Urinary Incontinence,StressPhase 3RESTRAIN-SUINCT07202884
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
A Phase 3 study testing Orforglipron in people with Urinary Incontinence,Stress, run by Eli Lilly and Company at 136 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- Orforglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 136 sitesin 10 countries
- Study dates
- 30 Sep 2025to Mar 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
136 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
136 sites in 10 countries
United States21 sites, 20 recruiting
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
877-453-0404
Ann Kolwitz
- Recruiting
University of Alabama -The Kirklin Clinic
Birmingham, Alabama, 35233
Gabriela Halder
- Recruiting
OB/GYN Associates of Erie
Erie, Pennsylvania, 16507
Michael Scutella
- Recruiting
AMR Clinical
Fort Myers, Florida, 33912
239-936-4421
Kevin Fleishman
- Recruiting
Next Level Urgent Care
Houston, Texas, 77057
832-460-3311
Wilner Jeudy
- Recruiting
Innovative Medical Research of Texas
Houston, Texas, 77065
Karyn Cumberbatch
- Recruiting
Altus Research
Lake Worth, Florida, 33461
561-641-0404
Samuel Lederman
- Recruiting
Colorado Clinical Research
Lakewood, Colorado, 80228
303-996-9649
David Cahn
- Recruiting
Teak Research Consults
Lawrenceville, Georgia, 30043
Kamar Alabi
- Recruiting
Matrix Clinical Research
Los Angeles, California, 90057
310-424-5922
Peyman Banooni
- Not yet recruiting
Urologic Surgeons of Arizona
Mesa, Arizona, 85206
Kashif Alvi
- Recruiting
New Age Medical Research Corporation
Miami, Florida, 33186
305-596-9901
Joanna Bedell
- Recruiting
AMR Clinical
Mobile, Alabama, 36608
Danilo Herrera
- Recruiting
Alarcon Urology Center
Montebello, California, 90640
Juan Alarcon
- Recruiting
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
757-591-8100
George Freeman
- Recruiting
Emerald Coast OBGYN Clinical Research
Panama City, Florida, 32405
Samuel Wolf
- Not yet recruiting
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
215-676-6696
Eugene Andruczyk
- Recruiting
Seattle Clinical Research Center
Seattle, Washington, 98104
206-522-3330
Rebecca Dunsmoor-Su
- Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
248-312-0025
Neil Fraser
- Completed
Prestige Medical Group
Tustin, California, 92780
- Recruiting
Urology of Virginia
Virginia Beach, Virginia, 23462
Kurt McCammon
China21 sites, 21 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100032
Xin Yang
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, 100053
Shijun Wang
- Recruiting
Peking University Third Hospital
Beijing, 100091
Hongyan Guo
- Recruiting
Peking University First Hospital
Beijing, 102600
Ye Lu
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Jie Mei
- Recruiting
Chengdu Women and Children Center Hospital
Chengdu, 610091
Li He
- Recruiting
2nd Affiliated Hospital Chongqing Medical University
Chongqing, 400010
Lina Hu
- Recruiting
Zhujiang Hospital
Guangzhou, 510280
A'Bai Xu
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, 510630
Yuan Shen
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Huafeng Shou
- Recruiting
Second Affiliated hospital of Anhui Medical University
Hefei, 230000
0551-65997147
dexin yu
- Recruiting
Gansu Provincial Hospital
Lanzhou, 730000
Xiande Huang
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210000
Hongqian Guo
- Recruiting
Ningbo First Hospital
Ningbo, 315010
15958800971
Qi Ma
- Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, 200011; 200090
15026585241
Xiaofang Yi
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, 518036
