Orforglipron for Stress Urinary Incontinence in Overweight Women
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Recruiting
Phase 3Interventional Study
Urinary Incontinence,Stress
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for overweight or obese women who experience stress urinary incontinence, which means leaking urine during activities like coughing or exercising. If you join, you will participate for about 58 weeks, with regular check-ups to monitor your health and safety.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesType 2 diabetes
You may be able to join if
I have a body mass index (BMI) of 27 or higher.
I have been diagnosed with stress urinary incontinence.
You may not be able to join if
I have had urinary incontinence surgery.
I have received Botox bladder injections recently.
I have given birth in the past year.
I have had a significant weight change of more than 11 pounds recently.
I have used anti-obesity medications or weight loss remedies recently.
I have diabetes.
I have had a heart condition in the past 90 days.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 t…
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.
Trial Locations
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Status
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 …
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
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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