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A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight

RecruitingPhase 3Ages 18 Years - anyFemaleEli Lilly and Company
NCT07202884 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Orforglipron
  • Placebo
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Where

136 sites
University of Alabama -The Kirklin Clinic
Birmingham, United States
AMR Clinical
Mobile, United States
Urologic Surgeons of Arizona
Mesa, United States
Matrix Clinical Research
Los Angeles, United States
Alarcon Urology Center
Montebello, United States
Prestige Medical Group
Tustin, United States
Colorado Clinical Research
Lakewood, United States
AMR Clinical
Fort Myers, United States

…and 128 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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