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Clinical Trial Details

Trial ID: L6990
Source ID: NCT06109311
Associated Drug: Orforglipron
Title: A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
Acronym: ACHIEVE-5
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Orforglipron|DRUG: Placebo
Outcome Measures: Primary: Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c), Baseline, Week 40 | Secondary: Orforglipron Dose 3: Change from Baseline in HbA1c, Baseline, Week 40|Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol)), Baseline to Week 40|Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol), Baseline to 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|Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol, Baseline, Week 40|Percentage Change from Baseline in Triglycerides, Baseline, Week 40|Change from Baseline in Systolic Blood Pressure, Baseline, Week 40|Change from Baseline in Daily Insulin Glargine Dose, Baseline, Week 40|Percentage of Participants Who Achieved Weight Loss of ≥5%, Baseline to Week 40|Percentage of Participants Who Achieved Weight Loss of ≥10%, Baseline to Week 40|Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline, Baseline to Week 40|Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary 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: 2023-11-10
Completion Date: 2025-09
Results First Posted:
Last Update Posted: 2025-02-28
Locations: MD First Research - Chandler, Chandler, Arizona, 85286, United States|Phoenix Clinical LLC, Phoenix, Arizona, 85014, United States|SanRo Clinical Research Group, Bryant, Arkansas, 72022, United States|Velocity Clinical Research, Gardena, Gardena, California, 90247, United States|Loma Linda University Health System, Loma Linda, California, 92350, United States|Western University of Health Sciences, Pomona, California, 91766, United States|Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc., Toluca Lake, California, 91602, United States|CMR of Greater New Haven, LLC, Hamden, Connecticut, 06517, United States|Care Access - Brandon, Brandon, Florida, 33510, United States|Encore Medical Research, Hollywood, Florida, 33024, United States|Encore Medical Research - Weston, Weston, Florida, 33331, United States|Orita Clinical Research, Decatur, Georgia, 30034, United States|Bingham Memorial Hospital, Blackfoot, Idaho, 83221, United States|St. Luke's Humphreys Diabetes Center: Boise, Boise, Idaho, 83702, United States|Cotton O'Neil Diabetes & Endocrinology, Topeka, Kansas, 66606, United States|The Research Group of Lexington, Lexington, Kentucky, 40503, United States|Clinvest Headlands Llc, Springfield, Missouri, 65807, United States|Richmond University Medical Center, Staten Island, New York, 10310, United States|Velocity Clinical Research, Mt. Auburn, Cincinnati, Ohio, 45219, United States|Velocity Clinical Research, Medford, Medford, Oregon, 97504, United States|Tristar Clinical Investigations, Philadelphia, Pennsylvania, 19114, United States|Frontier Clinical Research, LLC, Scottdale, Pennsylvania, 15683, United States|Lifedoc Research - Lenox Park Drive, Memphis, Tennessee, 38115, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Texas Valley Clinical Research, Weslaco, Texas, 78596, United States|L2IP - Instituto de Pesquisas Clínicas, Brasília, Distrito Federal, 70200730, Brazil|CEDOES, Vitória, Espírito Santo, 29055450, Brazil|Quanta Diagnóstico e Terapia, Curitiba, Paraná, 80040-110, Brazil|Insight Centro de Pesquisas, Porto Alegre, Rio Grande Do Sul, 90560-003, Brazil|Centro de Pesquisa Sao Lucas, Campinas, São Paulo, 13060-803, Brazil|Centro Multidisciplinar de Estudos Clinicos, Sao Bernardo do Campo, São Paulo, 09715-090, Brazil|ISPEM - Instituto São José dos Campos em Pesquisas Médicas, São José dos Campos, São Paulo, 12243-280, Brazil|IBPClin - Instituto Brasil de Pesquisa Clínica, Rio de Janeiro, 20241-180, Brazil|CPQuali Pesquisa Clínica, São Paulo, 01228-000, Brazil|The Second People's Hospital of Hefei, Hefei, Anhui, 230011, China|Wannan Medical College Yijishan Hospital, Wuhu, Anhui, 241001, China|Beijing Hospital, Beijing, Beijing, 100051, China|Chongqing General Hospital, Chongqing, Chongqing, 401147, 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|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China|Nanjing First Hospital, Nanjing, Jiangsu, 210012, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212000, China|Jinan Central Hospital, Jinan, Shandong, 250013, China|Tokuyama Clinic, Mihama-ku,Chiba City, Chiba, 261-0004, Japan|Hasegawa Medical Clinic, Chitose, Hokkaido, 066-0032, Japan|MinamiAkatsukaClinic, Mito, Ibaraki, 311-4153, Japan|Matoba Internal Medicine Clinic, Ebina, Kanagawa, 243-0432, Japan|Takai Internal Medicine Clinic, Kamakura-shi, Kanagawa, 247-0056, Japan|Shiraiwa Medical Clinic, Kashiwara, Osaka, 582-0005, 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|Medical Corporation Sato Medical clinic, Ootaku, Tokyo, 143-0015, Japan|Tama Center Clinic Mirai, Tama, Tokyo, 206-0633, Japan|Jinnouchi Hospital, Kumamoto, 862-0976, Japan|Abe Clinic, Oita, 870-0039, Japan|Kansai Electric Power Hospital, Osaka, 553-0003, Japan|Centro de Endocrinologia y Nutricion, Caguas, 00725, Puerto Rico|FDI Clinical Research, San Juan, 00927, Puerto Rico|Diabdana, Oradea, Bihor, 410147, Romania|C.M.D.T.A. Neomed, Brasov, Brașov, 500283, Romania|Geea Medical Easy Diet, Bucharest, București, 010627, Romania|Centrul Medical NutriLife, Bucharest, București, 013764, Romania|Centrul Medical Endocrinologie si Diabet Dr. Paveliu, Bucharest, București, 50538, Romania|CMI DNBM Dr. Pop Lavinia, Baia Mare, Maramureș, 430222, Romania|SC Dentosim Queen SRL - Centrul Medical Diamed, Târgu Mureș, Mureș, 540098, Romania|Milena Sante, Galați, 800001, Romania|Diamed Obesity, Galați, 800291, Romania|Clinica Korall, Satu Mare, 440055, Romania
URL: https://clinicaltrials.gov/show/NCT06109311

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress