Orforglipron for Stress Incontinence
(RESTRAIN-SUI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests orforglipron, a new medication, to determine its effectiveness for women with stress urinary incontinence (SUI) who are also overweight or have obesity. SUI causes urine leakage during activities like coughing or exercising. The trial aims to assess the treatment's efficacy and safety. Women who have not undergone surgery for urinary incontinence and have a BMI of 27 or higher may qualify for this study. Participants will be involved for about 58 weeks, including follow-up for safety. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
If you are currently taking medications for urinary incontinence, you will need to stop them to participate in this trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that orforglipron has a safety record similar to other GLP-1 medications, commonly used for diabetes and weight management. In earlier studies, most participants tolerated orforglipron well, experiencing no serious side effects. Common reactions included mild stomach issues and headaches, typical for this type of medication.
Orforglipron is currently being tested for stress urinary incontinence in individuals who are overweight or have obesity. Its safety has already been studied, providing reassurance. The progression to this testing stage indicates that earlier trials did not identify major safety problems. It is important to consult healthcare professionals with any concerns or questions.12345Why do researchers think this study treatment might be promising for stress incontinence?
Unlike the standard treatments for stress incontinence, which often include pelvic floor exercises, medications like anticholinergics, or surgical options, Orforglipron offers a novel approach. This drug is an oral treatment that works by targeting specific hormonal pathways to improve bladder control. Researchers are excited because Orforglipron has the potential to offer a more convenient and non-invasive option with fewer side effects compared to existing therapies. Its unique mechanism of action could provide a significant improvement in quality of life for those struggling with stress incontinence.
What evidence suggests that orforglipron might be an effective treatment for stress incontinence?
This trial will evaluate the effectiveness of orforglipron, a once-daily pill, for managing stress urinary incontinence (SUI) in women who are overweight or obese. Participants will receive either orforglipron or a placebo. Studies have shown that orforglipron, part of the GLP-1 receptor agonists group, effectively helps control blood sugar and weight in other conditions. In other trials, orforglipron significantly improved blood sugar levels, which may aid in weight management, an important factor in SUI. Early findings suggest that orforglipron could reduce SUI symptoms, offering new hope for those dealing with this condition. While more research is needed specifically for SUI, the drug's mechanism and early success in related areas are encouraging signs.13467
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adult women with stress urinary incontinence, which means they leak urine during activities like coughing or exercising. Participants should be overweight or have obesity. The study will last about 58 weeks from screening to follow-up.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive orforglipron or placebo orally to assess efficacy and safety in treating stress urinary incontinence
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Orforglipron
Trial Overview
The study is testing the effectiveness and safety of a drug called Orforglipron compared to a placebo (a substance with no active drug). It's part of two independent studies under the GZPS master protocol focusing on women with SUI and weight issues.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive orforglipron orally
Participants will receive orforglipron orally
Participants will receive placebo orally
Participants will receive placebo orally
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
NCT07202884 | A Study of Orforglipron in Female ...
Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity or overweight.
2.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/35371007/eli-lillys-new-study-on-orforglipron-a-potential-game-changer-for-stress-urinary-incontinence/Eli Lilly's New Study on Orforglipron: A Potential Game ...
The study aims to evaluate the effectiveness and safety of Orforglipron in treating stress urinary incontinence (SUI) in overweight or obese ...
A Study of Orforglipron in Female Participants With Stress ...
Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity ...
4.
docwirenews.com
docwirenews.com/post/orforglipron-phase-3-data-dr-michael-weintraub-reviews-attain-1-and-achieve-1-findingsOrforglipron Phase 3 Data: Dr. Michael Weintraub Reviews ...
Dr. Michael A. Weintraub, of NYU Langone, reviews phase 3 data from the ATTAIN-1 and ACHIEVE-1 trials of orforglipron, a once-daily oral ...
5.
investor.lilly.com
investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statisticallyLilly's oral GLP-1, orforglipron, demonstrated statistically ...
Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses.
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-orforglipron-in-female-participants-with-stress-urinary-incontinence-who-have-obesity-orA Study of Orforglipron in Female Participants With Stress ...
SUI is leaking urine during movement or activity such as coughing or exercising. Participation in the study will last about 58 weeks from ...
Orforglipron: Uses, Interactions, Mechanism of Action
Orforglipron is under investigation in clinical trial NCT06010004 (A Long-term Safety Study of Orforglipron (LY3502970) in Participants With ...
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