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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGQ | Other Identifier | Eli Lilly and Company | |
| 2022-502837-24-00 | Other Identifier | Eli Lilly and Company | |
| U1111-1289-8799 | Other Identifier | UTN Number |
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This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron Dose 1 | Experimental | Participants will receive orforglipron administered orally. |
|
| Orforglipron Dose 2 | Experimental | Participants will receive orforglipron administered orally. |
|
| Orforglipron Dose 3 | Experimental | Participants will receive orforglipron administered orally. |
|
| Placebo | Placebo Comparator | Participants will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change from Baseline in Body Weight | Baseline, Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Waist Circumference | Baseline, Week 72 | |
| Mean Change from Baseline in Hemoglobin A1c (HbA1c) % | Baseline, Week 72 | |
| Mean Change from Baseline in Fasting Glucose |
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Inclusion Criteria:
Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:
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 |
|---|---|---|---|---|---|---|
| Cahaba Research - Pelham | Pelham | Alabama | 35124 | United States | ||
| Novak Clinical Research - Tucson - North La Cholla Boulevard |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41275875 | Derived | Horn DB, Ryan DH, Kis SG, Alves B, Mu Y, Kim SG, Aberle J, Bain SC, Allen S, Sarker E, Wu Q, Stefanski A, Jouravskaya I; ATTAIN-2 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. Lancet. 2026 Dec 20;406(10522):2927-2944. doi: 10.1016/S0140-6736(25)02165-8. Epub 2025 Nov 20. |
| Label | URL |
|---|---|
| A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2) | 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.
Time Frame:
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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| Placebo | Drug | Administered orally |
|
| Baseline, Week 72 |
| Mean Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 72 |
| Mean Change from Baseline in Fasting Triglycerides | Baseline, Week 72 |
| Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol | Baseline, Week 72 |
| Mean Percent Change from Baseline in Fasting Insulin | Baseline, Week 72 |
| Mean Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 72 |
| Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores | Baseline, Week 72 |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Yuma Clinical Trials | Yuma | Arizona | 85364 | United States |
| AMCR Institute | Escondido | California | 92025 | United States |
| Velocity Clinical Research, Huntington Park | Huntington Park | California | 90255 | United States |
| Velocity Clinical Research, Westlake | Los Angeles | California | 90057 | United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| Encore Medical Research | Hollywood | Florida | 33024 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32216 | United States |
| South Florida Clinical Research Institute | Margate | Florida | 33063 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Balanced Life Health Care Solutions/SKYCRNG | Lawrenceville | Georgia | 30046 | United States |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | United States |
| Pacific Diabetes & Endocrine Center | Honolulu | Hawaii | 96813 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| MedStar Good Samaritan Hospital | Baltimore | Maryland | 21239 | United States |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Las Vegas Medical Research | Las Vegas | Nevada | 89128 | United States |
| IMA Clinical Research | Albuquerque | New Mexico | 87109 | United States |
| Albany Medical College, Division of Community Endocrinology | Albany | New York | 12203 | United States |
| Albany Stratton VA Medical Center | Albany | New York | 12208 | United States |
| NYC Research INC | Long Island City | New York | 11106 | United States |
| Accellacare - Raleigh | Raleigh | North Carolina | 27609 | United States |
| Summit Headlands | Portland | Oregon | 97210 | United States |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37909 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Soma Clinical Trials | Denison | Texas | 75020 | United States |
| Epic Medical Research - DeSoto | DeSoto | Texas | 75115 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | United States |
| Diabetes and Glandular Disease Center | San Antonio | Texas | 78229 | United States |
| VIP Trials | San Antonio | Texas | 78230 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Universal Research Group | Tacoma | Washington | 98405 | United States |
| Mautalen Salud e Investigación | Buenos Aires | Buenos Aires F.D. | C1128AAF | Argentina |
| CEMEDIAB | C.a.b.a. | Ciudad Aut | C1205AAO | Argentina |
| Instituto Centenario | CABA | Ciudad Autónoma de Buenos Aire | 1204 | Argentina |
| Instituto de Investigaciones Clinicas Rosario | Rosario | Santa Fe Province | 2000 | Argentina |
| Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica | Rosario | Santa Fe Province | 2000 | Argentina |
| Sanatorio San Martin | Venado Tuerto | Santa Fe Province | 2600 | Argentina |
| Centro de Investigaciones Médicas Tucuman | SAN M. de Tucuman | Tucumán Province | T4000AXL | Argentina |
| CONEXA Investigacion Clinica S.A. | Buenos Aires | 1012 | Argentina |
| Centro Diabetológico Dr. Waitman | Córdoba | 5000 | Argentina |
| Clínica Universitaria Reina Fabiola | Córdoba | X50004FHP | Argentina |
| Centro de Diagnóstico y Rehabilitación (CEDIR) | Santa Fe | 3000 | Argentina |
| Emeritus Research | Botany | New South Wales | 2019 | Australia |
| The AIM Centre / Hunter Diabetes Centre | Merewether | New South Wales | 2291 | Australia |
| Royal Brisbane and Women's Hospital | Brisbane | Queensland | 4029 | Australia |
| Core Research Group | Brisbane | Queensland | 4064 | Australia |
| Logan Hospital | Meadowbrook | Queensland | 4131 | Australia |
| Southern Adelaide Diabetes & Endocrine Services | Oaklands Park | South Australia | 5046 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Emeritus Research | Camberwell | Victoria | 3124 | Australia |
| Austin Health - Repatriation Hospital | Heidelberg West | Victoria | 3081 | Australia |
| Baker IDI Heart and Diabetes Institute - Melbourne | Melbourne | Victoria | 3004 | Australia |
| Advara HeartCare Joondalup | Joondalup | Western Australia | 6027 | Australia |
| Centro de Pesquisa Clinica do Brasil | Brasília | Federal District | 71625-175 | Brazil |
| Cendi - Endocrinologia e Diabetes | Goiânia | Goiás | 74230-035 | Brazil |
| Instituto Lóbus | Volta Redonda | Rio de Janeiro | 27253-003 | Brazil |
| Instituto Méderi de Pesquisa e Saúde | Passo Fundo | Rio Grande do Sul | 99010-120 | Brazil |
| Instituto de Pesquisa clinica de Campinas | Campinas | São Paulo | 13060-080 | Brazil |
| Centro de Pesquisa Clínica de Marília - CPCLIM | Marília | São Paulo | 17504-072 | Brazil |
| Pesquisare Saude | Santo André | São Paulo | 09080-110 | Brazil |
| CEPIC - Centro Paulista de Investigação Clínica | São Paulo | 04266-010 | Brazil |
| The Second People's Hospital of Hefei | Hefei | Anhui | 230011 | China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| Chongqing General Hospital | Chongqing | Chongqing Municipality | 400014 | China |
| ShenZhen People's Hospital | Shenzhen | Guangdong | 518020 | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The First Affiliated Hospital of Henan University of Science &Technology | Luoyang Shi | Henan | 471003 | China |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450014 | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
| Jiangsu Province Official Hospital | Nanjing | Jiangsu | 210008 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| Nantong First People's Hospital | Nantong | Jiangsu | 226001 | China |
| Wuxi People's Hospital | Wuxi | Jiangsu | 214023 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| Dalian Municipal Central Hospital Affiliated of Dalian Medical University | Dalian | Liaoning | 116033 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Medical University Zhu Xianyi Memorial Hospital | Tianjin | Tianjin Municipality | China |
| The First People's Hospital of Yunnan Province | Kunming | Yunnan | 650034 | China |
| Milan Kvapil s.r.o., Diabetologicka ambulance Pribram | Příbram | Central Bohemia | 26201 | Czechia |
| MUDr. Tomas Edelsberger | Krnov | Moravskosl | 79401 | Czechia |
| Diahelp s.r.o | Pardubice V | Pardubice | 530 02 | Czechia |
| Dialine - Interni a diabetologicka ambulance | Pilsen | Plzeň-město | 301 00 | Czechia |
| Diabet2 s.r.o., diabetologicka a interni ambulance | Prague | Praha 1 | 11000 | Czechia |
| Milan Kvapil s.r.o., Diabetologicka ambulance | Prague | Praha 4 | 14900 | Czechia |
| ResTrial s.r.o. | Prague | Praha 8 | 18100 | Czechia |
| MUDr. Sabina Palova | Jílové u Prahy | Praha-západ | 252 42 | Czechia |
| MUDr. Alena Vachova | České Budějovice | South Bohemian Region | 37011 | Czechia |
| Nemocnice Cesky Krumlov | Český Krumlov | 381 01 | Czechia |
| Endokrinologie MUDr. Rehorkova s.r.o. | Hradec Králové | 500 12 | Czechia |
| MUDr. Jitka Zemanová - diabetologie a interna s.r.o. | Pilsen | 326 00 | Czechia |
| CDG Studienambulanz Hartard | München | Bavaria | 80809 | Germany |
| Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf | Wallerfing | Bavaria | 94574 | Germany |
| Ceda-Research | Pohlheim | Hesse | 35415 | Germany |
| Institut für Diabetesforschung GmbH Münster | Münster | Nordrhein- | 48145 | Germany |
| Universitaetsklinikum Koeln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| InnoDiab Forschung Gmbh | Essen | North Rhine-Westphalia | 45136 | Germany |
| Medizentrum Essen Borbeck | Essen | North Rhine-Westphalia | 45355 | Germany |
| AmBeNet GmbH | Leipzig | Saxony | 04107 | Germany |
| Arztpraxis Christine Kosch Pirna | Pirna | Saxony | 01796 | Germany |
| Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels | Hohenmölsen | Saxony-Anhalt | 06679 | Germany |
| SMO.MD GmbH | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| Universität zu Lübeck - Institut für Endokrinologie und Diabetes | Lübeck | Schleswig-Holstein | 23562 | Germany |
| RED-Institut GmbH | Oldenburg in Holstein | Schleswig-Holstein | 23758 | Germany |
| Diabetes Zentrum Dr. Tews | Gelnhausen | 63571 | Germany |
| Diabetes Zentrum Wilhelmsburg | Hamburg | 21109 | Germany |
| Athens Medical Center | Athens | Attikí | 151 25 | Greece |
| Ippokrateio General Hospital of Thessaloniki | Thessaloniki | Kentrikí Makedonía | 54642 | Greece |
| Euromedica General Clinic of Thessaloniki | Thessaloniki | Thessaloníki | 546 45 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | Thessaloníki | 564 29 | Greece |
| Thermi Clinic | Thessaloniki | Thessaloníki | 570 01 | Greece |
| University General Hospital of Larissa | Larissa | Thessalía | 41110 | Greece |
| 424 Military General Training Hospital | Thessaloniki | 564 29 | Greece |
| Medstar Speciality Hospital | Bangalore | Karnataka | 560092 | India |
| Karnataka Institute of Medical Sciences | Hubli | Karnataka | 580021 | India |
| TOTALL Diabetes Hormone Institute | Indore | Madhya Pradesh | 452010 | India |
| Topiwala National Medical College & B. Y. L. Nair Charitable Hospital | Mumbai | Maharashtra | 400008 | India |
| BSES MG Hospital | Mumbai | Maharashtra | 400058 | India |
| All India Institute of Medical Sciences (AIIMS) - Nagpur | Nagpur | Maharashtra | 441108 | India |
| Sahyadri Super Speciality Hospital | Pune | Maharashtra | 411004 | India |
| Arthur Asirvatham Hospital | Madurai | Tamil Nadu | 625020 | India |
| Kumudini Devi Diabetes Research Center | Hyderabad | Telangana | 500082 | India |
| Advanced Clinical Research, LLC | Bayamón | PR | 00959 | Puerto Rico |
| Isis Clinical Research Center | Guaynabo | PR | 00968 | Puerto Rico |
| Yonsei University-Wonju Severance Christian Hospital | Wŏnju | Kang-won-do | 26426 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | Kyǒnggi-do | 13620 | South Korea |
| Yeungnam Univeristy Medical Center | Gyeongsan-si | Kyǒngsangbuk-do | 42415 | South Korea |
| Korea University Anam Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 02841 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 06591 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | Seoul-teukbyeolsi [Seoul] | 134-090 | South Korea |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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