A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
NCT ID: NCT06010004
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
466 participants
INTERVENTIONAL
2023-09-28
2025-06-05
Brief Summary
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This study includes 3 periods as follows:
* screening and lead-in period: up to 4 weeks
* treatment period: 52 weeks, including 20 weeks of dose escalation, and
* safety follow-up period: 2 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Orforglipron Dose 1
Participants will receive orforglipron administered orally.
Orforglipron
Administered orally
Orforglipron Dose 2
Participants will receive orforglipron administered orally.
Orforglipron
Administered orally
Orforglipron Dose 3
Participants will receive orforglipron administered orally.
Orforglipron
Administered orally
Interventions
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Orforglipron
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening.
* Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
* Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.
Exclusion Criteria
* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
* Have New York Heart Association functional classification IV congestive heart failure.
* Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.
* acute myocardial infarction
* cerebrovascular accident (stroke), or
* hospitalization for congestive heart failure
* Have acute or chronic hepatitis and pancreatitis
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Nakayama Clinic
Nagoya, Aichi-ken, Japan
Shinkashiwa Clinic
Kashiwa, Chiba, Japan
Kashiwa City Hospital
Kashiwa, Chiba, Japan
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba, Japan
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, Ehime, Japan
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, Japan
Hasegawa Medical Clinic
Chitose, Hokkaido, Japan
Odori Diabetes
Sapporo, Hokkaido, Japan
Matsuda Clinic
Kobe, Hyōgo, Japan
Nakamoto Internal Medicine Clinic
Mito, Ibaraki, Japan
MinamiAkatsukaClinic
Mito, Ibaraki, Japan
Nakakinen clinic
Naka, Ibaraki, Japan
Nishiyamadou Keiwa Hospital
Naka, Ibaraki, Japan
Taya Clinic Koueikai Medical Corporation
Tsuchiura, Ibaraki, Japan
Shonan Takai Clinic
Kamakura, Kanagawa, Japan
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, Japan
Yokkaichi Diabetes Clinic
Yokkaichi, Mie-ken, Japan
Gibo Hepatology Clinic
Matsumoto, Nagano, Japan
Shiraiwa Medical Clinic
Kashihara, Osaka, Japan
Kitada Clinic
Osaka, Osaka, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan
OHAMA Diabetes Clinic
Kawaguchi, Saitama, Japan
Sugiura Internal Medicine Clinic
Sōka, Saitama, Japan
Seiwa Clinic
Adachi-ku, Tokyo, Japan
The Institute for Adult Disease, Asahi Life Foundation
Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Hachioji Diabetes Clinic
Hachioji-shi, Tokyo, Japan
Kanno Naika
Mitaka, Tokyo, Japan
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
Medical Corporation Tao Internal Medicine Clinic
Ube, Yamaguchi, Japan
Fujii Clinic
Ube, Yamaguchi, Japan
Tashiro Endocrinology Clinic
Fukuoka, , Japan
Morinaga Ueno Clinic
Kumamoto, , Japan
Jinnouchi Hospital
Kumamoto, , Japan
Heiwadai Hospital
Miyazaki, , Japan
Kansai Electric Power Hospital
Osaka, , Japan
Abe Clinic
Ōita, , Japan
Countries
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Related Links
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A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)
Other Identifiers
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J2A-JE-GZPE
Identifier Type: OTHER
Identifier Source: secondary_id
18745
Identifier Type: -
Identifier Source: org_study_id
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