A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight (RESTRAIN-SUI)

June 3, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • Canada
      • Kelowna, Canada, V1Y 1Z9
        • Recruiting
        • OCT Research ULC
        • Contact:
          • Phone Number: 250-862-8141
        • Principal Investigator:
          • Mallory Myers
      • Kelowna, Canada, V1Y 5A8
        • Recruiting
        • Kelowna Health and Memory Centre
        • Principal Investigator:
          • Colleen Maytham
      • Lévis, Canada, G6V 0C9
        • Recruiting
        • Alpha Recherche Clinique - Lévis
        • Contact:
          • Phone Number: 418-380-1112
        • Principal Investigator:
          • Steeve Kwan Tat
      • Oakville, Canada, L6H 3P1
        • Recruiting
        • The Fe/Male Health Centre
        • Contact:
          • Phone Number: 1 905 842 1393
        • Principal Investigator:
          • Richard Casey
      • Québec, Canada, G3K 2P8
        • Recruiting
        • ALPHA Recherche Clinique
        • Principal Investigator:
          • Camille Walsh
        • Contact:
          • Phone Number: 418-847-1112
      • Québec, Canada, G2J 0C4
        • Recruiting
        • ALPHA Recherche Clinique
        • Principal Investigator:
          • Jonathan Cloutier
      • Red Deer, Canada, T4P 1K4
        • Recruiting
        • CaRe Clinic
        • Contact:
          • Phone Number: 1-587-797-4443
        • Principal Investigator:
          • Josias Badenhorst
      • Toronto, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute
        • Principal Investigator:
          • Sender Herschorn
  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Principal Investigator:
          • Shijun Wang
      • Beijing, China, 100091
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Hongyan Guo
      • Beijing, China, 100034
        • Recruiting
        • Peking University People's Hospital
        • Principal Investigator:
          • Xin Yang
      • Beijing, China, 100032
        • Recruiting
        • Peking University First Hospital
        • Principal Investigator:
          • Ye Lu
      • Chengdu, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Jie Mei
      • Chengdu, China, 610091
        • Recruiting
        • Chengdu Women and Children Center Hospital
        • Principal Investigator:
          • Li He
      • Chongqing, China, 400010
        • Recruiting
        • 2nd Affiliated Hospital Chongqing Medical University
        • Principal Investigator:
          • Lina Hu
      • Guangzhou, China, 510280
        • Recruiting
        • Zhujiang Hospital
        • Principal Investigator:
          • A'Bai Xu
      • Guangzhou, China, 510630
        • Recruiting
        • The First Affiliated Hospital of Jinan University
        • Principal Investigator:
          • Yuan Shen
      • Hangzhou, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Principal Investigator:
          • Huafeng Shou
      • Hefei, China, 230000
        • Recruiting
        • Second Affiliated Hospital of Anhui Medical University
        • Principal Investigator:
          • dexin yu
        • Contact:
          • Phone Number: 0551-65997147
      • Lanzhou, China, 730000
        • Recruiting
        • Gansu Provincial Hospital
        • Principal Investigator:
          • Xiande Huang
      • Nanjing, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
        • Principal Investigator:
          • Hongqian Guo
      • Ningbo, China, 315010
        • Recruiting
        • Ningbo First Hospital
        • Contact:
          • Phone Number: 15958800971
        • Principal Investigator:
          • Qi Ma
      • Shanghai, China, 200011; 200090
        • Recruiting
        • Obstetrics & Gynecology Hospital of Fudan University
        • Contact:
          • Phone Number: 15026585241
        • Principal Investigator:
          • Xiaofang Yi
      • Shenzhen, China, 518036
        • Recruiting
        • Peking University Shenzhen Hospital
        • Principal Investigator:
          • Changzhong Li
      • Suzhou, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Weipei Zhu
