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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521098-14-00 | EU Trial (CTIS) Number | ||
| J2A-MC-GZPO | Other Identifier | Eli Lilly and Company | |
| J2A-MC-GZP1 | Other Identifier | Eli Lilly and Company | |
| J2A-MC-GZP2 | Other Identifier | Eli Lilly and Company |
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The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron Dose 1 (Study GZP1) | Experimental | Participants will receive orforglipron orally |
|
| Orforglipron Dose 2 (Study GZP1) | Experimental | Participants will receive orforglipron orally |
|
| Orforglipron Dose 3 (Study GZP1) | Experimental | Participants will receive orforglipron orally |
|
| Orforglipron Dose 4 (Study GZP1) | Experimental | Participants will receive orforglipron orally |
|
| Placebo (Study GZP1) | Placebo Comparator | Participants will receive placebo orally |
|
| Orforglipron Dose 1 (Study GZP2) | Experimental | Participants will receive orforglipron orally |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Allocated to Each Study | Baseline to Week 4 |
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There are no specific eligibility criteria for the Master Protocol.
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| 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 |
|---|---|---|---|---|---|---|
| Clinical Research Institute of Arizona (CRI) - Sun City West | Sun City West | Arizona | 85375 | 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 and approval of the indication studied in the US and 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.
Phase 3b
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|
| Orforglipron Dose 2 (Study GZP2) | Experimental | Participants will receive orforglipron orally |
|
| Orforglipron Dose 3 (Study GZP2) | Experimental | Participants will receive orforglipron orally |
|
| Orforglipron Dose 4 (Study GZP2) | Experimental | Participants will receive orforglipron orally |
|
| Placebo (Study GZP2) | Placebo Comparator | Participants will receive placebo orally |
|
| Placebo | Drug | Administered orally |
|
| Novak Clinical Research - Tucson - North La Cholla Boulevard |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Norcal Endocrinology & Internal Medicine | San Ramon | California | 94583 | United States |
| Southern California Clinical Research | Santa Ana | California | 92701 | United States |
| Care Access - Thousand Oaks | Thousand Oaks | California | 91360 | United States |
| Accel Research Sites - DeLand Clinical Research Unit | DeLand | Florida | 32720 | United States |
| Innovation Medical Research Center - Fort Lauderdale | Fort Lauderdale | Florida | 33316 | United States |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | United States |
| Encore Medical Research | Hollywood | Florida | 33024 | United States |
| West Orange Endocrinology P.A. | Ocoee | Florida | 34761 | United States |
| Care Access - Tampa | Tampa | Florida | 33625 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Accel Research Sites - NeuroStudies Clinical Research Unit | Decatur | Georgia | 30030 | United States |
| Care Access - Decatur | Decatur | Georgia | 30030 | United States |
| Javara - Privia Medical Group Georgia - Savannah | Savannah | Georgia | 31406 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Care Access - New Iberia | New Iberia | Louisiana | 70560 | United States |
| Endocrine and Metabolic Consultants | Rockville | Maryland | 20852 | United States |
| Javara - Privia Medical Group - Silver Spring | Silver Spring | Maryland | 20901 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Boeson Research MSO | Missoula | Montana | 59804 | United States |
| Javara - Nevada Health Centers - Carson City | Carson City | Nevada | 89706 | United States |
| The Machuca Foundation | Las Vegas | Nevada | 89101 | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27514 | United States |
| Javara - Tryon Medical Partners | Charlotte | North Carolina | 28210 | United States |
| Care Access - Fayetteville | Fayetteville | North Carolina | 28314 | United States |
| The Corvallis Clinic, P.C. | Corvallis | Oregon | 97330 | United States |
| Clinical Research of Philadelphia | Philadelphia | Pennsylvania | 19114 | United States |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | United States |
| Activian Clinical Research | Kingwood | Texas | 77339 | United States |
| Texas Valley Clinical Research (TVCR) - Mission | Mission | Texas | 78572 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| CARE - Centro de Alergia y Enfermedades Respiratorias | Buenos Aires | 1414 | Argentina |
| CIPREC | Buenos Aires | C1119ACN | Argentina |
| Centro Médico Viamonte | Buenos Aires | C1120AAC | Argentina |
| Instituto Centenario | CABA | 1204 | Argentina |
| Instituto Médico Catamarca IMEC | Rosario | 2000 | Argentina |
| Centro de Diagnóstico y Rehabilitación (CEDIR) | Santa Fe | 3000 | Argentina |
| Xuanwu Hospital Capital Medical University | Beijing | 100053 | China |
| Peking University Third Hospital | Beijing | 100091 | China |
| Sichuan Provincial People's Hospital | Chengdu | 610072 | China |
| The Second Affiliated Hospital Chongqing Medical University | Chongqing | 400010 | China |
| Zhujiang Hospital | Guangzhou | 510280 | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | 150001 | China |
| The Second People's Hospital of Hefei | Hefei | 230011 | China |
| Jinan Central Hospital | Jinan | 250013 | China |
| The First Affiliated Hospital of Henan University of Science &Technology | Luoyang Shi | 471003 | China |
| Zhongda Hospital Southeast University | Nanjing | 210009 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | 210011 | China |
| The Second Hospital of Tianjin Medical University | Tianjin | 300211 | China |
| MUDr. Alena Vachova | České Budějovice | 37011 | Czechia |
| Nemocnice Cesky Krumlov | Český Krumlov | 381 01 | Czechia |
| Donmed s.r.o. | Ostrava | 710 00 | Czechia |
| Milan Kvapil s.r.o., Diabetologicka ambulance | Prague | 14900 | Czechia |
| Medical Plus | Uherské Hradiště | 686 01 | Czechia |
| InnoDiab Forschung Gmbh | Essen | 45136 | Germany |
| Medizentrum Essen Borbeck | Essen | 45355 | Germany |
| Diabetes Zentrum Wilhelmsburg | Hamburg | 21109 | Germany |
| AmBeNet GmbH | Leipzig | 04107 | Germany |
| Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut | Leipzig | 04249 | Germany |
| Medicover Neuroendokrinologie | Munich | 81667 | Germany |
| RED-Institut GmbH | Oldenburg | 23758 | Germany |
| Hasegawa Medicine Clinic | Chitose | 066-0032 | Japan |
| The Institute of Medical Science, Asahi Life Foundation | Chūōku | 103-0002 | Japan |
| Tokyo-Eki Center-building Clinic | Chūōku | 103-0027 | Japan |
| Fukuwa Clinic | Chūōku | 104-0031 | Japan |
| Tokuyama Clinic | Mihama-ku,Chiba City | 261-0004 | Japan |
| Medical Corporation Heishinkai ToCROM Clinic | Shinjuku-ku | 160-0008 | Japan |
| Medical Corporation Heishinkai OCROM Clinic | Suita-shi | 565-0853 | Japan |
| Olive Takamatsu Medical Clinic | Takamatsu | 760-0076 | Japan |
| Shimokitazawa Tomo Clinic | Tokyo | 155-0031 | Japan |
| Tsuchiura Medical & Health Care Center | Tsuchiura | 300-0012 | Japan |
| Noritake Clinic | Ushiku | 300-1207 | Japan |
| Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic | Yamato-shi | 242-0004 | Japan |
| Yokohama Minoru Clinic | Yokohama | 232-0064 | Japan |
| Puerto Rico Health and Wellness Institute | Dorado | 00646 | Puerto Rico |
| Isis Clinical Research Center | Guaynabo | 00968 | Puerto Rico |
| 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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