A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Orforglipron, Placebo.
- Who it may be relevant to
- Registry conditions: Urinary Incontinence,Stress. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, China, Czechia, India +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Orforglipron
Administered orally - Drug Placebo
Administered orally
Primary outcome measures
- Change from Baseline in Incontinence Episode Frequency (IEF) [Time frame: Baseline, Week 52]
Secondary outcome measures (6)
- Percent Change from Baseline in Body Weight [Time frame: Baseline, Week 52]
- Change from Baseline in Urinary Incontinence-Specific Quality of Life [Time frame: Baseline, Week 52]
- Change from Baseline in Number of Continence Pad (CAPD) Used Per Week [Time frame: Baseline, Week 52]
- Change from Baseline in Patient Global Impression of Condition [Time frame: Baseline, Week 52]
- Percent Change from Baseline in Total Cholesterol [Time frame: Baseline, Week 52]
- Change from Baseline in Waist Circumference [Time frame: Baseline, Week 52]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- University of Alabama -The Kirklin Clinic — Birmingham
- AMR Clinical — Mobile
- Urologic Surgeons of Arizona — Mesa
- Matrix Clinical Research — Los Angeles
- Alarcon Urology Center — Montebello
- Prestige Medical Group — Tustin
- Colorado Clinical Research — Lakewood
- AMR Clinical — Fort Myers
- … and 13 more centers
China · 21 centers
- Peking University People's Hospital — Beijing
- Xuanwu Hospital Capital Medical University — Beijing
- Peking University Third Hospital — Beijing
- Peking University First Hospital — Beijing
- Sichuan Provincial People's Hospital — Chengdu
- Chengdu Women and Children Center Hospital — Chengdu
- 2nd Affiliated Hospital Chongqing Medical University — Chongqing
- Zhujiang Hospital — Guangzhou
- … and 13 more centers
Japan · 20 centers
- Hasegawa Hospital - Arakawa — Arakawa City
- Takasu Nephrology and Urology Clinic — Chiba
- Yotsuya Medical Cube — Chiyoda City
- St. Luke's International Hospital — Chūōku
- Mito Medical Center — Higashiibaraki
- Nihon University Itabashi Hospital — Itabashiku
- … and 14 more centers
Romania · 16 centers
Center list to be confirmed — check the primary protocol.
India · 15 centers
- Devasya Superspeciality Kidney & Multispeciality Hospitals — Ahmedabad
- Apollo Hospitals Ahmedabad — Ahmedabad
- KLES Dr. Prabhakar Kore Hospital & M.R.C — Belagavi
- Belagavi Institute of Medical Sciences - Belagavi — Belgavi
- All India Institute of Medical Sciences — Bhubaneswar
- Postgraduate Institute of Medical Education & Research — Chandigarh
- Apollo Hospitals - Chennai — Chennai
- Malla Reddy Narayana Multispeciality Hospital — Hyderabad
- … and 7 more centers
Mexico · 13 centers
Center list to be confirmed — check the primary protocol.
Czechia · 9 centers
- Afimed - Urologicka ambulance — Benešov
- Gynekologie Šottner — Brno
- Centrum Panevniho Dna — Karlovy Vary
- Kestr-gyn — Náchod
- G-CENTRUM Olomouc — Olomouc
- NEUMED gynekologická ambulance — Olomouc
- GYNORD plus — Ostrava
- Gyncare — Pilsen
- … and 1 more center
Canada · 8 centers
- OCT Research ULC — Kelowna
- Kelowna Health and Memory Centre — Kelowna
- Alpha Recherche Clinique - Lévis — Lévis
- The Fe/Male Health Centre — Oakville
- Alpha Recherche Clinique — Québec
- ALPHA Recherche Clinique — Québec
- CaRe Clinic — Red Deer
- Sunnybrook Research Institute — Toronto
South Korea · 7 centers
Center list to be confirmed — check the primary protocol.
Poland · 6 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07202884 · 27672 · 2025-522514-23-00 · J2A-MC-GZPS · J2A-MC-GZS1 · J2A-MC-GZS2