Actively Recruiting
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
Led by Eli Lilly and Company · Updated on 2026-06-04
1000
Participants Needed
137
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how well and safely orforglipron works in adult women with stress urinary incontinence (SUI) who are overweight or have obesity. SUI causes urine leakage during activities like coughing or exercising. This research is a phase 3 trial sponsored by Eli Lilly and Company and will last about 58 weeks from screening to safety follow-up. Participants will be randomly assigned to take orforglipron tablets or a placebo orally once daily. The trial includes two independent studies under one protocol, each comparing orforglipron with placebo. The goal is to see how orforglipron affects urinary incontinence and related health measures over one year. During the study, participants will have regular assessments to track changes in incontinence episode frequency, body weight, quality of life related to urinary incontinence, use of continence pads, patient impressions of their condition, cholesterol levels, and waist circumference. Safety will also be monitored throughout the 58-week participation period.
CONDITIONS
Brief Title
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants
- Age 18 years or older
- Body mass index (BMI) of 27 kilograms per square meter or higher at screening
- Diagnosed with stress urinary incontinence
You will not qualify if you...
- Previous urinary incontinence surgery
- Recent treatment with onabotulinumtoxin A (Botox) bladder injections
- Currently taking medications for urinary incontinence
- Given birth within one year prior to screening
- Body weight change greater than 11 pounds within 90 days before screening
- Use of anti-obesity medication or alternative weight loss remedies within 180 days prior to screening
- Diagnosis of type 1 diabetes, type 2 diabetes, or any other diabetes
- Cardiovascular health condition within 90 days prior to screening
- Pregnant, intending to become pregnant, breastfeeding, or intending to breastfeed during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive daily oral doses of orforglipron or placebo to treat stress urinary incontinence while managing overweight or obesity.
Visits at baseline and periodically during treatment up to Week 52
Trial Site Locations
Total: 137 locations
1
University of Alabama -The Kirklin Clinic
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
AMR Clinical
Mobile, Alabama, United States, 36608
Actively Recruiting
3
Urologic Surgeons of Arizona
Mesa, Arizona, United States, 85206
Actively Recruiting
4
Matrix Clinical Research
Los Angeles, California, United States, 90057
Actively Recruiting
5
Alarcon Urology Center
Montebello, California, United States, 90640
Actively Recruiting
6
Prestige Medical Group
Tustin, California, United States, 92780
Actively Recruiting
7
Colorado Clinical Research
Lakewood, Colorado, United States, 80228
Actively Recruiting
8
AMR Clinical
Fort Myers, Florida, United States, 33912
Actively Recruiting
9
Altus Research
Lake Worth, Florida, United States, 33461
Actively Recruiting
10
New Age Medical Research Corporation
Miami, Florida, United States, 33186
Actively Recruiting
11
Emerald Coast OBGYN Clinical Research
Panama City, Florida, United States, 32405
Actively Recruiting
12
Teak Research Consults
Lawrenceville, Georgia, United States, 30043
Actively Recruiting
13
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States, 48098
Actively Recruiting
14
OB/GYN Associates of Erie
Erie, Pennsylvania, United States, 16507
Actively Recruiting
15
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
16
Next Level Urgent Care
Houston, Texas, United States, 77057
Actively Recruiting
17
Innovative Medical Research of Texas
Houston, Texas, United States, 77065
Actively Recruiting
18
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States, 23606
Actively Recruiting
19
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Actively Recruiting
20
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
21
Seattle Clinical Research Center
Seattle, Washington, United States, 98104
Actively Recruiting
22
OCT Research ULC
Kelowna, Canada, V1Y 1Z9
Actively Recruiting
23
Kelowna Health and Memory Centre
Kelowna, Canada, V1Y 5A8
Actively Recruiting
24
Alpha Recherche Clinique - Lévis
Lévis, Canada, G6V 0C9
Actively Recruiting
25
The Fe/Male Health Centre
Oakville, Canada, L6H 3P1
Actively Recruiting
26
Alpha Recherche Clinique
Québec, Canada, G2J 0C4
Actively Recruiting
27
ALPHA Recherche Clinique
Québec, Canada, G3K 2P8
Actively Recruiting
28
CaRe Clinic
Red Deer, Canada, T4P 1K4
Actively Recruiting
29
Sunnybrook Research Institute
Toronto, Canada, M4N 3M5
Actively Recruiting
30
Peking University First Hospital
Beijing, China, 100032
Actively Recruiting
31
Peking University People's Hospital
Beijing, China, 100034
Actively Recruiting
32
Xuanwu Hospital Capital Medical University
Beijing, China, 100053
Actively Recruiting
33
Peking University Third Hospital
Beijing, China, 100091
Actively Recruiting
34
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Not Yet Recruiting
35
Chengdu Women and Children Center Hospital
Chengdu, China, 610091
Actively Recruiting
36
2nd Affiliated Hospital Chongqing Medical University
Chongqing, China, 400010
Actively Recruiting
37
Zhujiang Hospital
Guangzhou, China, 510280
Actively Recruiting
38
The First Affiliated Hospital of Jinan University
Guangzhou, China, 510630
Actively Recruiting
39
Zhejiang Provincial People's Hospital
Hangzhou, China, 310014
Actively Recruiting
40
Second Affiliated hospital of Anhui Medical University
Hefei, China, 230000
Actively Recruiting
41
Gansu Provincial Hospital
Lanzhou, China, 730000
Actively Recruiting
42
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, China, 210000
Actively Recruiting
43
Ningbo First Hospital
Ningbo, China, 315010
Actively Recruiting
44
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China, 200011; 200090
Actively Recruiting
45
Peking University Shenzhen Hospital
Shenzhen, China, 518036
Actively Recruiting
46
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
Actively Recruiting
47
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430030
Actively Recruiting
48
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710061
Actively Recruiting
49
The First Affiliated hospital of Xiamen University
Xiamen, China, 361003
Actively Recruiting
50
General Hospital of Ningxia Medical University
Yinchuan, China, 750004
Actively Recruiting
51
Afimed - Urologicka ambulance
Benešov, Czechia, 256 01
Actively Recruiting
52
Gynekologie Šottner
Brno, Czechia, 603 00
Actively Recruiting
53
Centrum Panevniho Dna
Karlovy Vary, Czechia, 360 17
Actively Recruiting
54
Kestr-gyn
Náchod, Czechia, 547 01
Actively Recruiting
55
G-CENTRUM Olomouc
Olomouc, Czechia, 772 00
Actively Recruiting
56
NEUMED gynekologická ambulance
Olomouc, Czechia, 779 00
Actively Recruiting
57
GYNORD plus
Ostrava, Czechia, 709 00
Actively Recruiting
58
Gyncare
Pilsen, Czechia, 301 00
Actively Recruiting
59
Nestátní zdravotnické zařízení GONA
Prague, Czechia, 110 00
Actively Recruiting
60
Devasya Superspeciality Kidney & Multispeciality Hospitals
Ahmedabad, India, 380013
Not Yet Recruiting
61
Apollo Hospitals Ahmedabad
Ahmedabad, India, 382428
Not Yet Recruiting
62
KLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi, India, 590010
Not Yet Recruiting
63
Belagavi Institute of Medical Sciences - Belagavi
Belgavi, India, 590019
Not Yet Recruiting
64
All India Institute of Medical Sciences
Bhubaneswar, India, 751019
Not Yet Recruiting
65
Postgraduate Institute of Medical Education & Research
Chandigarh, India, 160012
Not Yet Recruiting
66
Apollo Hospitals - Chennai
Chennai, India, 600006
Not Yet Recruiting
67
Malla Reddy Narayana Multispeciality Hospital
Hyderabad, India, 500055
Not Yet Recruiting
68
Ketki Nursing Home & Urology Hospital
Nagpur, India, 440012
Not Yet Recruiting
69
Sir Ganga Ram Hospital
New Delhi, India, 110060
Not Yet Recruiting
70
Lifepoint Multispeciality Hospital
Pune, India, 411057
Not Yet Recruiting
71
All India Institute of Medical Sciences
Raipur, India, 492099
Not Yet Recruiting
72
All India Institute of Medical Sciences - Rishikesh
Rishikesh, India, 249203
Not Yet Recruiting
73
Surat Institute of Digestive Sciences Hospitals
Surat, India, 395002
Not Yet Recruiting
74
Banaras Hindu University
Varanasi, India, 221005
Not Yet Recruiting
75
Hasegawa Hospital - Arakawa
Arakawa City, Japan, 116-0014
Actively Recruiting
76
Takasu Nephrology and Urology Clinic
Chiba, Japan, 261-0004
Actively Recruiting
77
Yotsuya Medical Cube
Chiyoda City, Japan, 102-0084
Actively Recruiting
78
St. Luke's International Hospital
Chūōku, Japan, 104-8560
Actively Recruiting
79
Mito Medical Center
Higashiibaraki, Japan, 311-3117
Actively Recruiting
80
Nihon University Itabashi Hospital
Itabashiku, Japan, 173-8610
Actively Recruiting
81
Kokura Memorial Hospital
Kitakyushu, Japan, 802-8555
Actively Recruiting
82
Touyu Clinic
Matsudo, Japan, 270-0034
Actively Recruiting
83
Tokyo Saiseikai Central Hospital
Minatoku, Japan, 108-0073
Actively Recruiting
84
Koujunkai Daido Clinic
Nagoya, Japan, 457-8511
Actively Recruiting
85
Women's Clinic LUNA NEXT STAGE
Naka-ku, Yokohama-Shi, Japan, 231-0861
Actively Recruiting
86
Chiba Saiseikai Narashino hospital
Narashino, Japan, 275-8580
Actively Recruiting
87
Nakazawa Nephrology and Urology Clinic
Nonoichi, Japan, 921-8824
Actively Recruiting
88
Miyabi Urogyne Clinic
Okayama, Japan, 700-0822
Actively Recruiting
89
Nakatsu Hospital
Osaka, Japan, 530-0012
Actively Recruiting
90
Yukigaya Urology Clinic
Ōta-ku, Japan, 145-0065
Actively Recruiting
91
Kashiwazaki Obstetrics and Gynecology Clinic
Saitama-shi, Japan, 330-0855
Actively Recruiting
92
Izumi Chuo Hospital
Sendai, Japan, 981-3121
Actively Recruiting
93
Toride Urology Clinic
Toride, Japan, 302-0021
Actively Recruiting
94
Tsukuba Urocare Clinic
Tsukuba, Japan, 305-0821
Actively Recruiting
95
Medical Center Metas
Chihuahua City, Mexico, 31110
Actively Recruiting
96
Scientia Investigacion Clinica S.C.
