Recruiting PHASE3 Urinary Incontinence,Stress

New treatment option for Urinary Incontinence,Stress

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

ClinicalTrials.gov ID: NCT07202884

What this study is testing

What is Orforglipron?

Orforglipron is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for urinary incontinence,stress.

Also referred to as LY3502970.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, women only

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Birmingham, Alabama, United States
  • Mobile, Alabama, United States
  • Mesa, Arizona, United States
  • Los Angeles, California, United States
  • Montebello, California, United States
  • Tustin, California, United States
  • Lakewood, Colorado, United States
  • Fort Myers, Florida, United States
  • Lake Worth, Florida, United States
  • Miami, Florida, United States
  • Panama City, Florida, United States
  • Lawrenceville, Georgia, United States
  • Troy, Michigan, United States
  • Erie, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Newport News, Virginia, United States
  • Virginia Beach, Virginia, United States
  • Bellevue, Washington, United States
  • Seattle, Washington, United States

+ 91 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Mesa, Arizona, United States; Los Angeles, California, United States; Montebello, California, United States; Tustin, California, United States and 105 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.