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Recruiting NCT07202884

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

Conditions: Urinary Incontinence,Stress

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1000
Sponsor: Eli Lilly and Company

Location: University of Alabama -The Kirklin Clinic Birmingham Alabama

Summary

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07202884). StuddyBuddy aggregates publicly available trial information.