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Clinical Trial Details

Trial ID: L3574
Source ID: NCT05971940
Associated Drug: Orforglipron
Title: A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Acronym: ACHIEVE-1
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Orforglipron|DRUG: Placebo
Outcome Measures: Primary: Change from Baseline in Hemoglobin A1c (HbA1c), Baseline, Week 40 | Secondary: Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol), Week 40|Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol), Week 40|Change from Baseline in Fasting Serum Glucose, Baseline, Week 40|Percentage Change from Baseline in Body Weight, Baseline, Week 40|Change from Baseline in Body Weight, Baseline, Week 40|Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG), Baseline, Week 40|Change from Baseline in Systolic Blood Pressure (SBP), Baseline, Week 40|Change from Baseline in Non-HDL Cholesterol, Baseline, Week 40|Percentage Change from Baseline in Triglycerides, Baseline, Week 40|Percentage of Participants Who Achieved Weight Loss of ≥5%, Week 40|Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores, Baseline, Week 40
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 520
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-08-09
Completion Date: 2025-04
Results First Posted:
Last Update Posted: 2025-02-27
Locations: Syed Research Consultants Llc, Sheffield, Alabama, 35660, United States|Epic Medical Research - Surprise, Surprise, Arizona, 85378, United States|Quality of Life Medical & Research Center, Tucson, Arizona, 85712, United States|Neighborhood Healthcare Institute of Health, Escondido, California, 92025, United States|Velocity Clinical Research, Huntington Park, Huntington Park, California, 90255, United States|Ark Clinical Research, Long Beach, California, 90815, United States|Velocity Clinical Research, Westlake, Los Angeles, California, 90057, United States|Infinity Clinical Research - Norco, Norco, California, 92860, United States|Norcal Endocrinology & Internal Medicine, San Ramon, California, 94583, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Connecticut Clinical Research - Cromwell, Cromwell, Connecticut, 06416, United States|Invictus Clinical Research Group, Coconut Creek, Florida, 33073, United States|Hillcrest Medical Research, DeLand, Florida, 32720, United States|K2 Medical Research, Maitland, Florida, 32751, United States|Global Health Research Center, Inc., Miami Lakes, Florida, 33016, United States|West Orange Endocrinology, Ocoee, Florida, 34761, United States|Clinical Research Atlanta, Stockbridge, Georgia, 30281, United States|Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia, 30291, United States|Family First Medical Center, Idaho Falls, Idaho, 83404, United States|American Health Network of Indiana, LLC - Muncie, Muncie, Indiana, 47304, United States|Tekton Research - Wichita, Wichita, Kansas, 67218, United States|Alliance for Multispecialty Research, LLC, New Orleans, Louisiana, 70119, United States|Revival Research Institute, Dearborn, Michigan, 48126, United States|Billings Clinic, Billings, Montana, 59101, United States|Ellipsis Research Group - Brooklyn - 7th Street, Brooklyn, New York, 11215, United States|Central New York Clinical Research, Manlius, New York, 13104, United States|Monroe Biomedical Research, Monroe, North Carolina, 28112, United States|Lucas Research - New Bern, New Bern, North Carolina, 28562, United States|Centricity Research Dublin Multispecialty, Dublin, Ohio, 43016, United States|Alliance for Multispecialty Research, LLC, Norman, Oklahoma, 73069, United States|The Corvallis Clinic, P.C., Corvallis, Oregon, 97330, United States|Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair, Pittsburgh, Pennsylvania, 15243, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|The Research Center of The Upstate, Greenville, South Carolina, 29607, United States|MDFirst Research, LLC, Lancaster, South Carolina, 29720, United States|The Jackson Clinic, Jackson, Tennessee, 38305, United States|Velocity Clinical Research, Dallas, Dallas, Texas, 75230, United States|Juno Research, Houston, Texas, 77040, United States|Endocrine Ips, Pllc, Houston, Texas, 77079, United States|Amir A Hassan, MD, PA, Houston, Texas, 77089, United States|Burke Internal Medicine and Research, Burke, Virginia, 22015, United States|Wannan Medical College Yijishan Hospital, Wuhu, Anhui, 241001, China|Luhe Hospital, Beijing, Beijing, 100000, China|Beijing Hospital, Beijing, Beijing, 100730, China|Beijing Pinggu District Hospital, Beijing, Beijing, 101200, China|Shunde Hospital of Southern Medical Univesity, Foshan, Guangdong, 528399, China|Huizhou Municipal Central Hospital, Huizhou, Guangdong, 516001, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China|Nanyang First People's Hospital, Nanyang, Henan, 473001, 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|Jinan Central Hospital, Jinan, Shandong, 250013, China|Pudong New Area People's Hospital Shanghai, Shanghai, Shanghai, 201200, China|West China Hospital of Sichuan University, Cheng Du, Sichuan, 610041, China|GMERS Medical College and General Hospital, Baroda, Gujarat, 390021, India|M S Ramaiah Medical College and Hospitals, Bangalore, Karnataka, 560054, India|Medstar Speciality Hospital, Bangalore, Karnataka, 560092, India|BSES MG Hospital, Mumbai, Maharashtra, 400058, India|All India Institute of Medical Sciences (AIIMS) - Nagpur, Nagpur, Maharashtra, 441108, India|Grant Medical Foundation - Ruby Hall Clinic, Pune, Maharashtra, 411001, India|Madras Diabetes Research Foundation, Chennai, Tamil Nadu, 600086, India|Kumudini Devi Diabetes Research Center, Hyderabad, Telangana, 500072, India|Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, 700020, India|Tokuyama Clinic, Mihama-ku,Chiba City, Chiba, 261-0004, Japan|Steel Memorial Yahata Hospital, Kitakyushu, Fukuoka, 805-8508, Japan|Hasegawa Medical Clinic, Chitose, Hokkaido, 066-0032, Japan|MinamiAkatsukaClinic, Mito, Ibaraki, 311-4153, Japan|Iwamoto Clinic, Zentsuji, Kagawa, 765-0071, Japan|Hayashi Diabetes Internal Medicine Clinic, Chigasaki, Kanagawa, 253-0044, Japan|Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, 242-0004, Japan|Medical Corporation Heishinkai OCROM Clinic, Suita-shi, Osaka, 565-0853, Japan|The Institute of Medical Science, Asahi Life Foundation, Chuo-ku, Tokyo, 103-0002, Japan|Tokyo-Eki Center-building Clinic, Chuo-ku, Tokyo, 103-0027, Japan|Fukuwa Clinic, Chuo-ku, Tokyo, 104-0031, Japan|Heishinkai Medical Group ToCROM Clinic, Shinjuku-ku, Tokyo, 160-0008, Japan|Morinaga Ueno Clinic, Kumamoto, 860-0863, Japan|Abe Clinic, Oita, 870-0039, Japan|Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente, Guadalajara, Jalisco, 44150, Mexico|Centro de Investigacion Medica Integral, Guadalajara, Jalisco, 44160, Mexico|Salud Cardiovascular, Guadalajara, Jalisco, 44860, Mexico|Centro de Investigacion Medica de Occidente, S.C., Zapopan, Jalisco, 44260, Mexico|Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos, Chihuahua, 31110, Mexico|PanAmerican Clinical Research - Querétaro - Avenida Antea, Querétaro, 76100, Mexico|Instituto Veracruzano en Investigación Clínica S.C., Veracruz, 91851, Mexico|FAICIC S. de R.L. de C.V., Veracruz, 91900, Mexico|Puerto Rico Health Institute, Dorado, 00646, Puerto Rico|Advance Medical Research Center, San Juan, 00926, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT05971940

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress