Tests orforglipron tablet in women with stress urinary incontinence and excess weight
Tests orforglipron tablets against placebo in adult women with leaking urine and overweight.
Plain-language title generated from the registry record
Registry title: A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Key facts
- Where
- Brasov, Bucharest, Craiova, Oradea, Sibiu, Suceagu, Timisoara, and Timișoara, RomaniaSee the 16 sites
- Phase
- Phase 3
Where in Romania
- Centrul Medical UnireaBrasov, RomaniaTaking people
- Spitalul Clinic Judetean de Urgenta BrasovBrasov, RomaniaTaking people
- Delta Health CareBucharest, RomaniaTaking people
- Fundeni Clinical InstituteBucharest, RomaniaTaking people
- Gnosis Evomed S.R.L.Bucharest, RomaniaTaking people
- Spitalul Clinic ColentinaBucharest, RomaniaTaking people
- Spitalul Clinic de Nefrologie Doctor Carol DavilaBucharest, RomaniaTaking people
- Spitalul Clinic Județean de Urgență IlfovBucharest, RomaniaTaking people
- Spitalul Clinic Profesor Doctor Theodor BurgheleBucharest, RomaniaTaking people
- Spitalul de Urgenta al Ministerului Administratiei si Internelor "Prof. Dr. Dimitrie Gerota"Bucharest, RomaniaTaking people
- Spitalul Clinic Județean de UrgențăCraiova, RomaniaTaking people
- Spitalul Clinic Judetean De Urgenta BihorOradea, RomaniaTaking people
- Clinica PolisanoSibiu, RomaniaTaking people
- Polaris Medical SASuceagu, RomaniaTaking people
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu TimisoaraTimisoara, RomaniaTaking people
- S.C. Materna Care S.R.L.Timișoara, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07202884EU 2025-522514-23-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Have type 1 diabetes, type 2 diabetes, or any other type of diabetes; 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.