Changzhong Li
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
Weipei Zhu
- Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030
13971618220
Xiaoyi Yuan
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
Xudong Li
- Recruiting
The First Affiliated hospital of Xiamen University
Xiamen, 361003
Qionghua Chen
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, 750004
Chunfang Ha
Japan20 sites, 20 recruiting
- Recruiting
Hasegawa Hospital - Arakawa
Arakawa City, 116-0014
81120023812
Hiroyuki Shimizu
- Recruiting
Takasu Nephrology and Urology Clinic
Chiba, 261-0004
81120023812
Takeshi Shichijo
- Recruiting
Yotsuya Medical Cube
Chiyoda City, 102-0084
81120023812
shimoinaba misa
- Recruiting
St. Luke's International Hospital
Chūōku, 104-8560
81120023812
Kazutaka Narimoto
- Recruiting
Mito Medical Center
Higashiibaraki, 311-3117
81120023812
Masahiro Iinuma
- Recruiting
Nihon University Itabashi Hospital
Itabashiku, 173-8610
81120023812
Tsuyoshi Yoshizawa
- Recruiting
Kokura Memorial Hospital
Kitakyushu, 802-8555
81120023812
Shigeru Sakano
- Recruiting
Touyu Clinic
Matsudo, 270-0034
81120023812
Masahiko Suzuki
- Recruiting
Tokyo Saiseikai Central Hospital
Minatoku, 108-0073
81120023812
Hiroki Ide
- Recruiting
Koujunkai Daido Clinic
Nagoya, 457-8511
81120023812
Hiroyuki Kamiya
- Recruiting
Women's Clinic LUNA NEXT STAGE
Naka-ku, Yokohama-Shi, 231-0861
81120023812
YUKI SEKIGUCHI
- Recruiting
Chiba Saiseikai Narashino hospital
Narashino, 275-8580
81120023812
Kazuo Mikami
- Recruiting
Nakazawa Nephrology and Urology Clinic
Nonoichi, 921-8824
81120023812
Yusuke Nakazawa
- Recruiting
Miyabi Urogyne Clinic
Okayama, 700-0822
81120023812
Miyabi Inoue
- Recruiting
Nakatsu Hospital
Osaka, 530-0012
81120023812
Hirofumi Uehara
- Recruiting
Yukigaya Urology Clinic
Ōta-ku, 145-0065
81120023812
Ken Miyama
- Recruiting
Kashiwazaki Obstetrics and Gynecology Clinic
Saitama-shi, 330-0855
81120023812
Yuji Kashiwazaki
- Recruiting
Izumi Chuo Hospital
Sendai, 981-3121
81120023812
Haruo Nakagawa
- Recruiting
Toride Urology Clinic
Toride, 302-0021
81120023812
YUKIHIDE MATSUI
- Recruiting
Tsukuba Urocare Clinic
Tsukuba, 305-0821
81120023812
Tingwen Huang
Romania16 sites, 16 recruiting
- Recruiting
Centrul Medical Unirea
Brasov, 500091
0745.326.790
Marius Neculoiu
- Recruiting
Spitalul Clinic Judetean de Urgenta (Brasov)
Brasov, 500152
0722332622
Ioan Scarneciu
- Recruiting
Spitalul Clinic de Nefrologie Doctor Carol Davila
Bucharest, 010731
0040726137573
Mihai Dumitrache
- Recruiting
Delta Health Care
Bucharest, 014142
0751.109.315
Dragos Georgescu
- Recruiting
Spitalul Clinic Colentina
Bucharest, 020125
+40751109312
Mihail Dragutescu
- Recruiting
Spitalul de Urgenta al Ministerului Administratiei si Internelor "Prof. Dr. Dimitrie Gerota"
Bucharest, 021373
0742062248
Catalin Belinski
- Recruiting
Spitalul Clinic Județean de Urgență Ilfov
Bucharest, 022105
0721551492
Alexandru Mihalache
- Recruiting
Fundeni Clinical Institute
Bucharest, 022328
0721266866
Robert Stoica
- Recruiting
Gnosis Evomed S.R.L.
Bucharest, 030913
Andrei Manu Marin
- Recruiting
Spitalul Clinic Profesor Doctor Theodor Burghele
Bucharest, 050659
+407227432634
Viorel Jinga
- Recruiting
Spitalul Clinic Județean de Urgență
Craiova, 200642
+40745606257
Octavian Dragoescu
- Recruiting
Spitalul Clinic Judetean De Urgenta Bihor
Oradea, 410169
0040753056452
Mihail-Claudius Berechet
- Recruiting
Clinica Polisano
Sibiu, 550253
0040729899034
Valentin Pirvut
- Recruiting
Polaris Medical SA
Suceagu, 407062
0742059395
Nicolae Crisan
- Recruiting
S.C. Materna Care S.R.L.
Timișoara, 300645
0722799219
Cristian Condoiu
- Recruiting
Spitalul Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara
Timișoara, 300723
40723307888
Razvan Bardan
India15 sites, 15 recruiting
- Not yet recruiting
Devasya Superspeciality Kidney & Multispeciality Hospitals
Ahmedabad, 380013
Dinesh Patel
- Not yet recruiting
Apollo Hospitals Ahmedabad
Ahmedabad, 382428
Dhruv Patel
- Not yet recruiting
KLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi, 590010
Dr. Vikram Prabha
- Not yet recruiting
Belagavi Institute of Medical Sciences - Belagavi
Belgavi, 590019
Mahantesh Todakar
- Not yet recruiting
All India Institute of Medical Sciences
Bhubaneswar, 751019
Sambit Tripathy
- Not yet recruiting
Postgraduate Institute of Medical Education & Research
Chandigarh, 160012
Girdhar Bora
- Not yet recruiting
Apollo Hospitals - Chennai
Chennai, 600006
09488648574
Meera Ragavan
- Not yet recruiting
Malla Reddy Narayana Multispeciality Hospital
Hyderabad, 500055
Gopi Kishore Meda
- Not yet recruiting
Ketki Nursing Home & Urology Hospital
Nagpur, 440012
9822041307
Sadashiv Bhole
- Not yet recruiting
Sir Ganga Ram Hospital
New Delhi, 110060
Vipin Tyagi
- Not yet recruiting
Lifepoint Multispeciality Hospital
Pune, 411057
02066434366
Sagar Bhalerao
- Not yet recruiting
All India Institute of Medical Sciences
Raipur, 492099
+91 8691898668
Amit Sharma
- Not yet recruiting
All India Institute of Medical Sciences - Rishikesh
Rishikesh, 249203
Ankur Mittal
- Not yet recruiting
Surat Institute of Digestive Sciences Hospitals
Surat, 395002
Jignesh Ghevariya
- Not yet recruiting
Banaras Hindu University
Varanasi, 221005
+919839861656
Sameer Trivedi
Mexico13 sites, 13 recruiting
- Recruiting
Medical Center Metas
Chihuahua City, 31110
52 614 423 5956
Luis Nevarez
- Recruiting
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Ruben Gonzales
- Recruiting
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, 89440
528331260055
Salvador Mojarro Bazán
- Recruiting
Health Pharma Querétaro
Juriquilla, 76230
4622209643
Manuel Belmonte Chico Goerne
- Recruiting
Medical Care and Research SA de CV
Mérida, 97070
Esteban Aguilar Vargas
- Not yet recruiting
Clinstile, S.A. de C.V.
México, 06700
Viktor Kibanov Solomonov
- Recruiting
RM Pharma Specialists - Unidad Especializada en Datos
Mexico City, 03100
5518669106
Juan Jose Morales Virgen
- Not yet recruiting
Centro de Oncología de Precisión - Mexico City
Mexico City, 03330
+525591334607
Sergio Contreras
- Recruiting
Quemex Medical and Research
Mexico City, 14308
5215537225772
RODRIGO PEREZ
- Not yet recruiting
Jose Gerardo Garza Leal
Monterrey, 64060
Jose Garza Leal
- Recruiting
Centro de investigación y control metabólico
Monterrey, 66465
Jorge Acosta Rodriguez
- Not yet recruiting
Centro de Investigacion Clinica Chapultepec
Morelia, 58260
4431478545
Alejandra Murillo
- Recruiting
Medimanage Research
Tlalpan, 14050
RICARDO CASTILLEJOS-MOLINA
Czechia9 sites, 9 recruiting
- Recruiting
Afimed - Urologicka ambulance
Benešov, 256 01
00420777837971
Ales Fiala
- Recruiting
Gynekologie Šottner
Brno, 603 00
Oldrich Sottner
- Recruiting
Centrum Panevniho Dna
Karlovy Vary, 360 17
00420777067699
Vladimir Kalis
- Recruiting
Kestr-gyn
Náchod, 547 01
+420 491 421 883
Jan Kestranek
- Recruiting
G-CENTRUM Olomouc
Olomouc, 772 00
420585854444
Ales Skrivanek
- Recruiting
NEUMED gynekologická ambulance
Olomouc, 779 00
David Neubert
- Recruiting
GYNORD plus
Ostrava, 709 00
+420602575974
Martina Vortelova Baricakova
- Recruiting
