RecruitingPhase 3NCT07202884

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

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight

Sponsor

Eli Lilly and Company

Enrollment

1,000 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

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 Criteria8

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

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Interventions

DRUGOrforglipron

Administered orally

DRUGPlacebo

Administered orally

Locations(136)

University of Alabama -The Kirklin Clinic

Birmingham, Alabama, United States

AMR Clinical

Mobile, Alabama, United States

Urologic Surgeons of Arizona

Mesa, Arizona, United States

Matrix Clinical Research

Los Angeles, California, United States

Alarcon Urology Center

Montebello, California, United States

Prestige Medical Group

Tustin, California, United States

Colorado Clinical Research

Lakewood, Colorado, United States

AMR Clinical

Fort Myers, Florida, United States

Altus Research

Lake Worth, Florida, United States

New Age Medical Research Corporation

Miami, Florida, United States

Emerald Coast OBGYN Clinical Research

Panama City, Florida, United States

Teak Research Consults

Lawrenceville, Georgia, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

OB/GYN Associates of Erie

Erie, Pennsylvania, United States

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, United States

Next Level Urgent Care

Houston, Texas, United States

Innovative Medical Research of Texas

Houston, Texas, United States

Health Research of Hampton Roads, Inc.

Newport News, Virginia, United States

Urology of Virginia

Virginia Beach, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Seattle Clinical Research Center

Seattle, Washington, United States

OCT Research ULC

Kelowna, Canada

Kelowna Health and Memory Centre

Kelowna, Canada

Alpha Recherche Clinique - Lévis

Lévis, Canada

The Fe/Male Health Centre

Oakville, Canada

Alpha Recherche Clinique

Québec, Canada

ALPHA Recherche Clinique

Québec, Canada

CaRe Clinic

Red Deer, Canada

Sunnybrook Research Institute

Toronto, Canada

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Xuanwu Hospital Capital Medical University

Beijing, China

Peking University Third Hospital

Beijing, China

Chengdu Women and Children Center Hospital

Chengdu, China

2nd Affiliated Hospital Chongqing Medical University

Chongqing, China

Zhujiang Hospital

Guangzhou, China

The First Affiliated Hospital of Jinan University

Guangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Second Affiliated hospital of Anhui Medical University

Hefei, China

Gansu Provincial Hospital

Lanzhou, China

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

Nanjing, China

Ningbo First Hospital

Ningbo, China

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

Peking University Shenzhen Hospital

Shenzhen, China

The Second Affiliated Hospital of Soochow University

Suzhou, China

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

Wuhan, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The First Affiliated hospital of Xiamen University

