A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Recruiting · NCT07202884 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
OrforglipronPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 11 US states.
- 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
- Devasya Superspeciality Kidney & Multispeciality Hospitals - Ahmedabad, India
- Apollo Hospitals Ahmedabad - Ahmedabad, India
- Hallym University Sacred Heart Hospital - Anyang-si, South Korea
- Hasegawa Hospital - Arakawa - Arakawa City, Japan
- Peking University People's Hospital - Beijing, China
- Xuanwu Hospital Capital Medical University - Beijing, China
- Peking University Third Hospital - Beijing, China
- Peking University First Hospital - Beijing, China
- KLES Dr. Prabhakar Kore Hospital & M.R.C - Belagavi, India
- Belagavi Institute of Medical Sciences - Belagavi - Belgavi, India
- Afimed - Urologicka ambulance - Benešov, Czechia
- All India Institute of Medical Sciences - Bhubaneswar, India
- Centrul Medical Unirea - Brasov, Romania
- Spitalul Clinic Judetean de Urgenta (Brasov) - Brasov, Romania
- Gynekologie Šottner - Brno, Czechia
- Spitalul Clinic de Nefrologie Doctor 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
- The Catholic University of Korea, Bucheon St. Mary's Hospital - Bucheon-si, South Korea
- Pusan National University Hospital - Busan, South Korea
- IN VIVO - Bydgoszcz, Poland
- Postgraduate Institute of Medical Education & Research - Chandigarh, India
- Sichuan Provincial People's Hospital - Chengdu, China
- Chengdu Women and Children Center Hospital - Chengdu, China
- Apollo Hospitals - Chennai - Chennai, India
- Takasu Nephrology and Urology Clinic - Chiba, Japan
- Medical Center Metas - Chihuahua City, Mexico
- Scientia Investigacion Clinica S.C. - Chihuahua City, Mexico
- Yotsuya Medical Cube - Chiyoda City, Japan
- 2nd Affiliated Hospital Chongqing Medical University - Chongqing, China
- St. Luke's International Hospital - Chūōku, Japan
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. - Ciudad Madero, Mexico
- Spitalul Clinic Județean de Urgență - Craiova, Romania
- Zhujiang Hospital - Guangzhou, China
Showing 60 of 136 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →