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NCT07202884PHASE3Recruiting

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

Eli Lilly and Company

Start Date

9/30/2025

Completion Date

3/1/2028

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

Orforglipron

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Urinary Incontinence,Stress

Locations

University of Alabama -The Kirklin Clinic

Birmingham, Alabama 35233

United States

AMR Clinical

Mobile, Alabama 36608

United States

Urologic Surgeons of Arizona

Mesa, Arizona 85206

United States

Matrix Clinical Research

Los Angeles, California 90057

United States

Alarcon Urology Center

Montebello, California 90640

United States

Prestige Medical Group

Tustin, California 92780

United States

Colorado Clinical Research

Lakewood, Colorado 80228

United States

AMR Clinical

Fort Myers, Florida 33912

United States

Altus Research

Lake Worth, Florida 33461

United States

New Age Medical Research Corporation

Miami, Florida 33186

United States

Emerald Coast OBGYN Clinical Research

Panama City, Florida 32405

United States

Teak Research Consults

Lawrenceville, Georgia 30043

United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan 48098

United States

OB/GYN Associates of Erie

Erie, Pennsylvania 16507

United States

Clinical Research of Philadelphia

Philadelphia, Pennsylvania 19114

United States

Next Level Urgent Care

Houston, Texas 77057

United States

Innovative Medical Research of Texas

Houston, Texas 77065

United States

Health Research of Hampton Roads, Inc.

Newport News, Virginia 23606

United States

Urology of Virginia

Virginia Beach, Virginia 23462

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Seattle Clinical Research Center

Seattle, Washington 98104

United States

OCT Research ULC

Kelowna, V1Y 1Z9

Canada

Kelowna Health and Memory Centre

Kelowna, V1Y 5A8

Canada

Alpha Recherche Clinique - Lévis

Lévis, G6V 0C9

Canada

The Fe/Male Health Centre

Oakville, L6H 3P1

Canada

Alpha Recherche Clinique

Québec, G2J 0C4

Canada

ALPHA Recherche Clinique

Québec, G3K 2P8

Canada

CaRe Clinic

Red Deer, T4P 1K4

Canada

Sunnybrook Research Institute

Toronto, M4N 3M5

Canada

Peking University People's Hospital

Beijing, 100034

China

Xuanwu Hospital Capital Medical University

Beijing, 100053

China

Peking University Third Hospital

Beijing, 100091

China

Peking University First Hospital

Beijing, 102600

China

Sichuan Provincial People's Hospital

Chengdu, 610072

China

Chengdu Women and Children Center Hospital

Chengdu, 610091

China

2nd Affiliated Hospital Chongqing Medical University

Chongqing, 400010

China

Zhujiang Hospital

Guangzhou, 510280

China

The First Affiliated Hospital of Jinan University

Guangzhou, 510630

China

Zhejiang Provincial People's Hospital

Hangzhou, 310014

China

Second Affiliated hospital of Anhui Medical University

Hefei, 230000

China

Gansu Provincial Hospital

Lanzhou, 730000

China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, 210000

China

Ningbo First Hospital

Ningbo, 315010

China

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, 200011; 200090

China

Peking University Shenzhen Hospital

Shenzhen, 518036

China

The Second Affiliated Hospital of Soochow University

Suzhou, 215004

China

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430030

China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061

China

The First Affiliated hospital of Xiamen University

Xiamen, 361003

China

General Hospital of Ningxia Medical University

Yinchuan, 750004

China

Afimed - Urologicka ambulance

Benešov, 256 01

Czechia

Gynekologie Šottner

Brno, 603 00

Czechia

Centrum Panevniho Dna

Karlovy Vary, 360 17

Czechia

Kestr-gyn

Náchod, 547 01

Czechia

G-CENTRUM Olomouc

Olomouc, 772 00

Czechia

NEUMED gynekologická ambulance

Olomouc, 779 00

Czechia

GYNORD plus

Ostrava, 709 00

Czechia

Gyncare

Pilsen, 301 00

Czechia

Nestátní zdravotnické zařízení GONA

Prague, 110 00

Czechia

Devasya Superspeciality Kidney & Multispeciality Hospitals

Ahmedabad, 380013

India

Apollo Hospitals Ahmedabad

Ahmedabad, 382428

India

KLES Dr. Prabhakar Kore Hospital & M.R.C

Belagavi, 590010

India

Belagavi Institute of Medical Sciences - Belagavi

Belgavi, 590019

India

All India Institute of Medical Sciences

Bhubaneswar, 751019

India

Postgraduate Institute of Medical Education & Research

Chandigarh, 160012

India

Apollo Hospitals - Chennai

Chennai, 600006

India

Malla Reddy Narayana Multispeciality Hospital

Hyderabad, 500055

India

Ketki Nursing Home & Urology Hospital

Nagpur, 440012

India

Sir Ganga Ram Hospital

New Delhi, 110060

India

Lifepoint Multispeciality Hospital

Pune, 411057

India

All India Institute of Medical Sciences

Raipur, 492099

India

All India Institute of Medical Sciences - Rishikesh

Rishikesh, 249203

India

Surat Institute of Digestive Sciences Hospitals

Surat, 395002

India

Banaras Hindu University

Varanasi, 221005

India

Hasegawa Hospital - Arakawa

Arakawa City, 116-0014

Japan

Takasu Nephrology and Urology Clinic

Chiba, 261-0004

Japan

Yotsuya Medical Cube

Chiyoda City, 102-0084

Japan

St. Luke's International Hospital

Chūōku, 104-8560

Japan

Mito Medical Center

Higashiibaraki, 311-3117

Japan

Nihon University Itabashi Hospital

Itabashiku, 173-8610

Japan

Kokura Memorial Hospital

Kitakyushu, 802-8555

Japan

Touyu Clinic

Matsudo, 270-0034

Japan

Tokyo Saiseikai Central Hospital

Minatoku, 108-0073

Japan

Koujunkai Daido Clinic

Nagoya, 457-8511

Japan

Women's Clinic LUNA NEXT STAGE

Naka-ku, Yokohama-Shi, 231-0861

Japan

Chiba Saiseikai Narashino hospital

Narashino, 275-8580

Japan

Nakazawa Nephrology and Urology Clinic

Nonoichi, 921-8824

Japan

Miyabi Urogyne Clinic

Okayama, 700-0822

Japan

Nakatsu Hospital

Osaka, 530-0012

Japan

Yukigaya Urology Clinic

Ōta-ku, 145-0065

Japan

Kashiwazaki Obstetrics and Gynecology Clinic

Saitama-shi, 330-0855

Japan

Izumi Chuo Hospital

Sendai, 981-3121

Japan

Toride Urology Clinic

Toride, 302-0021

Japan

Tsukuba Urocare Clinic

Tsukuba, 305-0821

Japan

Medical Center Metas

Chihuahua City, 31110

Mexico

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207

Mexico

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.

Ciudad Madero, 89440

Mexico

Health Pharma Querétaro

Juriquilla, 76230

Mexico

RM Pharma Specialists - Unidad Especializada en Datos

Mexico City, 03100

Mexico

Centro de Oncología de Precisión - Mexico City

Mexico City, 03330

Mexico

Quemex Medical and Research

Mexico City, 14308

Mexico

Medical Care and Research SA de CV

Mérida, 97070

Mexico

Clinstile, S.A. de C.V.

México, 06700

Mexico

Jose Gerardo Garza Leal

Monterrey, 64060

Mexico

Centro de investigación y control metabólico

Monterrey, 66465

Mexico

Centro de Investigacion Clinica Chapultepec

Morelia, 58260

Mexico

Medimanage Research

Tlalpan, 14050

Mexico

IN VIVO

Bydgoszcz, 85-048

Poland

AIDPORT Sp. z o.o.

Skórzewo, 60-185

Poland

Centrum Medyczne Euromedis

Szczecin, 70-111

Poland

Medical Concierge Centrum Medyczne

Warsaw, 02-798

Poland

Centrum Medyczne Ginemedica

Wroclaw, 50-414

Poland

EMC Instytut Medyczny SA

Wroclaw, 54-239

Poland

Centrul Medical Unirea

Brasov, 500091

Romania

Spitalul Clinic Judetean de Urgenta (Brasov)

Brasov, 500152

Romania

Spitalul Clinic de Nefrologie Doctor Carol Davila

Bucharest, 010731

Romania

Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila

Bucharest, 010825

Romania

Delta Health Care

Bucharest, 014142

Romania

Spitalul Clinic Colentina

Bucharest, 020125

Romania

Spitalul de Urgenta al Ministerului Administratiei si Internelor "Prof. Dr. Dimitrie Gerota"

Bucharest, 021373

Romania

Spitalul Clinic Județean de Urgență Ilfov

Bucharest, 022105

Romania

Fundeni Clinical Institute

Bucharest, 022328

Romania

Gnosis Evomed S.R.L.

Bucharest, 030913

Romania

Spitalul Clinic Profesor Doctor Theodor Burghele

Bucharest, 050659

Romania

Spitalul Clinic Județean de Urgență

Craiova, 200642

Romania

Spitalul Clinic Judetean De Urgenta Bihor

Oradea, 410169

Romania

Clinica Polisano

Sibiu, 550253

Romania

Polaris Medical SA

Suceagu, 407062

Romania

S.C. Materna Care S.R.L.

Timișoara, 300645

Romania

Spitalul Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara

Timișoara, 300723

Romania

Hallym University Sacred Heart Hospital

Anyang-si, 14068

South Korea

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

Bucheon-si, 14647

South Korea

Pusan National University Hospital

Busan, 49241

South Korea

Chonnam National University Hospital

Gwangju, 61469

South Korea

Kyungpook National University Hospital

Junggu, 41944

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea