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RecruitingPhase 3

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

Eli Lilly and Company · NCT07202884

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1000
US sites recruiting
18
Study start
September 30, 2025
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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. Participation in the study will last about 58 weeks from screening to safety follow-up.

Being studied: Orforglipron; Placebo

Conditions: Urinary Incontinence,Stress

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Alabama -The Kirklin Clinic

    Birmingham, AL 35233

    Site contact: Gabriela Halder

  • AMR Clinical

    Mobile, AL 36608

    Site contact: Danilo Herrera

  • Matrix Clinical Research

    Los Angeles, CA 90057

    Site contact: 310-424-5922

  • Alarcon Urology Center

    Montebello, CA 90640

    Site contact: Juan Alarcon

  • Colorado Clinical Research

    Lakewood, CO 80228

    Site contact: 303-996-9649

  • AMR Clinical

    Fort Myers, FL 33912

    Site contact: 239-936-4421

  • Altus Research

    Lake Worth, FL 33461

    Site contact: 561-641-0404

  • New Age Medical Research Corporation

    Miami, FL 33186

    Site contact: 305-596-9901

  • Emerald Coast OBGYN Clinical Research

    Panama City, FL 32405

    Site contact: Samuel Wolf

  • Teak Research Consults

    Lawrenceville, GA 30043

    Site contact: Kamar Alabi

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, MI 48098

    Site contact: 248-312-0025

  • OB/GYN Associates of Erie

    Erie, PA 16507

    Site contact: Michael Scutella

  • Next Level Urgent Care

    Houston, TX 77057

    Site contact: 832-460-3311

  • Innovative Medical Research of Texas

    Houston, TX 77065

    Site contact: Karyn Cumberbatch

  • Health Research of Hampton Roads, Inc.

    Newport News, VA 23606

    Site contact: 757-591-8100

  • Urology of Virginia

    Virginia Beach, VA 23462

    Site contact: Kurt McCammon

  • Northwest Clinical Research Center

    Bellevue, WA 98007

    Site contact: 877-453-0404

  • Seattle Clinical Research Center

    Seattle, WA 98104

    Site contact: 206-522-3330

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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A Study of Orforglipron in Female Participants With Stress Urinary… (NCT07202884) | Bored Studies