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A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight (RESTRAIN-SUI)
EU CTIS ID: 2025-522514-23-00
What this study is testing
To demonstrate orforglipron is superior to placebo in the change in weekly incontinence episode frequency.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Have a body mass index that indicates obesity or overweight
- Have a diagnosis of stress urinary incontinence
You likely can't join if
- Have given birth within one year of screening
- Have had urinary incontinence surgery or other types of surgeries
- Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence
- Have gained or lost more than 11 pounds within 90 days prior to screening
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Have had a heart condition within 90 days prior to screening
See the full eligibility criteria
- Have a body mass index that indicates obesity or overweight
- Have a diagnosis of stress urinary incontinence
- Have given birth within one year of screening
- Have had urinary incontinence surgery or other types of surgeries
- Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence
- Have gained or lost more than 11 pounds within 90 days prior to screening
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Have had a heart condition within 90 days prior to screening
- Have used any weight loss medication or alternative remedies within 180 days prior to screening
- Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study
The study team makes the final eligibility decision.
Where it's taking place
- India
- Japan
- Canada
- Mexico
- Korea, Republic of
- China
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; Japan; Canada; Mexico; Korea, Republic of; China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.