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Orforglipron for women with stress urinary incontinence who are overweight or have obesity

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 Interventional Eli Lilly and Company · NCT07202884

This trial will test whether orforglipron reduces urine leakage in adult women with stress urinary incontinence who are overweight or have obesity.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexFemale
SponsorEli Lilly and Company Industry-sponsored
Locations136 sites (Birmingham, Alabama and 135 other locations)
Trial IDNCT07202884 on ClinicalTrials.gov

What this trial studies

The GZPS master protocol runs two parallel Phase 3 studies (J2A-MC-GZS1 and J2A-MC-GZS2) that randomize adult female participants with stress urinary incontinence and a BMI ≥27 to receive orforglipron or placebo. Participants will take the study medication or placebo and attend visits over about 58 weeks from screening through safety follow-up. Key exclusions include diabetes, recent urinary incontinence surgery, recent Botox or other incontinence treatments, recent large weight changes, recent anti-obesity medication use, and pregnancy or breastfeeding. The trials compare leakage outcomes and safety between orforglipron and placebo to see if the drug reduces stress-related urine loss.

Who should consider this trial

Good fit: Adult women with stress urinary incontinence and a BMI of 27 kg/m2 or higher who are not pregnant, do not have diabetes, have not had recent incontinence surgery or Botox injections, and are willing to attend in-person visits at a study site are ideal candidates.

Not a fit: Women with type 1 or type 2 diabetes, recent urinary incontinence surgery, recent Botox injections, current medications for urinary incontinence, recent significant weight change, recent anti-obesity drug use, or who are pregnant or breastfeeding are unlikely to be eligible and may not benefit.

Why it matters

Potential benefit: If successful, it could reduce stress-related urine leakage and improve daily comfort and quality of life for overweight women with SUI.

How similar studies have performed: Previous weight-loss interventions, including some GLP-1–based approaches, have reduced urinary incontinence in other trials, but using orforglipron specifically for SUI is a novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Where this trial is running

Birmingham, Alabama and 135 other locations

+86 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urinary Incontinence,Stress
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.