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

NCT07202884

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Urinary Incontinence,Stress

Interventions: Orforglipron, Placebo

Countries: United States, Canada, China, Czechia, India, Japan, Mexico, Poland

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (136)
  • Birmingham, Alabama, United States
  • Mobile, Alabama, United States
  • Mesa, Arizona, United States
  • Los Angeles, California, United States
  • Montebello, California, United States
  • Tustin, California, United States
  • Lakewood, Colorado, United States
  • Fort Myers, Florida, United States
  • Lake Worth, Florida, United States
  • Miami, Florida, United States
  • Panama City, Florida, United States
  • Lawrenceville, Georgia, United States
  • Troy, Michigan, United States
  • Erie, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Newport News, Virginia, United States
  • Virginia Beach, Virginia, United States
  • Bellevue, Washington, United States
  • Seattle, Washington, United States
  • Kelowna, Canada
  • Kelowna, Canada
  • Lévis, Canada
  • Oakville, Canada
  • Québec, Canada
  • Québec, Canada
  • Red Deer, Canada
  • Toronto, Canada
  • Beijing, China
  • + 106 more on CT.gov