated Hospital of Jinan University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Zhujiang Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Zhejiang Provincial People's Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Second Affiliated hospital of Anhui Medical University
Coordinator of this site? Confirm its status
HefeiChinaRecruiting
Gansu Provincial Hospital
Coordinator of this site? Confirm its status
LanzhouChinaRecruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Ningbo First Hospital
Coordinator of this site? Confirm its status
NingboChinaRecruiting
Obstetrics&Gynecology Hospital of Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Peking University Shenzhen Hospital
Coordinator of this site? Confirm its status
ShenzhenChinaRecruiting
The Second Affiliated Hospital of Soochow University
Coordinator of this site? Confirm its status
SuzhouChinaRecruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
The First Affiliated hospital of Xiamen University
Coordinator of this site? Confirm its status
XiamenChinaRecruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Coordinator of this site? Confirm its status
Xi’anChinaRecruiting
Afimed - Urologicka ambulance
Coordinator of this site? Confirm its status
BenešovCzechiaActive, not recruiting
Gynekologie Šottner
Coordinator of this site? Confirm its status
BrnoCzechiaActive, not recruiting
Centrum Panevniho Dna
Coordinator of this site? Confirm its status
Karlovy VaryCzechiaActive, not recruiting
Kestr-gyn
Coordinator of this site? Confirm its status
NáchodCzechiaActive, not recruiting
G-CENTRUM Olomouc
Coordinator of this site? Confirm its status
OlomoucCzechiaActive, not recruiting
NEUMED gynekologická ambulance
Coordinator of this site? Confirm its status
OlomoucCzechiaActive, not recruiting
GYNORD plus
Coordinator of this site? Confirm its status
OstravaCzechiaActive, not recruiting
Gyncare
Coordinator of this site? Confirm its status
PilsenCzechiaActive, not recruiting
Nestátní zdravotnické zařízení GONA
Coordinator of this site? Confirm its status
PragueCzechiaActive, not recruiting
Hasegawa Hospital - Arakawa
Coordinator of this site? Confirm its status
Arakawa CityJapanRecruiting
Takasu Nephrology and Urology Clinic
Coordinator of this site? Confirm its status
ChibaJapanRecruiting
Yotsuya Medical Cube
Coordinator of this site? Confirm its status
Chiyoda CityJapanRecruiting
St. Luke's International Hospital
Coordinator of this site? Confirm its status
ChūōkuJapanRecruiting
Mito Medical Center
Coordinator of this site? Confirm its status
HigashiibarakiJapanRecruiting
Kokura Memorial Hospital
Coordinator of this site? Confirm its status
KitakyushuJapanRecruiting
Touyu Clinic
Coordinator of this site? Confirm its status
MatsudoJapanRecruiting
Tokyo Saiseikai Central Hospital
Coordinator of this site? Confirm its status
MinatokuJapanRecruiting
Koujunkai Daido Clinic
Coordinator of this site? Confirm its status
NagoyaJapanRecruiting
Women's Clinic LUNA NEXT STAGE
Coordinator of this site? Confirm its status
Naka-ku, Yokohama-ShiJapanRecruiting
Chiba Saiseikai Narashino hospital
Coordinator of this site? Confirm its status
NarashinoJapanRecruiting
Nakazawa Nephrology and Urology Clinic
Coordinator of this site? Confirm its status
NonoichiJapanRecruiting
Miyabi Urogyne Clinic
Coordinator of this site? Confirm its status
OkayamaJapanRecruiting
Nakatsu Hospital
Coordinator of this site? Confirm its status
OsakaJapanRecruiting
Yukigaya Urology Clinic
Coordinator of this site? Confirm its status
Ōta-kuJapanRecruiting
Kashiwazaki Obstetrics and Gynecology Clinic
Coordinator of this site? Confirm its status
Saitama-shiJapanRecruiting
Izumi Chuo Hospital
Coordinator of this site? Confirm its status
SendaiJapanRecruiting
Nihon University Itabashi Hospital
Coordinator of this site? Confirm its status
tabashi CityJapanRecruiting
Toride Urology Clinic
Coordinator of this site? Confirm its status
TorideJapanRecruiting
Tsukuba Urocare Clinic
Coordinator of this site? Confirm its status
TsukubaJapanRecruiting
Hallym University Sacred Heart Hospital
Coordinator of this site? Confirm its status
Anyang-siSouth KoreaRecruiting
The Catholic University of Korea, Bucheon St. Mary's Hospital
Coordinator of this site? Confirm its status
Bucheon-siSouth KoreaRecruiting
Pusan National University Hospital
Coordinator of this site? Confirm its status
BusanSouth KoreaRecruiting
Chonnam National University Hospital
Coordinator of this site? Confirm its status
GwangjuSouth KoreaRecruiting
Kyungpook National University Hospital
Coordinator of this site? Confirm its status
JungguSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Scientia Investigacion Clinica S.C.
