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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama -The Kirklin Clinic
  Birmingham, Alabama, United States Recruiting
• AMR Clinical
  Mobile, Alabama, United States Recruiting
• Matrix Clinical Research
  Los Angeles, California, United States Recruiting
• Alarcon Urology Center
  Montebello, California, United States Recruiting
• Colorado Clinical Research
  Lakewood, Colorado, United States Recruiting
• AMR Clinical
  Fort Myers, Florida, United States Recruiting

+70 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Prophylactic antibiotics to reduce post-procedure UTIs after urethral bulking

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• Evaluating the impact of different mesh widths in surgery for urinary incontinence

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.