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

Last updated: March 19, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

Orforglipron

Clinical Study ID

NCT07202884
27672
2025-522514-23-00
J2A-MC-GZS1
J2A-MC-GZS2
J2A-MC-GZPS
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher atscreening

  • Have a diagnosis of stress urinary incontinence

Exclusion

Exclusion Criteria:

  • Have had urinary incontinence surgery

  • Have recently received onabotulinumtoxin A (Botox) bladder injections or currentlytaking 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 toscreening

  • Have used any anti-obesity medication or alternative weight loss remedies within 180days 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 breastfeedfor the duration of the study

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 30, 2025
Estimated Completion Date:
March 31, 2028

Connect with a study center

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    Canada

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  • The Fe/Male Health Centre

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    Québec, G2J 0C4
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    Québec 6325494, G3K 2P8
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    Romania

    Site Not Available

  • Spitalul Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara

    Timișoara 665087, 300723
    Romania

    Site Not Available

  • Hallym University Sacred Heart Hospital

    Anyang-si, 14068
    South Korea

    Active - Recruiting

  • Hallym University Sacred Heart Hospital

    Anyang-si 1846898, 14068
    South Korea

    Site Not Available

  • The Catholic University of Korea, Bucheon St. Mary's Hospital

    Bucheon-si, 14647
    South Korea

    Active - Recruiting

  • The Catholic University of Korea, Bucheon St. Mary's Hospital

    Bucheon-si 1838716, 14647
    South Korea

    Site Not Available

  • Pusan National University Hospital

    Busan, 49241
    South Korea

    Active - Recruiting

  • Pusan National University Hospital

    Busan 1838524, 49241
    South Korea

    Site Not Available

  • Chonnam National University Hospital

    Gwangju, 61469
    South Korea

    Active - Recruiting

  • Chonnam National University Hospital

    Gwangju 1841811, 61469
    South Korea

    Site Not Available

  • Kyungpook National University Hospital

    Junggu, 41944
    South Korea

    Active - Recruiting

  • Kyungpook National University Hospital

    Junggu 8606540, 41944
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

  • University of Alabama -The Kirklin Clinic

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • AMR Clinical

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • University of Alabama -The Kirklin Clinic

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • AMR Clinical

    Mobile 4076598, Alabama 4829764 36608
    United States

    Site Not Available

  • Urologic Surgeons of Arizona

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Urologic Surgeons of Arizona

    Mesa 5304391, Arizona 5551752 85206
    United States

    Site Not Available

  • Matrix Clinical Research

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Alarcon Urology Center

    Montebello, California 90640
    United States

    Active - Recruiting

  • Prestige Medical Group

    Tustin, California 92780
    United States

    Active - Recruiting

  • Matrix Clinical Research

    Los Angeles 5368361, California 5332921 90057
    United States

    Site Not Available

  • Alarcon Urology Center

    Montebello 5374322, California 5332921 90640
    United States

    Site Not Available

  • Prestige Medical Group

    Tustin 5404119, California 5332921 92780
    United States

    Site Not Available

  • Colorado Clinical Research

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Colorado Clinical Research

    Lakewood 5427946, Colorado 5417618 80228
    United States

    Site Not Available

  • AMR Clinical

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Altus Research

    Lake Worth, Florida 33461
    United States

    Active - Recruiting

  • New Age Medical Research Corporation

    Miami, Florida 33186
    United States

    Active - Recruiting

  • Emerald Coast OBGYN Clinical Research

    Panama City, Florida 32405
    United States

    Active - Recruiting

  • AMR Clinical

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • Altus Research

    Lake Worth 4161422, Florida 4155751 33461
    United States

    Site Not Available

  • New Age Medical Research Corporation

    Miami 4164138, Florida 4155751 33186
    United States

    Site Not Available

  • Emerald Coast OBGYN Clinical Research

    Panama City 4167694, Florida 4155751 32405
    United States

    Site Not Available

  • Teak Research Consults

    Lawrenceville, Georgia 30043
    United States

    Active - Recruiting

  • Teak Research Consults

    Lawrenceville 4205196, Georgia 4197000 30043
    United States

    Site Not Available

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan 48098
    United States

    Active - Recruiting

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy 5012639, Michigan 5001836 48098
    United States

    Site Not Available

  • OB/GYN Associates of Erie

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • OB/GYN Associates of Erie

    Erie 5188843, Pennsylvania 6254927 16507
    United States

    Site Not Available

  • Clinical Research of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19114
    United States

    Site Not Available

  • Innovative Medical Research of Texas

    Houston, Texas 77065
    United States

    Active - Recruiting

  • Next Level Urgent Care

    Houston, Texas 77057
    United States

    Active - Recruiting

  • Innovative Medical Research of Texas

    Houston 4699066, Texas 4736286 77065
    United States

    Site Not Available

  • Next Level Urgent Care

    Houston 4699066, Texas 4736286 77057
    United States

    Active - Recruiting

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • Urology of Virginia

    Virginia Beach, Virginia 23462
    United States

    Active - Recruiting

  • Health Research of Hampton Roads, Inc.

    Newport News 4776024, Virginia 6254928 23606
    United States

    Site Not Available

  • Urology of Virginia

    Virginia Beach 4791259, Virginia 6254928 23462
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Seattle Clinical Research Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Northwest Clinical Research Center

    Bellevue 5786882, Washington 5815135 98007
    United States

    Site Not Available

  • Seattle Clinical Research Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

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