      • Wuhan, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Phone Number: 13971618220
        • Principal Investigator:
          • Xiaoyi Yuan
      • Xi'an, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Xudong Li
      • Xiamen, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Principal Investigator:
          • Qionghua Chen
      • Yinchuan, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Principal Investigator:
          • Chunfang Ha
  • Czechia
      • Benešov, Czechia, 256 01
        • Recruiting
        • Afimed - Urologicka ambulance
        • Contact:
          • Phone Number: 00420777837971
        • Principal Investigator:
          • Ales Fiala
      • Brno, Czechia, 603 00
        • Recruiting
        • Gynekologie Šottner
        • Principal Investigator:
          • Oldrich Sottner
      • Karlovy Vary, Czechia, 360 17
        • Recruiting
        • Centrum Panevniho Dna
        • Contact:
          • Phone Number: 00420777067699
        • Principal Investigator:
          • Vladimir Kalis
      • Náchod, Czechia, 547 01
        • Recruiting
        • Kestr-gyn
        • Contact:
          • Phone Number: +420 491 421 883
        • Principal Investigator:
          • Jan Kestranek
      • Olomouc, Czechia, 772 00
        • Recruiting
        • G-CENTRUM Olomouc
        • Contact:
          • Phone Number: 420585854444
        • Principal Investigator:
          • Ales Skrivanek
      • Olomouc, Czechia, 779 00
        • Recruiting
        • NEUMED gynekologická ambulance
        • Principal Investigator:
          • David Neubert
      • Ostrava, Czechia, 709 00
        • Recruiting
        • GYNORD plus
        • Contact:
          • Phone Number: +420602575974
        • Principal Investigator:
          • Martina Vortelova Baricakova
      • Pilsen, Czechia, 301 00
        • Recruiting
        • Gyncare
        • Contact:
          • Phone Number: 00420 602 336 616
        • Principal Investigator:
          • Michael Svec
      • Prague, Czechia, 110 00
        • Recruiting
        • Nestátní zdravotnické zařízení GONA
        • Contact:
          • Phone Number: 00420602327122
        • Principal Investigator:
          • Lukas Horcicka
  • India
      • Ahmedabad, India, 380013
        • Not yet recruiting
        • Devasya Superspeciality Kidney & Multispeciality Hospitals
        • Principal Investigator:
          • Dinesh Patel
      • Ahmedabad, India, 382428
        • Not yet recruiting
        • Apollo Hospitals Ahmedabad
        • Principal Investigator:
          • Dhruv Patel
      • Belagavi, India, 590010
        • Not yet recruiting
        • KLES Dr. Prabhakar Kore Hospital & M.R.C
        • Principal Investigator:
          • Dr. Vikram Prabha
      • Belgavi, India, 590019
        • Not yet recruiting
        • Belagavi Institute of Medical Sciences - Belagavi
        • Principal Investigator:
          • Mahantesh Todakar
      • Bhubaneswar, India, 751019
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Sambit Tripathy
      • Chandigarh, India, 160012
        • Not yet recruiting
        • Postgraduate Institute of Medical Education & Research
        • Principal Investigator:
          • Girdhar Bora
      • Chennai, India, 600006
        • Not yet recruiting
        • Apollo Hospitals - Chennai
        • Contact:
          • Phone Number: 09488648574
        • Principal Investigator:
          • Meera Ragavan
      • Hyderabad, India, 500055
        • Not yet recruiting
        • Malla Reddy Narayana Multispeciality Hospital
        • Principal Investigator:
          • Gopi Kishore Meda
      • Nagpur, India, 440012
        • Not yet recruiting
        • Ketki Nursing Home & Urology Hospital
        • Contact:
          • Phone Number: 9822041307
        • Principal Investigator:
          • Sadashiv Bhole
      • New Delhi, India, 110060
        • Not yet recruiting
        • Sir Ganga Ram Hospital
        • Principal Investigator:
          • Vipin Tyagi
      • Pune, India, 411057
        • Not yet recruiting
        • Lifepoint Multispeciality Hospital
        • Contact:
          • Phone Number: 02066434366
        • Principal Investigator:
          • Sagar Bhalerao
      • Raipur, India, 492099
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Amit Sharma
        • Contact:
          • Phone Number: +91 8691898668
      • Rishikesh, India, 249203
        • Not yet recruiting
        • All India Institute of Medical Sciences - Rishikesh
        • Principal Investigator:
          • Ankur Mittal
      • Surat, India, 395002
        • Not yet recruiting
        • Surat Institute of Digestive Sciences Hospitals
        • Principal Investigator:
          • Jignesh Ghevariya
      • Varanasi, India, 221005
        • Not yet recruiting
        • Banaras Hindu University
        • Contact:
          • Phone Number: +919839861656
        • Principal Investigator:
          • Sameer Trivedi
  • Japan
      • Arakawa City, Japan, 116-0014
        • Recruiting
        • Hasegawa Hospital - Arakawa
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroyuki Shimizu
      • Chiba, Japan, 261-0004
        • Recruiting
        • Takasu Nephrology and Urology Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takeshi Shichijo
      • Chiyoda City, Japan, 102-0084
        • Recruiting
        • Yotsuya Medical Cube
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • shimoinaba misa
      • Chūōku, Japan, 104-8560
        • Recruiting
        • St. Luke's International Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazutaka Narimoto
      • Higashiibaraki, Japan, 311-3117
        • Recruiting
        • Mito Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masahiro Iinuma
      • Itabashiku, Japan, 173-8610
        • Recruiting
        • Nihon University Itabashi Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tsuyoshi Yoshizawa
      • Kitakyushu, Japan, 802-8555
        • Recruiting
        • Kokura Memorial Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shigeru Sakano
      • Matsudo, Japan, 270-0034
        • Recruiting
        • Touyu Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masahiko Suzuki
      • Minatoku, Japan, 108-0073
        • Recruiting
        • Tokyo Saiseikai Central Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroki Ide
      • Nagoya, Japan, 457-8511
        • Recruiting
        • Koujunkai Daido Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroyuki Kamiya
      • Naka-ku, Yokohama-Shi, Japan, 231-0861
        • Recruiting
        • Women's Clinic LUNA NEXT STAGE
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • YUKI SEKIGUCHI
      • Narashino, Japan, 275-8580
        • Recruiting
        • Chiba Saiseikai Narashino hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazuo Mikami
      • Nonoichi, Japan, 921-8824
        • Recruiting
        • Nakazawa Nephrology and Urology Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yusuke Nakazawa
      • Okayama, Japan, 700-0822
        • Recruiting
        • Miyabi Urogyne Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Miyabi Inoue
      • Osaka, Japan, 530-0012
        • Recruiting
        • Nakatsu Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hirofumi Uehara
      • Saitama-shi, Japan, 330-0855
        • Recruiting
        • Kashiwazaki Obstetrics and Gynecology Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuji Kashiwazaki
      • Sendai, Japan, 981-3121
        • Recruiting
        • Izumi Chuo Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Haruo Nakagawa
      • Toride, Japan, 302-0021
        • Recruiting
        • Toride Urology Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • YUKIHIDE MATSUI
      • Tsukuba, Japan, 305-0821
        • Recruiting
        • Tsukuba Urocare Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tingwen Huang
      • Ōta-ku, Japan, 145-0065
        • Recruiting
        • Yukigaya Urology Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ken Miyama
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Recruiting
        • Scientia Investigacion Clinica S.C.
        • Principal Investigator:
          • Ruben Gonzales
      • Chihuahua City, Mexico, 31110
        • Recruiting
        • Medical Center Metas
        • Principal Investigator:
          • Luis Nevarez
        • Contact:
          • Phone Number: 52 614 423 5956
      • Ciudad Madero, Mexico, 89440
        • Recruiting
        • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
        • Contact:
          • Phone Number: 528331260055
        • Principal Investigator:
          • Salvador Mojarro Bazán
      • Juriquilla, Mexico, 76230
        • Recruiting
        • Health Pharma Querétaro
        • Contact:
          • Phone Number: 4622209643
        • Principal Investigator:
          • Manuel Belmonte Chico Goerne
      • Mexico City, Mexico, 03330
        • Not yet recruiting
        • Centro de Oncología de Precisión - Mexico City
        • Contact:
          • Phone Number: +525591334607
        • Principal Investigator:
          • Sergio Contreras
      • Mexico City, Mexico, 03100
        • Recruiting
        • RM Pharma Specialists - Unidad Especializada en Datos
        • Principal Investigator:
          • Juan Jose Morales Virgen
        • Contact:
          • Phone Number: 5518669106
      • Mexico City, Mexico, 14308
        • Recruiting
        • Quemex Medical and Research
        • Contact:
          • Phone Number: 5215537225772
        • Principal Investigator:
          • RODRIGO PEREZ
      • Monterrey, Mexico, 66465
        • Recruiting
        • Centro de investigación y control metabólico
        • Principal Investigator:
          • Jorge Acosta Rodriguez
      • Monterrey, Mexico, 64060
        • Not yet recruiting
        • Jose Gerardo Garza Leal
        • Principal Investigator:
          • Jose Garza Leal
      • Morelia, Mexico, 58260
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Contact:
          • Phone Number: 4431478545
        • Principal Investigator:
          • Alejandra Murillo
      • Mérida, Mexico, 97070
        • Recruiting
        • Medical Care and Research SA de CV
        • Principal Investigator:
          • Esteban Aguilar Vargas
      • México, Mexico, 06700
        • Not yet recruiting
        • Clinstile, S.A. de C.V.
        • Principal Investigator:
          • Viktor Kibanov Solomonov
      • Tlalpan, Mexico, 14050
        • Recruiting
        • Medimanage Research
        • Principal Investigator:
          • RICARDO CASTILLEJOS-MOLINA
  • Poland
      • Bydgoszcz, Poland, 85-048
        • Recruiting
        • IN VIVO
        • Contact:
          • Phone Number: 501109918
        • Principal Investigator:
          • Piotr Piasecki
      • Skórzewo, Poland, 60-185
        • Recruiting
        • AIDPORT Sp. z o.o.
        • Principal Investigator:
          • Krzysztof Szymanowski
        • Contact:
          • Phone Number: 570783100
      • Szczecin, Poland, 70-111
        • Recruiting
        • Centrum Medyczne Euromedis
        • Principal Investigator:
          • Michal Soczawa
      • Warsaw, Poland, 02-798
        • Recruiting
        • Medical Concierge Centrum Medyczne
        • Principal Investigator:
          • Piotr Radziszewski
        • Contact:
          • Phone Number: 602300992
      • Wroclaw, Poland, 50-414
        • Recruiting
        • Centrum Medyczne Ginemedica
        • Principal Investigator:
          • Anna Szwabowicz
      • Wroclaw, Poland, 54-239
        • Recruiting
        • EMC Instytut Medyczny SA
        • Principal Investigator:
          • Rafal Kmieciak
  • Romania
      • Brasov, Romania, 500091
        • Recruiting
        • Centrul Medical Unirea
        • Contact:
          • Phone Number: 0745.326.790
        • Principal Investigator:
          • Marius Neculoiu
      • Brasov, Romania, 500152
        • Recruiting
        • Spitalul Clinic Judetean de Urgenta (Brasov)
        • Contact:
          • Phone Number: 0722332622
        • Principal Investigator:
          • Ioan Scarneciu
      • Bucharest, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute
        • Contact:
          • Phone Number: 0721266866
        • Principal Investigator:
          • Robert Stoica
      • Bucharest, Romania, 020125
        • Recruiting
        • Spitalul Clinic Colentina
        • Contact:
          • Phone Number: +40751109312
        • Principal Investigator:
          • Mihail Dragutescu
      • Bucharest, Romania, 014142
        • Recruiting
        • Delta Health Care
        • Contact:
          • Phone Number: 0751.109.315
        • Principal Investigator:
          • Dragos Georgescu
      • Bucharest, Romania, 010825
        • Not yet recruiting
        • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
        • Principal Investigator:
          • Victor Madan
      • Bucharest, Romania, 050659
        • Recruiting
        • Spitalul Clinic Profesor Doctor Theodor Burghele
        • Contact:
          • Phone Number: +407227432634
        • Principal Investigator:
          • Viorel Jinga
      • Bucharest, Romania, 010731
        • Recruiting
        • Spitalul Clinic de Nefrologie Doctor Carol Davila
        • Contact:
          • Phone Number: 0040726137573
        • Principal Investigator:
          • Mihai Dumitrache
      • Bucharest, Romania, 021373
        • Recruiting
        • Spitalul de Urgenta al Ministerului Administratiei si Internelor "Prof. Dr. Dimitrie Gerota"
        • Contact:
          • Phone Number: 0742062248
        • Principal Investigator:
          • Catalin Belinski
      • Bucharest, Romania, 022105
        • Recruiting
        • Spitalul Clinic Județean de Urgență Ilfov
        • Contact:
          • Phone Number: 0721551492
        • Principal Investigator:
          • Alexandru Mihalache
      • Bucharest, Romania, 030913
        • Recruiting
        • Gnosis Evomed S.R.L.
        • Principal Investigator:
          • Andrei Manu Marin
      • Craiova, Romania, 200642
        • Recruiting
        • Spitalul Clinic Județean de Urgență
        • Contact:
          • Phone Number: +40745606257
        • Principal Investigator:
          • Octavian Dragoescu
      • Oradea, Romania, 410169
        • Recruiting
        • Spitalul Clinic Judetean de Urgenta Bihor
        • Contact:
          • Phone Number: 0040753056452
        • Principal Investigator:
          • Mihail-Claudius Berechet
      • Sibiu, Romania, 550253
        • Not yet recruiting
        • Clinica Polisano
        • Contact:
          • Phone Number: 0040729899034
        • Principal Investigator:
          • Valentin Pirvut
      • Suceagu, Romania, 407062
        • Recruiting
        • Polaris Medical SA
        • Contact:
          • Phone Number: 0742059395
        • Principal Investigator:
          • Nicolae Crisan
      • Timișoara, Romania, 300723
        • Recruiting
        • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
        • Contact:
          • Phone Number: 40723307888
        • Principal Investigator:
          • Razvan Bardan
      • Timișoara, Romania, 300645
        • Recruiting
        • S.C. Materna Care S.R.L.