Gyncare
Pilsen, 301 00
00420 602 336 616
Michael Svec
- Recruiting
Nestátní zdravotnické zařízení GONA
Prague, 110 00
00420602327122
Lukas Horcicka
Canada8 sites, 8 recruiting
- Recruiting
OCT Research ULC
Kelowna, V1Y 1Z9
250-862-8141
Mallory Myers
- Recruiting
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Colleen Maytham
- Recruiting
Alpha Recherche Clinique - Lévis
Lévis, G6V 0C9
418-380-1112
Steeve Kwan Tat
- Recruiting
The Fe/Male Health Centre
Oakville, L6H 3P1
1 905 842 1393
Richard Casey
- Recruiting
Alpha Recherche Clinique
Québec, G2J 0C4
Jonathan Cloutier
- Recruiting
ALPHA Recherche Clinique
Québec, G3K 2P8
418-847-1112
Camille Walsh
- Recruiting
CaRe Clinic
Red Deer, T4P 1K4
1-587-797-4443
Josias Badenhorst
- Recruiting
Sunnybrook Research Institute
Toronto, M4N 3M5
Sender Herschorn
South Korea7 sites, 7 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si, 14068
Cheol Young Oh
- Recruiting
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, 14647
Joon Chul Kim
- Recruiting
Pusan National University Hospital
Busan, 49241
DONG GIL SHIN
- Recruiting
Chonnam National University Hospital
Gwangju, 61469
82-62-220-6710
Sun-Ouck Kim
- Recruiting
Kyungpook National University Hospital
Junggu, 41944
EUNSANG YOO
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Jang Hwan Kim
- Recruiting
Samsung Medical Center
Seoul, 06351
KYU-SUNG LEE
Poland6 sites, 6 recruiting
- Recruiting
IN VIVO
Bydgoszcz, 85-048
501109918
Piotr Piasecki
- Recruiting
AIDPORT Sp. z o.o.
Skórzewo, 60-185
570783100
Krzysztof Szymanowski
- Recruiting
Centrum Medyczne Euromedis
Szczecin, 70-111
Michal Soczawa
- Recruiting
Medical Concierge Centrum Medyczne
Warsaw, 02-798
602300992
Piotr Radziszewski
- Recruiting
Centrum Medyczne Ginemedica
Wroclaw, 50-414
Anna Szwabowicz
- Recruiting
EMC Instytut Medyczny SA
Wroclaw, 54-239
Rafal Kmieciak
About this study
Official title: 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.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- Orforglipron, Placebo
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrforglipronDrug
Also called LY3502970
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Orforglipron (GZS1) | Experimental | Participants will receive orforglipron orally Receives: Drug: Orforglipron |
| Placebo (GZS1) | Placebo comparator | Participants will receive placebo orally Receives: Drug: Placebo |
| Orforglipron (GZS2) | Experimental | Participants will receive orforglipron orally Receives: Drug: Orforglipron |
| Placebo (GZS2) | Placebo comparator | Participants will receive placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Incontinence Episode Frequency (IEF)
Measured: Baseline, Week 52
Secondary outcomes (6)
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 52
Change from Baseline in Urinary Incontinence-Specific Quality of Life
Measured: Baseline, Week 52
Change from Baseline in Number of Continence Pad (CAPD) Used Per Week
Measured: Baseline, Week 52
Change from Baseline in Patient Global Impression of Condition
Measured: Baseline, Week 52
Percent Change from Baseline in Total Cholesterol
Measured: Baseline, Week 52
Change from Baseline in Waist Circumference
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start30 Sep 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202884
- Sponsor's protocol ID
- 27672
- Other IDs
- 2025-522514-23-00, J2A-MC-GZPS, J2A-MC-GZS1, J2A-MC-GZS2, 2025
- Acronym
- RESTRAIN-SUI
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.