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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Orforglipron
  • Placebo

Treatment groups

1,000 Participants
are divided into 4 treatment groups

Locations

137
Canada
Kelowna Health and Memory CentreV1Y 5A8, Kelowna Canada
OCT Research ULCV1Y 1Z9, Kelowna Canada
Alpha Recherche Clinique - LévisG6V 0C9, Lévis Canada
The Fe/Male Health CentreL6H 3P1, Oakville Canada

Sponsors and collaborators

Eli Lilly and Company

Lead sponsor