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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521098-14-00 | EU Trial (CTIS) Number | ||
| J2A-MC-GZP1 | Other Identifier | Eli Lilly and Company | |
| J2A-MC-GZPO | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792).
Participation in the study will last about 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron Dose 1 | Experimental | Participants will receive orforglipron orally |
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| Orforglipron Dose 2 | Experimental | Participants will receive orforglipron orally |
|
| Orforglipron Dose 3 | Experimental | Participants will receive orforglipron orally |
|
| Orforglipron Dose 4 | Experimental | Participants will receive orforglipron orally |
|
| Placebo | Placebo Comparator | Participants will receive placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Weight Reduction of ≥5% | Baseline up to 72 weeks | |
| Change from Baseline in Waist Circumference | Baseline up to 72 weeks | |
| Change from Baseline in Body Mass Index (BMI) |
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Inclusion Criteria:
Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:
Have a history of at least one unsuccessful dietary effort to lose body weight
Exclusion Criteria:
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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 | ||
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| Label | URL |
|---|---|
| A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity (GZPO) | 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 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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|
| Placebo | Drug | Administered orally |
|
| Baseline, Week 72 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline up to 72 weeks |
| Percent Change from Baseline in Triglycerides | Baseline up to 72 weeks |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline up to 72 weeks |
| Change from Baseline in Fasting Glucose | Baseline up to 72 weeks |
| Change from Baseline in EQ-5D-5L | Baseline, Week 72 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron | Predose through Week 48 |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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