Orforglipron for stress urinary incontinence in women with obesity or overweight

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What is this study about?

This clinical trial studies stress urinary incontinence, a condition where urine leaks during physical activities such as coughing, sneezing, laughing, or exercising. This type of incontinence occurs when the muscles that support the bladder and control urine release become weakened. The study focuses specifically on women who also have obesity or are overweight, as excess body weight can place additional pressure on the bladder and pelvic muscles, potentially worsening incontinence symptoms.

The trial investigates whether a medication called Orforglipron, taken as a tablet once daily by mouth, can help reduce the number of incontinence episodes experienced each week. Orforglipron belongs to a class of medications known as GLP-1 receptor agonists, which work by mimicking a natural hormone in the body that helps regulate appetite and body weight. By potentially helping participants lose weight, this medication may also reduce pressure on the bladder and improve incontinence symptoms. Some participants will receive placebo instead of the active medication.

The study aims to determine if Orforglipron is more effective than placebo in decreasing the frequency of urinary leakage episodes. Participants will take one tablet daily throughout the treatment period, and their incontinence episodes will be monitored and recorded. This is a Phase 3 trial sponsored by Eli Lilly, designed to evaluate both the effectiveness and safety of the medication in this specific patient population.

1 Screening and baseline assessment

The participant undergoes initial health evaluations to confirm eligibility for the study.

Medical history is reviewed, and a physical examination is performed.

The participant’s body mass index (BMI) is measured to confirm obesity or overweight status.

A diagnosis of stress urinary incontinence is confirmed through medical assessment.

Baseline measurements of incontinence episode frequency are recorded.

2 Randomization and treatment assignment

The participant is randomly assigned to receive either Orforglipron tablets or placebo.

The assignment is done by chance, similar to flipping a coin, and neither the participant nor the study team knows which treatment is received.

Instructions are provided on how to take the medication properly.

3 Daily medication administration

The participant takes one Orforglipron tablet or placebo once daily by mouth.

The tablet should be taken at approximately the same time each day.

The medication is taken orally with water.

4 Regular study visits and monitoring

The participant attends scheduled clinic visits throughout the study period.

At each visit, the number of incontinence episodes experienced during the previous week is recorded.

Weight and other health measurements are monitored.

Any side effects or changes in health are reported to the study team.

5 Ongoing treatment period

The participant continues taking the assigned medication daily for the duration of the treatment period.

Regular assessments of incontinence episode frequency continue throughout this phase.

The study team monitors the participant’s progress and overall health.

6 End of treatment and final assessment

The participant completes the final dose of study medication.

A comprehensive final evaluation is conducted to assess the change in incontinence symptoms.

Final measurements are compared to baseline to determine treatment effectiveness.

Follow-up instructions are provided as needed.

Who Can Join the Study?

  • Must be female
  • Must be an adult (18 years of age or older)
  • Must have a body mass index (BMI) that indicates obesity or overweight – this is a measurement that relates body weight to height, and having a higher BMI means carrying excess body weight
  • Must have a confirmed diagnosis of stress urinary incontinence – a condition where urine leaks during physical activities like coughing, sneezing, laughing, or exercising

Who Cannot Join the Study?

  • Have given birth within the last year before the screening visit
  • Have had urinary incontinence surgery or other types of surgical procedures in the past
  • Have recently received onabotulinumtoxin A (commonly known as Botox) injections into the bladder – this is a treatment that helps relax bladder muscles
  • Are currently taking any medications for urinary incontinence
  • Have gained or lost more than 11 pounds (approximately 5 kilograms) within the 90 days before the screening visit
  • Have type 1 diabetes, type 2 diabetes, or any other form of diabetes – conditions where the body cannot properly control blood sugar levels
  • Have experienced a heart condition within the 90 days before the screening visit
  • Have used any weight loss medications or alternative remedies for weight loss within the 180 days before the screening visit
  • Are currently pregnant or planning to become pregnant during the study
  • Are currently breastfeeding or planning to breastfeed during the study period

