Under construction – not a live service
Sign in
Taking people in CanadaPhase 3

Tests orforglipron tablet in women with stress urinary incontinence and excess weight

Tests orforglipron tablets against placebo in adult women with leaking urine and overweight.

Key facts

Who runs it
Eli Lilly and Company
Where
Kelowna, Lévis, Oakville, Québec, Red Deer, and Toronto, CanadaSee the 7 sitesAlso in 8 other countries, 112 sites
Registry title
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Status
Recruiting
Phase
Phase 3
People taking part
1,000 people, planned
Started
30 Sept 2025
Expected to end
Mar 2028
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Orforglipron
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult women who leak urine during activity such as coughing or exercise (stress urinary incontinence) and who have obesity or overweight.

Age
18 years or older
Sex
Women only
Disease stage
Diagnosis of stress urinary incontinence
Earlier treatment
Cannot join if they had urinary incontinence surgery, recent Botox bladder injections, or any anti-obesity medication or alternative weight loss remedies within 180 days before screening. Cannot join if they currently take medicines for urinary incontinence.
Biomarker or test result
Body mass index (BMI) of 27 kg/m2 or higher at screening

Main reasons for not taking part

  • Type 1 diabetes, type 2 diabetes, or any other type of diabetes
  • Gave birth within one year of screening
  • Body weight change of more than 11 pounds (5 kg) within 90 days before screening
  • A cardiovascular health condition within 90 days before screening
  • Pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed during the study

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

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

Who cannot take part

  • Have had urinary incontinence surgery
  • Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence
  • Have had a change in body weight of more than 11 pounds within 90 days prior to screening
  • Have used any anti-obesity medication or alternative weight loss remedies within 180 days prior to screening
  • Have had a cardiovascular health condition within 90 days prior to screening
  • Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
  • Have given birth within one year of screening
  • Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study

Where in Canada

Also in 8 other countries, 112 sites

  • Kelowna Health and Memory CentreKelowna, CanadaContact: Colleen Maytham (principal investigator)Taking people
  • OCT Research ULCKelowna, CanadaContact: Mallory Myers (principal investigator)Taking people
  • Alpha Recherche Clinique - LévisLévis, CanadaContact: Steeve Kwan Tat (principal investigator)Taking people
  • The Fe/Male Health CentreOakville, CanadaContact: Richard Casey (principal investigator)Taking people
  • Alpha Recherche CliniqueQuébec, CanadaContact: Jonathan Cloutier (principal investigator)Taking people
  • CaRe ClinicRed Deer, CanadaContact: Josias Badenhorst (principal investigator)Taking people
  • Sunnybrook Research InstituteToronto, CanadaContact: Sender Herschorn (principal investigator)Taking people

About the trial

What the trial wants to find out

The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2. Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity or overweight. SUI is leaking urine during movement or activity such as coughing or exercising. Participation in the study will last about 58 weeks from screening to safety follow-up.

The 4 groups in the trial

  • Orforglipron (GZS1)Treatment being tested

    Participants will receive orforglipron orally

    Treatment: Orforglipron

  • Placebo (GZS1)Placebo, for comparison

    Participants will receive placebo orally

    Treatment: Placebo

  • Orforglipron (GZS2)Treatment being tested

    Participants will receive orforglipron orally

    Treatment: Orforglipron

  • Placebo (GZS2)Placebo, for comparison

    Participants will receive placebo orally

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Plain-language title
Tests orforglipron tablet in women with stress urinary incontinence and excess weightGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 November 2026