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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGY | Other Identifier | Eli Lilly and Company | |
| 2025-524811-35-00 | EU Trial (CTIS) Number |
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This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them.
Participation in the study will last about 61 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron | Experimental | Participants will receive orforglipron orally |
|
| Dulaglutide | Active Comparator | Participants will receive dulaglutide subcutaneously (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in HbA1c | Baseline, Week 52 | |
| Percentage of Participants with HbA1c ≤6.5% | Week 40 | |
| Percent Change from Baseline in Body Mass Index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 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 |
|---|---|---|---|---|---|---|
| Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology | Sacramento | California | 95821 | 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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| Dulaglutide | Drug | Administered SC |
|
|
| Baseline, Week 40 |
| Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL | Baseline, during 2 weeks prior to Week 40 |
| Percent Change from Baseline in Body Weight | Baseline, Week 40 |
| Change from Baseline in Blood Pressure | Baseline, Week 40 |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 40 |
| Change from Baseline in Waist Circumference | Baseline, Week 40 |
| Change from Baseline in Tanner Staging | Baseline, Week 52 |
| Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B) | Baseline, Week 40 |
| Change from Baseline in the EQ-5D-Y-5L | Baseline, Week 40 |
| Number of Participants by Acceptability Response Category | Baseline, Week 52 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron | Predose through Week 30 |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
|
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | United States |
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| Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP) | Atlanta | Georgia | 30329 | United States |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | United States |
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| Medical Research Partners | Ammon | Idaho | 83406 | United States |
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| Cotton O'Neil Diabetes & Endocrinology | Topeka | Kansas | 66606 | United States |
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| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Advantage Clinical Trials | The Bronx | New York | 10467 | United States |
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| Central States Research | Tulsa | Oklahoma | 74136 | United States |
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| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | United States |
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| Vanderbilt Health One Hundred Oaks | Nashville | Tennessee | 37204 | United States |
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| Gadolin Research | Beaumont | Texas | 77702 | United States |
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| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
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| Proactive Clinical Research LLC | Edinburg | Texas | 78539 | United States |
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| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
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| Victoria Clinical Research Group | Victoria | Texas | 77901 | United States |
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| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
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| UZ Gent | Ghent | 9000 | Belgium |
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| UZ Leuven | Leuven | 3000 | Belgium |
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| Instituto de Pesquisa clinica de Campinas | Campinas | 13060-080 | Brazil |
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| Centro de Pesquisa Sao Lucas | Campinas | 13060-803 | Brazil |
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| Cendi - Endocrinologia e Diabetes | Goiânia | 74230-035 | Brazil |
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| Instituto Méderi de Pesquisa e Saúde | Passo Fundo | 99010-120 | Brazil |
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| Instituto da Crianca com Diabetes | Porto Alegre | 91350-250 | Brazil |
|
| Instituto de Pesquisa Clinica | São Paulo | 01223-001 | Brazil |
|
| IBTED - Tecnologia e Educação em Diabetes | São Paulo | 04038-032 | Brazil |
|
| Avron Hospitals | Ahmedabad | 380013 | India |
|
| Gujarat Endocrin Pvt Ltd | Ahmedabad | 380052 | India |
|
| Jawaharlal Nehru Medical College | Aligarh | 202002 | India |
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| All India Institute of Medical Sciences | Bhubaneswar | 751019 | India |
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| Endolife Speciality Hospitals | Guntur | 522001 | India |
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| King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College | Mumbai | 400012 | India |
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| Harmony Health Hub | Nashik | 422002 | India |
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| All India Institute of Medical Sciences | New Delhi | 110029 | India |
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| Ospedale Pediatrico Salesi | Ancona | 60123 | Italy |
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| Azienda Ospedaliera Universitaria Meyer IRCCS | Florence | 50139 | Italy |
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| IRCCS Istituto Giannina Gaslini | Genova | 16147 | Italy |
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| Azienda Ospedaliera Universitaria Di Messina G. Martino | Messina | 98125 | Italy |
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| Ospedale San Raffaele | Milan | 20132 | Italy |
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| University of Naples Federico II | Naples | 80131 | Italy |
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| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento | Verona | 37126 | Italy |
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| Nihon University Hospital | Chiyoda-ku | 101-8309 | Japan |
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| Fukuoka Children's Hospital | Fukuoka | 813-0017 | Japan |
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| Saitama Medical University Hospital | Iruma | 350-0495 | Japan |
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| Shiga General Hospital | Moriyama | 524-8524 | Japan |
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| Niigata University Medical & Dental Hospital | Niigata | 951-8520 | Japan |
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| Osaka City General Hospital | Osaka | 534-0021 | Japan |
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| Saitama City Hospital | Saitama | 336-8522 | Japan |
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| Sendai City Hospital - Asutonagamachi | Sendai | 982-8502 | Japan |
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| Shizuoka Children's Hospital | Shizuoka | 420-0953 | Japan |
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| Urakami Pediatric Endocrinology and Diabetes Clinic | Tokyo | 101-0062 | Japan |
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| Juntendo University Urayasu Hospital | Urayasu | 279-0021 | Japan |
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| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. | Ciudad Madero | 89440 | Mexico |
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| Centro de Investigacion Medica de Occidente, S.C. | Guadalajara | 44260 | Mexico |
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| UBAM Unidad Biomedica Avanzada Monterrey | Monterrey | 64460 | Mexico |
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| Clínica García Flores SC | Monterrey | 64610 | Mexico |
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| Centro de investigación y control metabólico | Monterrey | 66465 | Mexico |
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| Soon Chun Hyang University Bucheon Hospital | Bucheon-si | 14584 | South Korea |
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| Kyungpook National University Chilgok Hospital | Deagu | 41404 | South Korea |
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| Chungnam national university hospital | Junggu | 35015 | South Korea |
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| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
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| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
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| H.R.U Málaga - Hospital General | Málaga | 29011 | Spain |
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| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
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| China Medical University Hospital | Taichung | 404332 | Taiwan |
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| Chang Gung Medical Foundation-Linkou Branch | Taoyuan | 333 | Taiwan |
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| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
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| Alder Hey Children's Hospital | Liverpool | L14 5AB | United Kingdom |
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| Royal London Hospital | London | E1 1BB | United Kingdom |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
| C555680 | dulaglutide |
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