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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGU | Other Identifier | Eli Lilly and Company | |
| U1111-1290-6014 | Other Identifier | UTN Number |
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The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 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. |
|
| Semaglutide Dose 1 | Active Comparator | Participants will receive semaglutide orally. |
|
| Semaglutide Dose 2 | Active Comparator | Participants will receive semaglutide 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 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in HbA1c | Baseline, Week 52 | |
| Percentage of Participants Who Achieved HbA1c <7.0% 53 millimole/mole (mmol/mol) | Week 52 | |
| 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 |
|---|---|---|---|---|---|---|
| Absolute Clinical Research | Phoenix | Arizona | 85051 | United States | ||
| San Fernando Valley Health Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41765029 | Derived | Rosenstock J, Yabe D, Cox D, Li J, Denning M, Wu WS, Liu R, Zhao Y; ACHIEVE-3 Investigators. Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial. Lancet. 2026 Mar 21;407(10534):1147-1160. doi: 10.1016/S0140-6736(26)00202-3. Epub 2026 Feb 26. |
| Label | URL |
|---|---|
| A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin (ACHIEVE-3) | View source |
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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 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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| Semaglutide | Drug | Administered orally |
|
| Week 52 |
| Percentage Change from Baseline in Body Weight | Baseline, Week 52 |
| Change from Baseline in Body Weight | Baseline, Week 52 |
| Percentage of Participants Who Achieved HbA1c <5.7% (39 mmol/mol) | Week 52 |
| Change from Baseline in Fasting Serum Glucose | Baseline, Week 52 |
| Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose (SMBG) | Baseline, Week 52 |
| Percentage of Participants Who Achieved Weight Loss of ≥5% | Week 52 |
| Percentage of Participants Who Achieved Weight Loss of ≥10% | Week 52 |
| Percentage of Participants Who Achieved Weight Loss of ≥15% | Week 52 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 52 |
| Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 52 |
| Percentage Change from Baseline in Total Cholesterol | Baseline, Week 52 |
| Percentage Change from Baseline in High Density Lipoprotein (HDL)-Cholesterol | Baseline, Week 52 |
| Percentage Change from Baseline in Low Density Lipoprotein (LDL)-Cholesterol | Baseline, Week 52 |
| Percentage Change from Baseline in Very Low Density Lipoprotein (VLDL)-Cholesterol | Baseline, Week 52 |
| Percentage Change from Baseline in Non-HDL-Cholesterol | Baseline, Week 52 |
| Percentage Change from Baseline in Triglycerides | Baseline, Week 52 |
| Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores | Baseline, Week 52 |
| Canoga Park |
| California |
| 91304 |
| United States |
| Neighborhood Healthcare Institute of Health | Escondido | California | 92025 | United States |
| Velocity Clinical Research, Gardena | Gardena | California | 90247 | United States |
| Biopharma Informatic, LLC | Los Angeles | California | 90035 | United States |
| Velocity Clinical Research, Westlake | Los Angeles | California | 90057 | United States |
| Infinity Clinical Research - Norco | Norco | California | 92860 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Norcal Endocrinology & Internal Medicine | San Ramon | California | 94583 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| New West Physicians Clinical Research | Golden | Colorado | 80401 | United States |
| Connecticut Clinical Research - Cromwell | Cromwell | Connecticut | 06416 | United States |
| Clinical Research of West Florida, Inc. (Clearwater) | Clearwater | Florida | 33765 | United States |
| South Florida Clinical Research Institute | Margate | Florida | 33063 | United States |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | United States |
| West Orange Endocrinology | Ocoee | Florida | 34761 | United States |
| Latin Clinical Trial Center Florida | Tamarac | Florida | 33321 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33606 | United States |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | United States |
| Balanced Life Health Care Solutions/SKYCRNG | Lawrenceville | Georgia | 30046 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | United States |
| Northwest Clinical Trials | Boise | Idaho | 83704 | United States |
| Family First Medical Center | Idaho Falls | Idaho | 83404 | United States |
| American Health Network of Indiana, LLC - Greenfield | Greenfield | Indiana | 46140 | United States |
| Velocity Clinical Research, Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Cotton O'Neil Diabetes & Endocrinology | Topeka | Kansas | 66606 | United States |
| Tekton Research, Inc | Wichita | Kansas | 67218 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Revival Research Institute, LLC | Dearborn | Michigan | 48126 | United States |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | United States |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | United States |
| Logan Health Research | Kalispell | Montana | 59901 | United States |
| Wr-Crcn, Llc | Las Vegas | Nevada | 89106 | United States |
| Premier Research | Trenton | New Jersey | 08611 | United States |
| Albany Medical College, Division of Community Endocrinology | Albany | New York | 12203 | United States |
| Ellipsis Research Group - Brooklyn - 7th Street | Brooklyn | New York | 11215 | United States |
| Great Lakes Medical Research, LLC | Westfield | New York | 14787 | United States |
| PharmQuest Life Sciences, LLC | Greensboro | North Carolina | 27408 | United States |
| Lucas Research, Inc | Morehead City | North Carolina | 28557 | United States |
| Accellacare - Piedmont | Statesville | North Carolina | 28625 | United States |
| Wake Forest University Baptist Medical Center (WFUBMC) | Winston-Salem | North Carolina | 27104 | United States |
| Aventiv Research Inc | Columbus | Ohio | 43213 | United States |
| Tekton Research, Inc | Moore | Oklahoma | 73160 | United States |
| Alliance for Multispecialty Research, LLC | Norman | Oklahoma | 73069 | United States |
| The Corvallis Clinic, P.C. | Corvallis | Oregon | 97330 | United States |
| Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania | 15009 | United States |
| Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) | Pittsburgh | Pennsylvania | 15236 | United States |
| The Research Center of The Upstate | Greenville | South Carolina | 29607 | United States |
| New Phase Research and Development | Knoxville | Tennessee | 37909 | United States |
| Clinical Neuroscience Solutions Inc. | Memphis | Tennessee | 38119 | United States |
| Velocity Clinical Research, Austin | Austin | Texas | 78759 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Diabetes and Thyroid Center of Ft. Worth | Fort Worth | Texas | 76132 | United States |
| Juno Research | Houston | Texas | 77040 | United States |
| Endocrine Ips, Pllc | Houston | Texas | 77079 | United States |
| Clear Brook Medical Associates | Houston | Texas | 77089 | United States |
| Southern Endocrinology Associates | Mesquite | Texas | 75149 | United States |
| Texas Valley Clinical Research | Weslaco | Texas | 78596 | United States |
| Synexus Clinical Research US, Inc. | Salt Lake City | Utah | 84106 | United States |
| Eastside Research Associates | Redmond | Washington | 98052 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| Centro de Investigaciones Metabólicas (CINME) | Ciudad Autónoma de Buenos Aires | Buenos Aires | 1056 | Argentina |
| CIMeL | Lanus | Buenos Aires | B1824KAJ | Argentina |
| Centro de Investigaciones Médicas Mar del Plata | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Policlinica Red OMIP | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Consultorio de Investigación Clínica EMO SRL | Buenos Aires | Buenos Aires F.D. | 1405 | Argentina |
| CIPREC | Buenos Aires | Buenos Aires F.D. | C1061AAS | Argentina |
| Centro Médico Viamonte | Buenos Aires | Buenos Aires F.D. | C1120AAC | Argentina |
| Instituto Centenario | CABA | Buenos Aires F.D. | 1204 | Argentina |
| Centro de Salud e Investigaciones Médicas | Santa Rosa | La Pampa Province | 6300 | Argentina |
| INECO Neurociencias Oroño | Rosario | Santa Fe Province | 2000 | Argentina |
