NCT07202884 · Eli Lilly and Company
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
(RESTRAIN-SUI)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Mobile, Alabama
- Mesa, Arizona
- Los Angeles, California
- Montebello, California
- Tustin, California
- Lakewood, Colorado
- Fort Myers, Florida
- Lake Worth, Florida
- Miami, Florida
- Panama City, Florida
- Lawrenceville, Georgia
And 8 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations