A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
NCT ID: NCT07202884
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2025-09-30
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Orforglipron (GZS1)
Participants will receive orforglipron orally
Orforglipron
Administered orally
Placebo (GZS1)
Participants will receive placebo orally
Placebo
Administered orally
Orforglipron (GZS2)
Participants will receive orforglipron orally
Orforglipron
Administered orally
Placebo (GZS2)
Participants will receive placebo orally
Placebo
Administered orally
Interventions
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Orforglipron
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of stress urinary incontinence
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Exdeo Clinical Research Inc
Abbotsford, , Canada
OCT Research ULC
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
Mito Medical Center
Higashiibaraki, , Japan
Nihon University Itabashi Hospital
Itabashiku, , Japan
Kokura Memorial Hospital
Kitakyushu, , Japan
Tokyo Saiseikai Central Hospital
Minatoku, , Japan
Koujunkai Daido Clinic
Nagoya, , Japan
Women's Clinic LUNA NEXT STAGE
Naka-ku, Yokohama-Shi, , Japan
Nakazawa Nephrology and Urology Clinic
Nonoichi, , Japan
Miyabi Urogyne Clinic
Okayama, , 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
Centro de Oncología de Precisión - Mexico City
Mexico City, , Mexico
RM Pharma Specialists - Unidad Especializada en Datos
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
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Related Links
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A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight (RESTRAIN-SUI)
Other Identifiers
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2025-522514-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
J2A-MC-GZPS
Identifier Type: OTHER
Identifier Source: secondary_id
J2A-MC-GZS1
Identifier Type: OTHER
Identifier Source: secondary_id
J2A-MC-GZS2
Identifier Type: OTHER
Identifier Source: secondary_id
27672
Identifier Type: -
Identifier Source: org_study_id