Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT07202884

Conditions

Urinary Incontinence,Stress

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Orforglipron

Placebo

Study Details

Brief 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.

Conditions

Urinary Incontinence,Stress

Study ID

NCT07202884

Start date

Sep 30, 2025

Status verified date

Oct, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Orforglipron (GZS1)

Participants will receive orforglipron orally

placebo comparator: Placebo (GZS1)

Participants will receive placebo orally

experimental: Orforglipron (GZS2)

Participants will receive orforglipron orally

placebo comparator: Placebo (GZS2)

Participants will receive placebo orally

Interventions

Orforglipron

Administered orally

Placebo

Administered orally

Primary outcome measure

Change from Baseline in Incontinence Episode Frequency (IEF) [ Time Frame: Baseline, Week 52 ]

Central Contacts and Locations

Central contacts

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

Locations

University of Alabama -The Kirklin Clinic

Recruiting

Birmingham, Alabama, United States, 35233

Principal Investigator:

Gabriela Halder

AMR Clinical

Recruiting

Mobile, Alabama, United States, 36608

Principal Investigator:

Danilo Herrera

Matrix Clinical Research

Recruiting

Los Angeles, California, United States, 90057

Contacts

310-424-5922

Principal Investigator:

Peyman Banooni

Alarcon Urology Center

Recruiting

Montebello, California, United States, 90640

Principal Investigator:

Juan Alarcon

Colorado Clinical Research

Recruiting

Lakewood, Colorado, United States, 80228

Contacts

303-996-9649

Principal Investigator:

David Cahn

AMR Clinical

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

239-936-4421

Principal Investigator:

Kevin Fleishman

Altus Research

Recruiting

Lake Worth, Florida, United States, 33461

Contacts

561-641-0404

Principal Investigator:

Samuel Lederman

New Age Medical Research Corporation

Recruiting

Miami, Florida, United States, 33186

Contacts

305-596-9901

Principal Investigator:

Joanna Bedell

Emerald Coast OBGYN Clinical Research

Recruiting

Panama City, Florida, United States, 32405

Principal Investigator:

Samuel Wolf

Teak Research Consults

Recruiting

Lawrenceville, Georgia, United States, 30043

Principal Investigator:

Kamar Alabi

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Recruiting

Troy, Michigan, United States, 48098

Contacts

248-312-0025

Principal Investigator:

Neil Fraser

OB/GYN Associates of Erie

Recruiting

Erie, Pennsylvania, United States, 16507

Principal Investigator:

Michael Scutella

Next Level Urgent Care

Recruiting

Houston, Texas, United States, 77057

Contacts

832-460-3311

Principal Investigator:

Wilner Jeudy

Innovative Medical Research of Texas

Recruiting

Houston, Texas, United States, 77065

Principal Investigator:

Karyn Cumberbatch

Health Research of Hampton Roads, Inc.

Recruiting

Newport News, Virginia, United States, 23606

Contacts

757-591-8100

Principal Investigator:

George Freeman

Urology of Virginia

Recruiting

Virginia Beach, Virginia, United States, 23462

Principal Investigator:

Kurt McCammon

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Contacts

877-453-0404

Principal Investigator:

Ann Kolwitz

Seattle Clinical Research Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

206-522-3330

Principal Investigator:

Rebecca Dunsmoor-Su

OCT Research ULC

Recruiting

Kelowna, Canada, V1Y 1Z9

Contacts

250-862-8141

Principal Investigator:

Mallory Myers

Kelowna Health and Memory Centre

Recruiting

Kelowna, Canada, V1Y 5A8

Principal Investigator:

Colleen Maytham

Alpha Recherche Clinique - Lévis

Recruiting

Lévis, Canada, G6V 0C9

Contacts

418-380-1112

Principal Investigator:

Steeve Kwan Tat

The Fe/Male Health Centre

Recruiting

Oakville, Canada, L6H 3P1

Contacts

1 905 842 1393

Principal Investigator:

Richard Casey

Alpha Recherche Clinique

Recruiting

Québec, Canada, G2J 0C4

Principal Investigator:

Jonathan Cloutier

ALPHA Recherche Clinique

Recruiting

Québec, Canada, G3K 2P8

Contacts

418-847-1112

Principal Investigator:

Camille Walsh

CaRe Clinic

Recruiting

Red Deer, Canada, T4P 1K4

Contacts

1-587-797-4443

Principal Investigator:

Josias Badenhorst

Sunnybrook Research Institute

Recruiting

Toronto, Canada, M4N 3M5

Principal Investigator:

Sender Herschorn

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.