Orforglipron for Stress Incontinence

(RESTRAIN-SUI Trial)

Recruiting at 126 trial locations

Overseen By Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Urinary incontinence medications

Disqualifiers: Diabetes, Cardiovascular conditions, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

1000 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

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

Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening

I have been diagnosed with stress urinary incontinence.

Exclusion Criteria

Have given birth within one year of screening

I have diabetes.

Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orforglipron or placebo orally to assess efficacy and safety in treating stress urinary incontinence

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

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?

Group I: Orforglipron (GZS2) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group II: Orforglipron (GZS1) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group III: Placebo (GZS2) Placebo Group 1 Intervention

Participants will receive placebo orally

Group IV: Placebo (GZS1) Placebo Group 1 Intervention

Participants will receive placebo orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07202884

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 ...

3. trialx.com trialx.com/clinical-trials/listings/325270/a-study-of-orforglipron-in-female-participants-with-stress-urinary-incontinence-who-have-obesity-or-overweight/?&radius=10&place=Putzu&user_country=Taiwan

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-findings

Orforglipron 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-statistically

Lilly'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-or

A 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 ...

7. go.drugbank.com go.drugbank.com/drugs/DB18964

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 ...