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Orforglipron for stress urinary incontinence in women with obesity or overweight

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

10 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Orforglipron – This is an oral medication taken as a tablet once daily by mouth. It is currently an investigational drug being developed by Eli Lilly and is not yet approved for medical use. Orforglipron is a GLP-1 receptor agonist, which means it works by activating receptors in the body that respond to a natural hormone called glucagon-like peptide-1 (GLP-1). When these receptors are activated, they help reduce appetite and food intake, which can lead to weight loss. Unlike traditional GLP-1 medications that must be given by injection, Orforglipron is a small-molecule compound that can be absorbed through the digestive system when taken as a pill. This medication is being studied for various conditions where weight loss may provide therapeutic benefits, including stress urinary incontinence in women with excess body weight.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522514-23-00Protocol codeJ2A-MC-GZPSEstimated enrolment1 000 patientsSponsorEli Lilly & Co.

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