Testing Orforglipron against a placebo for stress urinary incontinence
Official title: A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
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
- Phase 3
- 4 groups
- Sites in Kelowna, Lévis and 4 more cities
- Recruiting
Interventions
- Medication
Orforglipron
Administered orally
- Medication
Placebo
Administered orally
Canadian Sites (8)
8 of 8 recruiting
- Recruiting
OCT Research ULC
Kelowna
- Recruiting
Kelowna Health and Memory Centre
Kelowna
- Recruiting
Alpha Recherche Clinique - Lévis
Lévis
- Recruiting
The Fe/Male Health Centre
Oakville
- Recruiting
Alpha Recherche Clinique
Québec
- Recruiting
ALPHA Recherche Clinique
Québec
- Recruiting
CaRe Clinic
Red Deer
- Recruiting
Sunnybrook Research Institute
Toronto
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +Have a diagnosis of stress urinary incontinence
Exclusion
- −Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence
- −Have given birth within one year of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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 type 1 diabetes, type 2 diabetes, or any other type of diabetes
- −Have had a cardiovascular health condition within 90 days prior to screening
- −Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study
- −Have had urinary incontinence surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Groups A and C receive Orforglipron.
Registry label: A: Orforglipron (GZS1) · C: Orforglipron (GZS2)
Groups B and D, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receive Placebo.
Registry label: B: Placebo (GZS1) · D: Placebo (GZS2)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,000 people.
The study is currently expected to finish around March 2028.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 52.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change from BaselineBaselineYour starting measurements, taken before treatment begins.Read more → in Incontinence Episode Frequency (IEF) — measured over Baseline, Week 52.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07202884 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About OrforglipronDrug
Administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 52.
The study as a whole is currently expected to finish around 2028-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 9 locations, including: Kelowna, Canada; Lévis, Canada; Oakville, Canada; Québec, Canada; Red Deer, Canada; Toronto, Canada, and 3 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Seattle Clinical Research Center
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.