NCT06010004CompletedPhase 3
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
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)
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication. 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 401 (actual)
- First submitted
- 21 Aug 2023
- Start date
- 28 Sept 2023
- Primary completion date
- 5 Jun 2025
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT06010004
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 401
- From 28 Sept 2023 to the primary completion date, 5 Jun 2025
- 40 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
- 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
Other illness
- Have Type 1 Diabetes (T1D).
- Have New York Heart Association functional classification IV congestive heart failure.
- Have acute or chronic hepatitis and pancreatitis
Who the study is looking for
- Have Type 2 Diabetes (T2D)
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seiwa Clinic Coordinator of this site? Confirm its status | Adachi-ku | Japan | Unknown status |
| Hasegawa Medical Clinic Coordinator of this site? Confirm its status | Chitose | Japan | Unknown status |
| The Institute for Adult Disease, Asahi Life Foundation Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Tashiro Endocrinology Clinic Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hachioji Diabetes Clinic Coordinator of this site? Confirm its status | Hachioji-shi | Japan | Unknown status |
| Shonan Takai Clinic Coordinator of this site? Confirm its status | Kamakura | Japan | Unknown status |
| Takai Internal Medicine Clinic Coordinator of this site? Confirm its status | Kamakura-shi | Japan | Unknown status |
| Shiraiwa Medical Clinic Coordinator of this site? Confirm its status | Kashihara | Japan | Unknown status |
| Shinkashiwa Clinic Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Kashiwa City Hospital Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| OHAMA Diabetes Clinic Coordinator of this site? Confirm its status | Kawaguchi | Japan | Unknown status |
| Steel Memorial Yawata Hospital Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| Matsuda Clinic Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Jinnouchi Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Morinaga Ueno Clinic Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Gibo Hepatology Clinic Coordinator of this site? Confirm its status | Matsumoto | Japan | Unknown status |
| Mikannohana Clinic, Diabetes, Endocrinology and Metabolism Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Tokuyama Clinic Coordinator of this site? Confirm its status | Mihama-ku,Chiba City | Japan | Unknown status |
| Kanno Naika Coordinator of this site? Confirm its status | Mitaka | Japan | Unknown status |
| MinamiAkatsukaClinic Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Nakamoto Internal Medicine Clinic Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Heiwadai Hospital Coordinator of this site? Confirm its status | Miyazaki | Japan | Unknown status |
| Nakayama Clinic Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Nishiyamadou Keiwa Hospital Coordinator of this site? Confirm its status | Naka | Japan | Unknown status |
| Nakakinen clinic Coordinator of this site? Confirm its status | Naka | Japan | Unknown status |
| Abe Clinic Coordinator of this site? Confirm its status | Ōita | Japan | Unknown status |
| Kitada Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kansai Electric Power Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Odori Diabetes Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Heishinkai Medical Group ToCROM Clinic Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Sugiura Internal Medicine Clinic Coordinator of this site? Confirm its status | Sōka | Japan | Unknown status |
| Medical Corporation Heishinkai OCROM Clinic Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Taya Clinic Koueikai Medical Corporation Coordinator of this site? Confirm its status | Tsuchiura | Japan | Unknown status |
| Medical Corporation Tao Internal Medicine Clinic Coordinator of this site? Confirm its status | Ube | Japan | Unknown status |
| Fujii Clinic Coordinator of this site? Confirm its status | Ube | Japan | Unknown status |
| Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Coordinator of this site? Confirm its status | Yamato-shi | Japan | Unknown status |
| Yokkaichi Diabetes Clinic Coordinator of this site? Confirm its status | Yokkaichi | Japan | Unknown status |
| Yokohama Minoru Clinic Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.