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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGV | Other Identifier | Eli Lilly and Company | |
| 2023-507206-13-00 | Other Identifier | EU Trial Number | |
| U1111-1296-1507 | Other Identifier | UTN Number |
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The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron Dose 1 | Experimental | Participants will receive orforglipron orally. |
|
| Orforglipron Dose 2 | Experimental | Participants will receive orforglipron orally. |
|
| Orforglipron Dose 3 | Experimental | Participants will receive orforglipron orally. |
|
| Dapagliflozin | Active Comparator | Participants will receive dapagliflozin orally. |
|
| 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 40 | |
| Percentage of Participants Who Achieved HbA1c <7.0% (53 millimole/mole(mmol/mol)) | Week 40 | |
| Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance Research Institute - Canoga Park | Canoga Park | California | 91304 | United States | ||
| Ark Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42259339 | Derived | Welch M, Forst T, Jia W, Del Pino PO, Denning M, Wu WS, Li J, Liu R, Eifu M, Chen Y; ACHIEVE-2 Trial Investigators. Orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin (ACHIEVE-2): a multicentre, randomised, non-inferiority, open-label, phase 3 trial. Lancet. 2026 Jul 11;408(10550):125-140. doi: 10.1016/S0140-6736(26)00800-7. Epub 2026 Jun 8. |
| Label | URL |
|---|---|
| A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2) | View source |
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Anonymized individual participant 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 and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Dapagliflozin | Drug | Administered orally |
|
| Week 40 |
| Percentage Change from Baseline in Body Weight | Baseline, Week 40 |
| Change from Baseline in Body Weight | Baseline, Week 40 |
| Percentage Change from Baseline in Non-High-Density Lipoprotein (non-HDL)-Cholesterol | Baseline, Week 40 |
| Percentage Change from Baseline in Triglycerides | Baseline, Week 40 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 40 |
| Change from Baseline in Fasting Serum Glucose | Baseline, Week 40 |
| Percentage of Participants Who Achieved Weight Loss of ≥5% from Baseline | Baseline to Week 40 |
| Percentage of Participants Who Achieved Weight Loss of ≥10% from baseline | Baseline to Week 40 |
| Percentage of Participants Who Achieved Weight Loss of ≥15% from baseline | Baseline to Week 40 |
| Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 40 |
| Percentage Change from Baseline in Total Cholesterol | Baseline, Week 40 |
| Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores | Baseline, Week 40 |
| Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Change (DTSQc) Scores | Baseline, Week 40 |
| Long Beach |
| California |
| 90815 |
| United States |
| Collaborative Neuroscience Research, LLC | Los Alamitos | California | 90720 | United States |
| Wolverine Clinical Trials | Santa Ana | California | 92706 | United States |
| CMR of Greater New Haven, LLC | Hamden | Connecticut | 06517 | United States |
| Institute of Endocrinology Diabetes, Health & Hormone | Stockbridge | Georgia | 30281 | United States |
| Elite Clinical Trials | Rexburg | Idaho | 83440 | United States |
| Accellacare - DuPage | Lombard | Illinois | 60148 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| St. Vincent Healthcare | Billings | Montana | 59101 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Accellacare - Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Alliance for Multispecialty Research, LLC | Norman | Oklahoma | 73069 | United States |
| Essential Medical Research | Tulsa | Oklahoma | 74137 | United States |
| Accellacare - Mt Pleasant | Mt. Pleasant | South Carolina | 29464 | United States |
| Accellacare, US Inc., d/b/a Accellacare of Knoxville | Jefferson City | Tennessee | 37760 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Juno Research | Houston | Texas | 77040 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| The Second People's Hospital of Hefei | Hefei | Anhui | 230011 | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan | 473007 | China |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450014 | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212000 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| CRS Clinical Research Services Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz | Lingen | Lower Saxony | 49808 | Germany |
| Diabetes- und Stoffwechselpraxis Bochum | Bochum | North Rhine-Westphalia | 44869 | Germany |
| Zentrum fur klinische Forschung - Köln | Cologne | North Rhine-Westphalia | 51069 | Germany |
| InnoDiab Forschung Gmbh | Essen | North Rhine-Westphalia | 45136 | Germany |
| Medizentrum Essen Borbeck | Essen | North Rhine-Westphalia | 45355 | Germany |
| Institut für Diabetesforschung GmbH Münster | Münster | North Rhine-Westphalia | 48145 | Germany |
| Praxis Dr. Veronika Wenzl-Bauer | Rehlingen | Saarland | 66780 | Germany |
| Zentrum für klinische Studien | Saint Ingbert | Saarland | 66386 | Germany |
| RED-Institut GmbH | Oldenburg in Holstein | Schleswig-Holstein | 23758 | Germany |
| Diabetes Zentrum Wilhelmsburg | Hamburg | 21109 | Germany |
| Grupo Ollin Care | Pachuca | Hidalgo | 42000 | Mexico |
| Instituto Jalisciense de Investigacion en Diabetes y Obesidad | Guadalajara | Jalisco | 44600 | Mexico |
| Cryptex Investigación Clínica S.A. de C.V. | Cuauhtémoc, Ciudad de México | Mexico City | 06100 | Mexico |
| ProcliniQ Investigación Clínica SA de CV | Mexico City | Mexico City | 14050 | Mexico |
| Instituto de Diabetes, Obesidad y Nutricion | Cuernavaca | Morelos | 62250 | Mexico |
| Cardiolink Clin Trials | Monterrey | Nuevo León | 64060 | Mexico |
| Clínica García Flores SC | Monterrey | Nuevo León | 64610 | Mexico |
| Servicios Integrales Nova de Monterrey S.A. de C.V. | San Nicolás de los Garza | Nuevo León | 66450 | Mexico |
| Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. | Culiacán | Sinaloa | 80230 | Mexico |
| Consultorio de Medicina Especilizada del Sector Privado | Xalapa | Veracruz | 91193 | Mexico |
| Hospital Angeles Xalapa | Xalapa | Veracruz | 91193 | Mexico |
| Fundación Cardiovascular de Aguascalientes A.C. | Aguascalientes | 20230 | Mexico |
| Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia | Durango | 34000 | Mexico |
| NZOZ Centrum Medyczne KERmed | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-231 | Poland |
| Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET | Krakow | Lesser Poland Voivodeship | 31-261 | Poland |
| Centrum Badań Klinicznych Piotr Napora lekarze sp.p. | Wroclaw | Lower Silesian Voivodeship | 50-162 | Poland |
| Clinical Best Solutions | Lublin | Lublin Voivodeship | 20-011 | Poland |
| CenterMed Lublin NZOZ | Lublin | Lublin Voivodeship | 20-044 | Poland |
| Ekamed | Lublin | Lublin Voivodeship | 20-718 | Poland |
| Centrum Medyczne "Diabetika" | Radom | Masovian Voivodeship | 26-600 | Poland |
| Zdrowie Osteo-Medic | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| Specderm Poznanska | Bialystok | Podlaskie Voivodeship | 15-375 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 SUM | Zabrze | Silesian Voivodeship | 41-800 | Poland |
| Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Łódź Voivodeship | 90-338 | Poland |
| Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung Niao Sung Dist | Kaohsiung | 83301 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| Fu Jen Catholic University Hospital | New Taipei City | 24352 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| 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 |
| C529054 | dapagliflozin |
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