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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well and safely orforglipron works in adult women with obesity or overweight who have stress urinary incontinence. This means leaking urine during activities like coughing or exercising. Taking part lasts about 58 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI) of 27 or higher at screening. BMI is a measure based on height and weight.
  • Have been diagnosed with stress urinary incontinence, or urine leaks during movement or activity.

Who can't join

  • Have had surgery to treat urine leaks.
  • Have recently had Botox injections in the bladder or are taking medicine for urine leaks.
  • Have given birth within 1 year before screening.
  • Have gained or lost more than 11 pounds within 90 days before screening.
  • Have used weight-loss medicine or alternative weight-loss remedies within 180 days before screening.
  • Have any type of diabetes.
  • Have had a heart or blood vessel health condition within 90 days before screening.
  • Are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (21)

AL

AZ

  • Urologic Surgeons of Arizona · Mesa, AZ 85206Kashif Alvi · Principal investigatorMore trials in Mesa

CA

CO

FL

GA

MI

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division · Troy, MI 48098 · Study contact · 248-312-0025Neil Fraser · Principal investigatorMore trials in Troy

PA

TX

VA

WA