Xiamen, China

General Hospital of Ningxia Medical University

Yinchuan, China

Afimed - Urologicka ambulance

Benešov, Czechia

Gynekologie Šottner

Brno, Czechia

Centrum Panevniho Dna

Karlovy Vary, Czechia

Kestr-gyn

Náchod, Czechia

G-CENTRUM Olomouc

Olomouc, Czechia

NEUMED gynekologická ambulance

Olomouc, Czechia

GYNORD plus

Ostrava, Czechia

Gyncare

Pilsen, Czechia

Nestátní zdravotnické zařízení GONA

Prague, Czechia

Devasya Superspeciality Kidney & Multispeciality Hospitals

Ahmedabad, India

Apollo Hospitals Ahmedabad

Ahmedabad, India

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

Belagavi, India

Belagavi Institute of Medical Sciences - Belagavi

Belgavi, India

All India Institute of Medical Sciences

Bhubaneswar, India

Postgraduate Institute of Medical Education & Research

Chandigarh, India

Apollo Hospitals - Chennai

Chennai, India

Malla Reddy Narayana Multispeciality Hospital

Hyderabad, India

Ketki Nursing Home & Urology Hospital

Nagpur, India

Sir Ganga Ram Hospital

New Delhi, India

Lifepoint Multispeciality Hospital

Pune, India

All India Institute of Medical Sciences

Raipur, India

All India Institute of Medical Sciences - Rishikesh

Rishikesh, India

Surat Institute of Digestive Sciences Hospitals

Surat, India

Banaras Hindu University

Varanasi, India

Hasegawa Hospital - Arakawa

Arakawa City, Japan

Takasu Nephrology and Urology Clinic

Chiba, Japan

Yotsuya Medical Cube

Chiyoda City, Japan

St. Luke's International Hospital

Chūōku, Japan

Mito Medical Center

Higashiibaraki, Japan

Nihon University Itabashi Hospital

Itabashiku, Japan

Kokura Memorial Hospital

Kitakyushu, Japan

Touyu Clinic

Matsudo, Japan

Tokyo Saiseikai Central Hospital

Minatoku, Japan

Koujunkai Daido Clinic

Nagoya, Japan

Women's Clinic LUNA NEXT STAGE

Naka-ku, Yokohama-Shi, Japan

Chiba Saiseikai Narashino hospital

Narashino, Japan

Nakazawa Nephrology and Urology Clinic

Nonoichi, Japan

Miyabi Urogyne Clinic

Okayama, Japan

Nakatsu Hospital

Osaka, Japan

Yukigaya Urology Clinic

Ōta-ku, Japan

Kashiwazaki Obstetrics and Gynecology Clinic

Saitama-shi, Japan

Izumi Chuo Hospital

Sendai, Japan

Toride Urology Clinic

Toride, Japan

Tsukuba Urocare Clinic

Tsukuba, Japan

Medical Center Metas

Chihuahua City, Mexico

Scientia Investigacion Clinica S.C.

Chihuahua City, Mexico

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

Ciudad Madero, Mexico

Health Pharma Querétaro

Juriquilla, Mexico

RM Pharma Specialists - Unidad Especializada en Datos

Mexico City, Mexico

Centro de Oncología de Precisión - Mexico City

Mexico City, Mexico

Quemex Medical and Research

Mexico City, Mexico

Medical Care and Research SA de CV

Mérida, Mexico

Clinstile, S.A. de C.V.

México, Mexico

Jose Gerardo Garza Leal

Monterrey, Mexico

Centro de investigación y control metabólico

Monterrey, Mexico

Centro de Investigacion Clinica Chapultepec

Morelia, Mexico

Medimanage Research

Tlalpan, Mexico

IN VIVO

Bydgoszcz, Poland

AIDPORT Sp. z o.o.

Skórzewo, Poland

Centrum Medyczne Euromedis

Szczecin, Poland

Medical Concierge Centrum Medyczne

Warsaw, Poland

Centrum Medyczne Ginemedica

Wroclaw, Poland

EMC Instytut Medyczny SA

Wroclaw, Poland

Centrul Medical Unirea

Brasov, Romania

Spitalul Clinic Judetean de Urgenta (Brasov)

Brasov, Romania

Spitalul Clinic de Nefrologie Doctor Carol Davila

Bucharest, Romania

Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila

Bucharest, Romania

Delta Health Care

Bucharest, Romania

Spitalul Clinic Colentina

Bucharest, Romania

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

Bucharest, Romania

Spitalul Clinic Județean de Urgență Ilfov

Bucharest, Romania

Fundeni Clinical Institute

Bucharest, Romania

Gnosis Evomed S.R.L.

Bucharest, Romania

Spitalul Clinic Profesor Doctor Theodor Burghele

Bucharest, Romania

Spitalul Clinic Județean de Urgență

Craiova, Romania

Spitalul Clinic Judetean De Urgenta Bihor

Oradea, Romania

Clinica Polisano

Sibiu, Romania

Polaris Medical SA

Suceagu, Romania

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

Timișoara, Romania

Spitalul Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara

Timișoara, Romania

Hallym University Sacred Heart Hospital

Anyang-si, South Korea

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

Bucheon-si, South Korea

Pusan National University Hospital

Busan, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Kyungpook National University Hospital

Junggu, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07202884