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Clinical Trial Details

Trial ID: L5060
Source ID: NCT06045221
Associated Drug: Orforglipron
Title: A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
Acronym: ACHIEVE-3
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Orforglipron|DRUG: Semaglutide
Outcome Measures: Primary: Change from Baseline in Hemoglobin A1c (HbA1c), Baseline, Week 52 | Secondary: 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), 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
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1576
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-22
Completion Date: 2025-09
Results First Posted:
Last Update Posted: 2025-02-27
Locations: Absolute Clinical Research, Phoenix, Arizona, 85051, United States|San Fernando Valley Health Institute, 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|CIPREC, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1061AAS, Argentina|Centro Médico Viamonte, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1120AAC, Argentina|Instituto Centenario, Caba, Ciudad Autónoma De Buenos Aires, 1204, Argentina|Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, 1405, Argentina|Centro de Salud e Investigaciones Médicas, Santa Rosa, La Pampa, 6300, Argentina|INECO Neurociencias Oroño, Rosario, Santa Fe, 2000, Argentina|Instituto de Especialidades de la Salud Rosario, Rosario, Santa Fe, 2000, Argentina|Instituto Médico Catamarca IMEC, Rosario, Santa Fe, 2000, Argentina|Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica, Rosario, Santa Fe, 2000, Argentina|Fundacion Estudios Clinicos, Rosario, Santa Fe, 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, 101200, China|Chongqing General Hospital, Chongqing, Chongqing, 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, 200030, China|Pudong New Area People's Hospital Shanghai, Shanghai, Shanghai, 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, Kashiwara, Osaka, 582-0005, Japan|Medical Corporation Sato Medical clinic, Ootaku, Tokyo, 143-0015, Japan|Gifu University Hospital, Gifu, 501-1112, Japan|Caimed Investigacion En Salud S.A. de C.V., Mexico City, Distrito Federal, 06760, Mexico|Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, Mexico City, Distrito Federal, 11650, Mexico|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|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., Culiacan, Sinaloa, 80230, Mexico|Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia, Durango, 34000, Mexico|Isis Clinical Research Center, Guaynabo, 00968, Puerto Rico|Research and Cardiovascular Corp., Ponce, 00717, Puerto Rico|Latin Clinical Trial Center, San Juan, 00909, Puerto Rico|Mgcendo Llc, San Juan, 00921, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT06045221