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| ID | Type | Description | Link |
|---|---|---|---|
| J2S-MC-GZMT | Other Identifier | Eli Lilly and Company | |
| 2025-524974-41-00 | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.
The study will last approximately 35 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3537031 | Experimental | LY3537031 administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Placebo administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3537031 | Drug | Administered SC. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks | Week 9 to 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a Weekly Abdominal Pain Response for at Least 50% of Weeks | Week 9 to 16 | |
| Percentage of Participants with a Weekly Complete Spontaneous Bowel Movement (CSBM) for at Least 50% of Weeks | Week 9 to 16 |
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Inclusion Criteria:
Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7
Based on the daily eDiary collection during the screening period:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Del Sol Research Management - Mesa | Recruiting | Mesa | Arizona | 85206 | United States |
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.
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.
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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| Placebo | Drug | Administered SC. |
|
| Smart Cures Clinical Research | Recruiting | Anaheim | California | 92806 | United States |
|
| Om Research LLC | Recruiting | Lancaster | California | 93534 | United States |
|
| United Medical Doctors - Los Alamitos | Recruiting | Los Alamitos | California | 90720 | United States |
|
| Encore Medical Research | Recruiting | Hollywood | Florida | 33024 | United States |
|
| Springfield Clinic - First | Recruiting | Springfield | Illinois | 62702 | United States |
|
| Gastroenterology Health Partners | Recruiting | New Albany | Indiana | 47150 | United States |
|
| Gastroenterology Health Partners | Recruiting | Louisville | Kentucky | 40218 | United States |
|
| New York Gastroenterology Associates | Recruiting | New York | New York | 10075 | United States |
|
| Ohio Gastroenterology | Recruiting | Columbus | Ohio | 43202 | United States |
|
| University Gastroenterology | Recruiting | Providence | Rhode Island | 02905 | United States |
|
| Biopharma Informatic, LLC | Recruiting | McAllen | Texas | 78503 | United States |
|
| Southern Star Research Institute | Recruiting | San Antonio | Texas | 78229 | United States |
|
| GI Alliance-Webster | Recruiting | Webster | Texas | 77598 | United States |
|
| Sint Vincentius Ziekenhuis | Not yet recruiting | Antwerp | 2018 | Belgium |
|
| AZ Sint-Lucas | Not yet recruiting | Bruges | 8310 | Belgium |
|
| UZ Brussel | Not yet recruiting | Brussels | 1090 | Belgium |
|
| Antwerp University Hospital | Not yet recruiting | Edegem | 2650 | Belgium |
|
| AZ Maria Middelares | Not yet recruiting | Ghent | 9000 | Belgium |
|
| AZ Sint-Lucas | Not yet recruiting | Ghent | 9000 | Belgium |
|
| UZ Gent | Not yet recruiting | Ghent | 9000 | Belgium |
|
| UZ Leuven | Not yet recruiting | Leuven | 3000 | Belgium |
|
| Clinical Chc Montlégia | Not yet recruiting | Liège | 4000 | Belgium |
|
| AZ Delta vzw | Not yet recruiting | Roeselare | 8800 | Belgium |
|
| Bluewater Clinical Research Group Inc. | Recruiting | Sarnia | N7T 4X3 | Canada |
|
| Scarborough Center for Inflammatory Bowel Disease | Recruiting | Scarborough | M1B 3V4 | Canada |
|
| ClinSurge Research - LMC Scarborough / Malvern Medical Centre | Recruiting | Scarborough | M1R 0B1 | Canada |
|
| Stouffville Medical Research Institute Inc. | Recruiting | Stouffville | L4A 1H2 | Canada |
|
| Canadian Phase Onward | Recruiting | Toronto | M3J 0K2 | Canada |
|
| Binzhou Medical University Hospital | Not yet recruiting | Binzhou | 256603 | China |
|
| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | 610072 | China |
|
| The First Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | 510080 | China |
|
| Zhejiang Hospital of Traditioal Chinese Medicine | Not yet recruiting | Hangzhou | 310006 | China |
|
| The Second Affiliated Hospital of University of South China | Recruiting | Hengyang | 421200 | China |
|
| Huizhou Central People's Hospital | Not yet recruiting | Huizhou | 516001 | China |
|
| Huzhou Central Hospital | Not yet recruiting | Huzhou | 313000 | China |
|
| Meihekou Central Hospital | Not yet recruiting | Meihekou | 135000 | China |
|
| Quzhou People's Hospital | Not yet recruiting | Quzhou | 324000 | China |
|
| Taian City Central Hospital | Not yet recruiting | Taian | 271000 | China |
|
| Xianning Central Hospital | Not yet recruiting | Xianning | 437100 | China |
|
| Yichun People's Hospital | Recruiting | Yichun | 336000 | China |
|
| Tokyo-Eki Center-building Clinic | Recruiting | Chūōku | 103-0027 | Japan |
|
| Tokai University Hospital | Recruiting | Isehara | 259-1193 | Japan |
|
| Aono Clinic | Recruiting | Kobe | 657-0841 | Japan |
|
| Sapporo Odori Endoscope Clinic | Recruiting | Sapporo | 060-0042 | Japan |
|
| Nishi-Shinjuku Kisaragi Clinic | Recruiting | Shinjuku-Ku | 160-0023 | Japan |
|
| Scientia Investigacion Clinica Tj | Not yet recruiting | Ciudad de Tijuana | 22105 | Mexico |
|
| Centro de Investigación y Gastroenterología - S.C. | Not yet recruiting | Mexico City | 03330 | Mexico |
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| Centro de Investigación Clinica Chapultepec | Not yet recruiting | Mexico City | 04100 | Mexico |
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| Hospital Juarez de Mexico | Not yet recruiting | Mexico City | 07760 | Mexico |
|
| Kohler & Milstein Research S.A. De C.V. | Not yet recruiting | Mérida | 97070 | Mexico |
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| CIMAB SA de CV | Not yet recruiting | Torreón | 27000 | Mexico |
|
| FAICIC S. de R.L. de C.V. | Not yet recruiting | Veracruz | 91900 | Mexico |
|
| Núcleo de Investigación Médica Sur de Guadalajara | Not yet recruiting | Zapopan | 45070 | Mexico |
|
| Hospital Universitari Vall d'Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
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| EAP Osona Sud - Alt Congost S.L.P | Not yet recruiting | Centelles | 08540 | Spain |
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| Hospital Universitario Virgen Nieves | Not yet recruiting | Granada | 18014 | Spain |
|
| Hospital Clinico San Carlos | Not yet recruiting | Madrid | 28040 | Spain |
|
| Hospital Universitario Puerta de Hierro Majadahonda | Not yet recruiting | Madrid | 28222 | Spain |
|
| Hospital Costa del Sol | Not yet recruiting | Marbella | 29603 | Spain |
|
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca | Not yet recruiting | Salamanca | 37007 | Spain |
|
| Clínica Gaias - Santiago | Not yet recruiting | Santiago de Compostela | 15702 | Spain |
|
| Cheadle Community Hospital | Not yet recruiting | Cheadle | ST10 1NS | United Kingdom |
|
| HMC Health Group - Meadows Centre for Health | Recruiting | Hounslow | TW4 7NR | United Kingdom |
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| EMS Healthcare | Not yet recruiting | Macclesfield | SK10 4TF | United Kingdom |
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| Royal Victoria Infirmary | Not yet recruiting | Newcastle upon Tyne | NE1 4LP | United Kingdom |
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| Newquay Health Centre | Recruiting | Newquay | TR7 1RU | United Kingdom |
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| Woodstock Bower Surgery | Recruiting | Rotherham | S61 1AH | United Kingdom |
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| Brockwood Medical Practice | Recruiting | Surrey | RH3 7NJ | United Kingdom |
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| King's Mill Hospital | Recruiting | Sutton in Ashfield | NG17 4JL | United Kingdom |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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