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Clinical Trial Details

Trial ID: L2786
Source ID: NCT06010004
Associated Drug: Orforglipron
Title: A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
Acronym: ACHIEVE-J
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Orforglipron
Outcome Measures: Primary: Number of Participants with Treatment Emergent Adverse Events (TEAEs), Baseline through Week 52 | Secondary: Change from Baseline in Hemoglobin A1c (HbA1c), Baseline, Week 52|Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol), Week 52|Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol), Week 52|Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol), Week 52|Change from Baseline in Fasting Serum Glucose, Baseline, Week 52|Change from Baseline in Body Weight, Baseline, Week 52|Percentage of Participants who Achieve Weight Loss of ≥5%, Week 52|Percentage of Participants who Achieve Weight Loss of ≥10%, Week 52|Percentage of Participants who Achieve Weight Loss of ≥15%, Week 52|Change from Baseline in Waist Circumference, Baseline, Week 52|Change from Baseline in Body Mass Index (BMI), Baseline, Week 52|Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG), Baseline, Week 52
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 399
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-28
Completion Date: 2025-06
Results First Posted:
Last Update Posted: 2025-02-28
Locations: Nakayama Clinic, Nagoya, Aichi, 456-0058, Japan|Shinkashiwa Clinic, Kashiwa, Chiba, 277-0084, Japan|Kashiwa City Hospital, Kashiwa, Chiba, 277-0825, Japan|Tokuyama Clinic, Mihama-ku,Chiba City, Chiba, 261-0004, Japan|Mikannohana Clinic, Diabetes, Endocrinology and Metabolism, Matsuyama, Ehime, 790-0034, Japan|Steel Memorial Yawata Hospital, Kitakyushu, Fukuoka, 805-8508, Japan|Hasegawa Medical Clinic, Chitose, Hokkaido, 066-0032, Japan|Odori Diabetes, Sapporo, Hokkaido, 060-0001, Japan|Matsuda Clinic, Kobe, Hyogo, 651-2135, Japan|Nakamoto Internal Medicine Clinic, Mito, Ibaraki, 310-0826, Japan|MinamiAkatsukaClinic, Mito, Ibaraki, 311-4153, Japan|Nakakinen clinic, Naka, Ibaraki, 311-0113, Japan|Nishiyamadou Keiwa Hospital, Naka, Ibaraki, 311-0133, Japan|Taya Clinic Koueikai Medical Corporation, Tsuchiura, Ibaraki, 300-0047, Japan|Takai Internal Medicine Clinic, Kamakura-shi, Kanagawa, 247-0056, Japan|Shonan Takai Clinic, Kamakura, Kanagawa, 247-0055, Japan|Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, 242-0004, Japan|Yokohama Minoru Clinic, Yokohama, Kanagawa, 232-0064, Japan|Yokkaichi Diabetes Clinic, Yokkaichi, Mie, 510-0829, Japan|Gibo Hepatology Clinic, Matsumoto, Nagano, 399-0036, Japan|Shiraiwa Medical Clinic, Kashiwara, Osaka, 582-0005, Japan|Kitada Clinic, Osaka-city, Osaka, 538-0044, Japan|Medical Corporation Heishinkai OCROM Clinic, Suita-shi, Osaka, 565-0853, Japan|OHAMA Diabetes Clinic, Kawaguchi, Saitama, 332-0015, Japan|Sugiura Internal Medicine Clinic, Soka, Saitama, 340-0015, Japan|Seiwa Clinic, Adachi-ku, Tokyo, 120-0011, Japan|The Institute for Adult Disease, 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|Hachioji Diabetes Clinic, Hachioji-shi, Tokyo, 192-0083, Japan|Kanno Naika, Mitaka, Tokyo, 181-0013, Japan|Heishinkai Medical Group ToCROM Clinic, Shinjuku-ku, Tokyo, 160-0008, Japan|Medical Corporation Tao Internal Medicine Clinic, Ube, Yamaguchi, 755-0047, Japan|Fujii Clinic, Ube, Yamaguchi, 755-0049, Japan|Tashiro Endocrinology Clinic, Fukuoka, 814-0153, Japan|Morinaga Ueno Clinic, Kumamoto, 860-0863, Japan|Jinnouchi Hospital, Kumamoto, 862-0976, Japan|Heiwadai Hospital, Miyazaki, 880-0034, Japan|Abe Clinic, Oita, 870-0039, Japan|Kansai Electric Power Hospital, Osaka, 553-0003, Japan
URL: https://clinicaltrials.gov/show/NCT06010004

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress