Clinical trial
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Recruiting now · Phase 3 · 4 countries · Registry ID NCT07202884
Recruiting nowPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexFemale
Healthy volunteersNot accepted
ConditionUrinary Incontinence,Stress
Full registry criteria
Inclusion Criteria: * 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 Criteria: * Have had urinary incontinence surgery * Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence * Have given birth within one year of screening * 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 type 1 diabetes, type 2 diabetes, or any other type of diabetes * Have had a cardiovascular health condition within 90 days prior to screening * Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study
Treatments and study arms
Orforglipron
Drug
Administered orally
Placebo
Drug
Administered orally
Primary outcomes
Change from Baseline in Incontinence Episode Frequency (IEF)Baseline, Week 52
Study locations
136 locations were listed when this page was built. The first 40 are shown.
OCT Research ULC🇨🇦 Kelowna, Canada
Study contactContact
Mallory MyersPrincipal Investigator
Alpha Recherche Clinique - Lévis🇨🇦 Lévis, Canada
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Steeve Kwan TatPrincipal Investigator
The Fe/Male Health Centre🇨🇦 Oakville, Canada
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Richard CaseyPrincipal Investigator
ALPHA Recherche Clinique🇨🇦 Québec, Canada
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Camille WalshPrincipal Investigator
CaRe Clinic🇨🇦 Red Deer, Canada
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Josias BadenhorstPrincipal Investigator
Xuanwu Hospital Capital Medical University🇨🇳 Beijing, China
Shijun WangPrincipal Investigator
2nd Affiliated Hospital Chongqing Medical University🇨🇳 Chongqing, China
Lina HuPrincipal Investigator
The First Affiliated Hospital of Jinan University🇨🇳 Guangzhou, China
Yuan ShenPrincipal Investigator
Second Affiliated hospital of Anhui Medical University🇨🇳 Hefei, China
Study contactContact
dexin yuPrincipal Investigator
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School🇨🇳 Nanjing, China
Hongqian GuoPrincipal Investigator
Ningbo First Hospital🇨🇳 Ningbo, China
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Qi MaPrincipal Investigator
Obstetrics & Gynecology Hospital of Fudan University🇨🇳 Shanghai, China
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Xiaofang YiPrincipal Investigator
The Second Affiliated Hospital of Soochow University🇨🇳 Suzhou, China
Weipei ZhuPrincipal Investigator
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology🇨🇳 Wuhan, China
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Xiaoyi YuanPrincipal Investigator
The First Affiliated Hospital of Xi'an Jiaotong University🇨🇳 Xi'an, China
Xudong LiPrincipal Investigator
The First Affiliated hospital of Xiamen University🇨🇳 Xiamen, China
Qionghua ChenPrincipal Investigator
General Hospital of Ningxia Medical University🇨🇳 Yinchuan, China
Chunfang HaPrincipal Investigator
Afimed - Urologicka ambulance🇨🇿 Benešov, Czechia
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Ales FialaPrincipal Investigator
Centrum Panevniho Dna🇨🇿 Karlovy Vary, Czechia
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Vladimir KalisPrincipal Investigator
Kestr-gyn🇨🇿 Náchod, Czechia
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Jan KestranekPrincipal Investigator
G-CENTRUM Olomouc🇨🇿 Olomouc, Czechia
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Ales SkrivanekPrincipal Investigator
GYNORD plus🇨🇿 Ostrava, Czechia
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Martina Vortelova BaricakovaPrincipal Investigator
Gyncare🇨🇿 Pilsen, Czechia
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Michael SvecPrincipal Investigator
Nestátní zdravotnické zařízení GONA🇨🇿 Prague, Czechia
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Lukas HorcickaPrincipal Investigator
Devasya Superspeciality Kidney & Multispeciality Hospitals🇮🇳 Ahmedabad, India
Dinesh PatelPrincipal Investigator