A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight

What Was Tested

The trial (phase 3) is built around Orforglipron (Foundayo, non-peptide).

The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2.

SUI is leaking urine during movement or activity such as coughing or exercising.

It had four arms (groups): Orforglipron (GZS1) (experimental), Placebo (GZS1) (placebo comparator), Orforglipron (GZS2) (experimental) and Placebo (GZS2) (placebo comparator).

Participants will receive orforglipron orally.

Participants will receive placebo orally.

Participants will receive orforglipron orally.

The registry classes the interventions as drug.

Who Took Part

The registry lists 1000 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: have had urinary incontinence surgery; have recently received onabotulinumtoxin a (botox) bladder injections or currently taking medications for urinary incontinence; have given birth within one year of screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Orforglipron (Foundayo, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Orforglipron (Foundayo, non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Orforglipron (Foundayo, non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2025-09-30 with completion listed for 2028-03.

It ran at 136 sites in United States (21), China (21), Japan (20), Romania (16), India (15) and Mexico (13).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from Baseline in Incontinence Episode Frequency (IEF) (time frame: Baseline, Week 52).

It also tracked 6 secondary outcomes, for example Percent Change from Baseline in Body Weight, Change from Baseline in Urinary Incontinence-Specific Quality of Life, Change from Baseline in Number of Continence Pad (CAPD) Used Per Week, Change from Baseline in Patient Global Impression of Condition, Percent Change from Baseline in Total Cholesterol and Change from Baseline in Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 1000 people.

With 1000 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Orforglipron (Foundayo, non-peptide) compound page, all human trials.