Coordinator of this site? Confirm its status
Chihuahua CityMexicoRecruiting
Medical Center Metas
Coordinator of this site? Confirm its status
Chihuahua CityMexicoRecruiting
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Coordinator of this site? Confirm its status
Ciudad MaderoMexicoRecruiting
Health Pharma Querétaro
Coordinator of this site? Confirm its status
JuriquillaMexicoRecruiting
Medical Care and Research Sa de Cv
Coordinator of this site? Confirm its status
MéridaMexicoRecruiting
Clinstile, S.A. de C.V.
Coordinator of this site? Confirm its status
MéxicoMexicoNot yet recruiting
RM Pharma Specialists - Unidad Especializada en Datos
Coordinator of this site? Confirm its status
Mexico CityMexicoRecruiting
Quemex Medical and Research
Coordinator of this site? Confirm its status
Mexico CityMexicoRecruiting
Centro de Oncología de Precisión - Mexico City
Coordinator of this site? Confirm its status
Mexico CityMexicoNot yet recruiting
Jose Gerardo Garza Leal
Coordinator of this site? Confirm its status
MonterreyMexicoNot yet recruiting
Centro de investigación y control metabólico
Coordinator of this site? Confirm its status
MonterreyMexicoRecruiting
Centro de Investigacion Clinica Chapultepec
Coordinator of this site? Confirm its status
MoreliaMexicoNot yet recruiting
Medimanage Research
Coordinator of this site? Confirm its status
TlalpanMexicoRecruiting
IN VIVO
Coordinator of this site? Confirm its status
BydgoszczPolandRecruiting
Aidport sp z o.o.
Coordinator of this site? Confirm its status
SkorzewoPolandRecruiting
Centrum Medyczne Euromedis
Coordinator of this site? Confirm its status
SzczecinPolandRecruiting
Medical Concierge Centrum Medyczne
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Centrum Medyczne Ginemedica
Coordinator of this site? Confirm its status
WroclawPolandRecruiting
EMC Instytut Medyczny SA
Coordinator of this site? Confirm its status
WroclawPolandRecruiting
Spitalul Clinic Judetean de Urgenta Brasov
Coordinator of this site? Confirm its status
BrasovRomaniaRecruiting
Centrul Medical Unirea
Coordinator of this site? Confirm its status
BrasovRomaniaRecruiting
Delta Health Care
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Fundeni Clinical Institute
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic Profesor Doctor Theodor Burghele
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic Colentina
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Gnosis Evomed S.R.L.
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic Județean de Urgență Ilfov
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic de Nefrologie Doctor Carol Davila
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul de Urgenta al Ministerului Administratiei si Internelor "Prof. Dr. Dimitrie Gerota"
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic Județean de Urgență
Coordinator of this site? Confirm its status
CraiovaRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Bihor
Coordinator of this site? Confirm its status
OradeaRomaniaRecruiting
Clinica Polisano
Coordinator of this site? Confirm its status
SibiuRomaniaRecruiting
Polaris Medical SA
Coordinator of this site? Confirm its status
SuceaguRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Coordinator of this site? Confirm its status
TimisoaraRomaniaRecruiting
S.C. Materna Care S.R.L.
Coordinator of this site? Confirm its status
TimișoaraRomaniaRecruiting
Northwest Clinical Research Center
Coordinator of this site? Confirm its status
BellevueUnited StatesRecruiting
University of Alabama -The Kirklin Clinic
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
OB/GYN Associates of Erie
Coordinator of this site? Confirm its status
ErieUnited StatesRecruiting
AMR Clinical
Coordinator of this site? Confirm its status
Fort MyersUnited StatesRecruiting
Innovative Medical Research of Texas
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Next Level Urgent Care
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Colorado Clinical Research
Coordinator of this site? Confirm its status
LakewoodUnited StatesRecruiting
Altus Research
Coordinator of this site? Confirm its status
Lake WorthUnited StatesRecruiting
Teak Research Consults
Coordinator of this site? Confirm its status
LawrencevilleUnited StatesRecruiting
Matrix Clinical Research
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Urologic Surgeons of Arizona
Coordinator of this site? Confirm its status
MesaUnited StatesNot yet recruiting
New Age Medical Research Corporation
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
AMR Clinical
Coordinator of this site? Confirm its status
MobileUnited StatesRecruiting
Alarcon Urology Center
Coordinator of this site? Confirm its status
MontebelloUnited StatesRecruiting
Health Research of Hampton Roads, Inc.
Coordinator of this site? Confirm its status
Newport NewsUnited StatesRecruiting
Emerald Coast OBGYN Clinical Research
Coordinator of this site? Confirm its status
Panama CityUnited StatesRecruiting
Clinical Research of Philadelphia
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesCompleted
Seattle Clinical Research Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Coordinator of this site? Confirm its status
TroyUnited StatesRecruiting
Prestige Medical Group
Coordinator of this site? Confirm its status
TustinUnited StatesCompleted
Urology of Virginia
Coordinator of this site? Confirm its status
Virginia BeachUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.