A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
RESTRAIN-SUI
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
5 other identifiers
interventional
1,000
10 countries
136
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
136 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2025
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedFirst Posted
Study publicly available on registry
October 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
April 17, 2026
April 1, 2026
2.4 years
September 24, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Incontinence Episode Frequency (IEF)
Baseline, Week 52
Secondary Outcomes (6)
Percent Change from Baseline in Body Weight
Baseline, Week 52
Change from Baseline in Urinary Incontinence-Specific Quality of Life
Baseline, Week 52
Change from Baseline in Number of Continence Pad (CAPD) Used Per Week
Baseline, Week 52
Change from Baseline in Patient Global Impression of Condition
Baseline, Week 52
Percent Change from Baseline in Total Cholesterol
Baseline, Week 52
- +1 more secondary outcomes
Study Arms (4)
Orforglipron (GZS1)
EXPERIMENTALParticipants will receive orforglipron orally
Placebo (GZS1)
PLACEBO COMPARATORParticipants will receive placebo orally
Orforglipron (GZS2)
EXPERIMENTALParticipants will receive orforglipron orally
Placebo (GZS2)
PLACEBO COMPARATORParticipants will receive placebo orally
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (136)
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 First Hospital
Beijing, 100032, China
Peking University People's Hospital
Beijing, 100034, China
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Peking University Third Hospital
Beijing, 100091, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2025
First Posted
October 2, 2025
Study Start
September 30, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.