| Instituto de Especialidades de la Salud Rosario | Rosario | Santa Fe Province | 2000 | Argentina |
| Instituto Médico Catamarca IMEC | Rosario | Santa Fe Province | 2000 | Argentina |
| Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica | Rosario | Santa Fe Province | 2000 | Argentina |
| Fundacion Estudios Clinicos | Rosario | Santa Fe Province | S2000DEJ | Argentina |
| Instituto de Investigaciones Clínicas Córdoba | Córdoba | 5000 | Argentina |
| Instituto Médico DAMIC | Córdoba | 5003DCE | Argentina |
| Sanatorio Norte | Santiago del Estero | 4200 | Argentina |
| Beijing Pinggu District Hospital | Beijing | Beijing Municipality | 101200 | China |
| Chongqing General Hospital | Chongqing | Chongqing Municipality | 400014 | China |
| Shunde Hospital of Southern Medical Univesity | Foshan | Guangdong | 528399 | China |
| Huizhou Municipal Central Hospital | Huizhou | Guangdong | 516001 | China |
| The Fourth Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The First Affiliated Hospital of Henan University of Science &Technology | Luoyang Shi | Henan | 471003 | China |
| Nanyang First People's Hospital | Nanyang | Henan | 473014 | 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 |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212000 | China |
| Jiangxi Pingxiang People's Hospital | Pingxiang | Jiangxi | 337055 | China |
| Dalian Municipal Central Hospital Affiliated of Dalian Medical University | Dalian | Liaoning | 116033 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| Pudong New Area People's Hospital Shanghai | Shanghai | Shanghai Municipality | 201200 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | 310013 | China |
| Huzhou Central Hospital | Huzhou | Zhejiang | 313000 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| Mikannohana Clinic, Diabetes, Endocrinology and Metabolism | Matsuyama | Ehime | 116099 | Japan |
| Manda Memorial Hospital | Sapporo | Hokkaido | 060-0062 | Japan |
| Nakamoto Internal Medicine Clinic | Mito | Ibaraki | 310-0826 | Japan |
| Nakakinen clinic | Naka | Ibaraki | 311-0113 | Japan |
| Ohishi Internal Medicine Clinic | Tsuchiura | Ibaraki | 300-0835 | Japan |
| Takai Internal Medicine Clinic | Kamakura-shi | Kanagawa | 247-0056 | Japan |
| Shiraiwa Medical Clinic | Kashihara | Osaka | 582-0005 | Japan |
| Medical Corporation Sato Medical clinic | Ootaku | Tokyo | 143-0015 | Japan |
| Gifu University Hospital | Gifu | 501-1112 | Japan |
| Centro de Investigacion Medica Integral | Guadalajara | Jalisco | 44160 | Mexico |
| Instituto Jalisciense de Investigacion en Diabetes y Obesidad | Guadalajara | Jalisco | 44600 | Mexico |
| CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C | Guadalajara | Jalisco | 44670 | Mexico |
| Private Practice - Dr. Arechavaleta Granell Maria del Rosario | Guadalajara | Jalisco | 44670 | Mexico |
| Virgen Cardiovascular Research SC | Guadalajara | Jalisco | 44670 | Mexico |
| Centro de Investigacion Medica de Occidente, S.C. | Zapopan | Jalisco | 44260 | Mexico |
| Caimed Investigacion En Salud S.A. de C.V. | Mexico City | Mexico City | 06760 | Mexico |
| Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares | Mexico City | Mexico City | 11650 | Mexico |
| Cardiolink Clin Trials | Monterrey | Nuevo León | 64060 | Mexico |
| Unidad biomedica avanzada monterrey | Monterrey | Nuevo León | 64460 | Mexico |
| Clínica García Flores SC | Monterrey | Nuevo León | 64610 | Mexico |
| Eukarya PharmaSite | Monterrey | Nuevo León | 64718 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 66460 | Mexico |
| Centro de investigación y control metabólico | San Nicolás de los Garza | Nuevo León | 66465 | Mexico |
| Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. | Culiacán | Sinaloa | 80230 | Mexico |
| Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia | Durango | 34000 | Mexico |
| Isis Clinical Research Center | Guaynabo | PR | 00968 | Puerto Rico |
| Mgcendo Llc | San Juan | PR | 00921 | Puerto Rico |
| Research and Cardiovascular Corp. | Ponce | 00717 | Puerto Rico |
| Latin Clinical Trial Center | San Juan | 00909 | Puerto Rico |
| 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 |
| C000591245 | semaglutide |
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