        • Contact:
          • Phone Number: 0722799219
        • Principal Investigator:
          • Cristian Condoiu
  • South Korea
      • Anyang-si, South Korea, 14068
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Principal Investigator:
          • Cheol Young Oh
      • Bucheon-si, South Korea, 14647
        • Recruiting
        • The Catholic University of Korea, Bucheon St. Mary's Hospital
        • Principal Investigator:
          • Joon Chul Kim
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
        • Principal Investigator:
          • DONG GIL SHIN
      • Gwangju, South Korea, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
          • Phone Number: 82-62-220-6710
        • Principal Investigator:
          • Sun-Ouck Kim
      • Junggu, South Korea, 41944
        • Recruiting
        • Kyungpook National University Hospital
        • Principal Investigator:
          • EUNSANG YOO
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Jang Hwan Kim
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • KYU-SUNG LEE
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama -The Kirklin Clinic
        • Principal Investigator:
          • Gabriela Halder
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • AMR Clinical
        • Principal Investigator:
          • Danilo Herrera
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Urologic Surgeons of Arizona
        • Principal Investigator:
          • Kashif Alvi
    • California
      • Los Angeles, California, United States, 90057
        • Recruiting
        • Matrix Clinical Research
        • Contact:
          • Phone Number: 310-424-5922
        • Principal Investigator:
          • Peyman Banooni
      • Montebello, California, United States, 90640
        • Recruiting
        • Alarcon Urology Center
        • Principal Investigator:
          • Juan Alarcon
      • Tustin, California, United States, 92780
        • Recruiting
        • Prestige Medical Group
        • Principal Investigator:
          • Lamia Gabal
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Colorado Clinical Research
        • Contact:
          • Phone Number: 303-996-9649
        • Principal Investigator:
          • David Cahn
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • AMR Clinical
        • Contact:
          • Phone Number: 239-936-4421
        • Principal Investigator:
          • Kevin Fleishman
      • Lake Worth, Florida, United States, 33461
        • Recruiting
        • Altus Research
        • Principal Investigator:
          • Samuel Lederman
        • Contact:
          • Phone Number: 561-641-0404
      • Miami, Florida, United States, 33186
        • Recruiting
        • New Age Medical Research Corporation
        • Contact:
          • Phone Number: 305-596-9901
        • Principal Investigator:
          • Joanna Bedell
      • Panama City, Florida, United States, 32405
        • Recruiting
        • Emerald Coast OBGYN Clinical Research
        • Principal Investigator:
          • Samuel Wolf
    • Georgia
      • Lawrenceville, Georgia, United States, 30043
        • Recruiting
        • Teak Research Consults
        • Principal Investigator:
          • Kamar Alabi
    • Michigan
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
        • Contact:
          • Phone Number: 248-312-0025
        • Principal Investigator:
          • Neil Fraser
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Recruiting
        • OB/GYN Associates of Erie
        • Principal Investigator:
          • Michael Scutella
      • Philadelphia, Pennsylvania, United States, 19114
        • Recruiting
        • Clinical Research of Philadelphia
        • Principal Investigator:
          • Eugene Andruczyk
        • Contact:
          • Phone Number: 215-676-6696
    • Texas
      • Houston, Texas, United States, 77057
        • Recruiting
        • Next Level Urgent Care
        • Principal Investigator:
          • Wilner Jeudy
        • Contact:
          • Phone Number: 832-460-3311
      • Houston, Texas, United States, 77065
        • Recruiting
        • Innovative Medical Research of Texas
        • Principal Investigator:
          • Karyn Cumberbatch
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Health Research of Hampton Roads, Inc.
        • Contact:
          • Phone Number: 757-591-8100
        • Principal Investigator:
          • George Freeman
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Urology of Virginia
        • Principal Investigator:
          • Kurt McCammon
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
          • Phone Number: 877-453-0404
        • Principal Investigator:
          • Ann Kolwitz
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Seattle Clinical Research Center
        • Contact:
          • Phone Number: 206-522-3330
        • Principal Investigator:
          • Rebecca Dunsmoor-Su

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orforglipron (GZS1)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Placebo Comparator: Placebo (GZS1)
Participants will receive placebo orally
Drug: Placebo
Administered orally
Experimental: Orforglipron (GZS2)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Placebo Comparator: Placebo (GZS2)
Participants will receive placebo orally
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Urinary Incontinence-Specific Quality of Life
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Number of Continence Pad (CAPD) Used Per Week
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Patient Global Impression of Condition
Time Frame: Baseline, Week 52
Baseline, Week 52
Percent Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 52
Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

September 24, 2025

First Posted (Actual)

October 2, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27672
  • 2025-522514-23-00 (Ctis)
  • J2A-MC-GZPS (Other Identifier: Eli Lilly and Company)
  • J2A-MC-GZS1 (Other Identifier: Eli Lilly and Company)
  • J2A-MC-GZS2 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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