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Medical Concierge Centrum Medyczne Warsaw Poland

Verified Sites

Site Name City Country Status
Spitalul Clinic Judetean De Urgenta Ilfov Bucharest Romania
Gyncare MUDr. Michael Svec s.r.o. Plzen 2-Slovany Czechia
GYNORD plus s.r.o. Ostrava Czechia
Agyno s.r.o. Karlovy Vary Czechia
Gnosis Evomed S.R.L. Bucharest Romania

Other Sites

Site Name City Country Status
Spitalul Clinic Judetean De Urgenta Craiova Craiova Romania
Spitalul Clinic Prof.Dr.Theodor Burghele Bucharest Romania
Delta Health Care S.R.L. Bucharest Romania
Centrul Medical Unirea S.R.L. Brasov Romania
NEUMED gynekologicka ambulance s.r.o. Olomouc Czechia
Euromedis Sp. z o.o. Szczecin Poland
Spitalul Clinic Judetean De Urgenta Bihor Oradea Romania
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
In Vivo Sp. z o.o. Bydgoszcz Poland
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
Fundeni Clinical Institute Bucharest Romania
Ciybxdz Pluygmcu Sqlpuc Sibiu Romania
Slmzqarg Cjofax Dq Nmyswfwxre Dob Ccgfm Djqkpf Bucharest Romania
Gbhw szhtq s rkxt Prague Czechia
Mwhtfri Ckye Sarfsy Timisoara Romania
Ghiubltebz Rsfqbaav Sgz z odow Wroclaw Poland
G Cfvewqk Orcsztn sodfuc Olomouc Czechia
Khwxpuien sfosqz Nachod Czechia
Srzkxwbf Cigwmz Jdlwjqis Di Usufemp Bamnvx Brasov Romania
Prdqiehjerz Erhdirtclyqs Wroclaw Poland
Gleqciwmmld Skybgab sulnqb Brno-Stred Czechia
Atywmmy Sbo z oerq Poznan Poland
Pkppunx Mdchlhl Sblv Suceagu Romania
Utvzsjlw Bdjdtru &lvczcc Atwldl Benesov Czechia
Sepsyeva Dw Ulnpxwy At Mmdfdxzzlwxy Alqpknjnlxttek Sy Iylxgkejso Pnqxfmzbtcfozcst Gutovm Bucharest Romania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
01.10.2025
Poland Poland
Recruiting
01.10.2025
Romania Romania
Recruiting
01.10.2025

Trial locations

Orforglipron is an investigational medication being studied in this clinical trial. It is taken as a tablet by mouth once daily. Orforglipron belongs to a class of medications called GLP-1 receptor agonists, which work by mimicking the effects of a natural hormone in the body called glucagon-like peptide-1. This hormone helps regulate appetite and food intake, which can lead to weight loss. In this study, Orforglipron is being investigated to see if weight reduction may help improve symptoms of stress urinary incontinence in women who have obesity or are overweight. Unlike other GLP-1 medications that require injection, Orforglipron is a small-molecule drug that can be taken as a pill, making it more convenient for daily use.

Investigated diseases:

Stress Urinary Incontinence – This is a condition characterized by the involuntary leakage of urine during physical activities that increase pressure within the abdomen. Common triggers include coughing, sneezing, laughing, lifting heavy objects, or exercising. The condition occurs when the muscles and tissues that support the bladder and urethra become weakened or damaged. In women, this is often associated with pregnancy, childbirth, menopause, or aging. The weakening of the pelvic floor muscles reduces their ability to keep the urethra closed during moments of increased abdominal pressure. Excess body weight can worsen the condition by placing additional pressure on the bladder and surrounding structures.

Trial ID:
2025-522514-23-00
Protocol code:
J2A-MC-GZPS
Trial Phase:
Therapeutic confirmatory (Phase III)

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