Chihuahua City, Mexico, 31207
Actively Recruiting
97
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, Mexico, 89440
Actively Recruiting
98
Health Pharma Querétaro
Juriquilla, Mexico, 76230
Actively Recruiting
99
RM Pharma Specialists - Unidad Especializada en Datos
Mexico City, Mexico, 03100
Actively Recruiting
100
Centro de Oncología de Precisión - Mexico City
Mexico City, Mexico, 03330
Not Yet Recruiting
101
Quemex Medical and Research
Mexico City, Mexico, 14308
Actively Recruiting
102
Medical Care and Research SA de CV
Mérida, Mexico, 97070
Actively Recruiting
103
Clinstile, S.A. de C.V.
México, Mexico, 06700
Not Yet Recruiting
104
Jose Gerardo Garza Leal
Monterrey, Mexico, 64060
Not Yet Recruiting
105
Centro de investigación y control metabólico
Monterrey, Mexico, 66465
Actively Recruiting
106
Centro de Investigacion Clinica Chapultepec
Morelia, Mexico, 58260
Not Yet Recruiting
107
Medimanage Research
Tlalpan, Mexico, 14050
Actively Recruiting
108
IN VIVO
Bydgoszcz, Poland, 85-048
Actively Recruiting
109
AIDPORT Sp. z o.o.
Skórzewo, Poland, 60-185
Actively Recruiting
110
Centrum Medyczne Euromedis
Szczecin, Poland, 70-111
Actively Recruiting
111
Medical Concierge Centrum Medyczne
Warsaw, Poland, 02-798
Actively Recruiting
112
Centrum Medyczne Ginemedica
Wroclaw, Poland, 50-414
Actively Recruiting
113
EMC Instytut Medyczny SA
Wroclaw, Poland, 54-239
Actively Recruiting
114
Centrul Medical Unirea
Brasov, Romania, 500091
Actively Recruiting
115
Spitalul Clinic Judetean de Urgenta (Brasov)
Brasov, Romania, 500152
Actively Recruiting
116
Spitalul Clinic de Nefrologie Doctor Carol Davila
Bucharest, Romania, 010731
Actively Recruiting
117
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
Bucharest, Romania, 010825
Not Yet Recruiting
118
Delta Health Care
Bucharest, Romania, 014142
Actively Recruiting
119
Spitalul Clinic Colentina
Bucharest, Romania, 020125
Actively Recruiting
120
Spitalul de Urgenta al Ministerului Administratiei si Internelor "Prof. Dr. Dimitrie Gerota"
Bucharest, Romania, 021373
Actively Recruiting
121
Spitalul Clinic Județean de Urgență Ilfov
Bucharest, Romania, 022105
Actively Recruiting
122
Fundeni Clinical Institute
Bucharest, Romania, 022328
Actively Recruiting
123
Gnosis Evomed S.R.L.
Bucharest, Romania, 030913
Actively Recruiting
124
Spitalul Clinic Profesor Doctor Theodor Burghele
Bucharest, Romania, 050659
Actively Recruiting
125
Spitalul Clinic Județean de Urgență
Craiova, Romania, 200642
Actively Recruiting
126
Spitalul Clinic Judetean De Urgenta Bihor
Oradea, Romania, 410169
Actively Recruiting
127
Clinica Polisano
Sibiu, Romania, 550253
Not Yet Recruiting
128
Polaris Medical SA
Suceagu, Romania, 407062
Actively Recruiting
129
S.C. Materna Care S.R.L.
Timișoara, Romania, 300645
Actively Recruiting
130
Spitalul Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara
Timișoara, Romania, 300723
Actively Recruiting
131
Hallym University Sacred Heart Hospital
Anyang-si, South Korea, 14068
Actively Recruiting
132
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, South Korea, 14647
Actively Recruiting
133
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
134
Chonnam National University Hospital
Gwangju, South Korea, 61469
Actively Recruiting
135
Kyungpook National University Hospital
Junggu, South Korea, 41944
Actively Recruiting
136
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
137
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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