Type 2 DiabetesPhase 3ACHIEVE-JNCT06010004
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
A Phase 3 study testing Orforglipron in people with Type 2 Diabetes, run by Eli Lilly and Company at 40 sites in Japan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Orforglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 40 sitesJapan
- Study dates
- 28 Sep 2023to 5 Jun 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have Type 1 Diabetes (T1D).
- 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Japan40 sites
Seiwa Clinic
Adachi-ku, Tokyo, 120-0011
Hasegawa Medical Clinic
Chitose, Hokkaido, 066-0032
The Institute for Adult Disease, Asahi Life Foundation
Chuo-ku, Tokyo, 103-0002
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
Tashiro Endocrinology Clinic
Fukuoka, 814-0153
Hachioji Diabetes Clinic
Hachioji-shi, Tokyo, 192-0083
Shonan Takai Clinic
Kamakura, Kanagawa, 247-0055
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056
Shiraiwa Medical Clinic
Kashihara, Osaka, 582-0005
Shinkashiwa Clinic
Kashiwa, Chiba, 277-0084
Kashiwa City Hospital
Kashiwa, Chiba, 277-0825
OHAMA Diabetes Clinic
Kawaguchi, Saitama, 332-0015
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, 805-8508
Matsuda Clinic
Kobe, Hyōgo, 651-2135
Morinaga Ueno Clinic
Kumamoto, 860-0863
Jinnouchi Hospital
Kumamoto, 862-0976
Gibo Hepatology Clinic
Matsumoto, Nagano, 399-0036
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, Ehime, 790-0034
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba, 261-0004
Kanno Naika
Mitaka, Tokyo, 181-0013
Nakamoto Internal Medicine Clinic
Mito, Ibaraki, 310-0826
MinamiAkatsukaClinic
Mito, Ibaraki, 311-4153
Heiwadai Hospital
Miyazaki, 880-0034
Nakayama Clinic
Nagoya, Aichi-ken, 456-0058
Nakakinen clinic
Naka, Ibaraki, 311-0113
Nishiyamadou Keiwa Hospital
Naka, Ibaraki, 311-0133
Abe Clinic
Ōita, 870-0039
Kitada Clinic
Osaka, Osaka, 538-0044
Kansai Electric Power Hospital
Osaka, 553-0003
Odori Diabetes
Sapporo, Hokkaido, 060-0001
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008
Sugiura Internal Medicine Clinic
Sōka, Saitama, 340-0015
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853
Taya Clinic Koueikai Medical Corporation
Tsuchiura, Ibaraki, 300-0047
Medical Corporation Tao Internal Medicine Clinic
Ube, Yamaguchi, 755-0047
Fujii Clinic
Ube, Yamaguchi, 755-0049
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa, 242-0004
Yokkaichi Diabetes Clinic
Yokkaichi, Mie-ken, 510-0829
Yokohama Minoru Clinic
Yokohama, Kanagawa, 232-0064
About this study
Official title: 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)
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Orforglipron
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrforglipronDrug
Also called LY3502970
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 3 mg Orforglipron | Experimental | Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration. Receives: Drug: Orforglipron |
| 12 mg Orforglipron | Experimental | Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration. Receives: Drug: Orforglipron |
| 36 mg Orforglipron | Experimental | Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration. Receives: Drug: Orforglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.
Measured: Baseline to Week 54
Secondary outcomes (12)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Baseline, Week 52
Percentage of Participants Who Achieved HbA1c <7.0%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Measured: Week 52
Percentage of Participants Who Achieved HbA1c ≤6.5%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Measured: Week 52
Percentage of Participants Who Achieved HbA1c <5.7%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Measured: Week 52
Change From Baseline in Fasting Serum Glucose
Measured: Baseline, Week 52
Change From Baseline in Body Weight
Measured: Baseline, Week 52
Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline
The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Measured: Week 52
Percentage of Participants Who Achieved Weight Loss of ≥10% From Baseline
The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Measured: Week 52
Percentage of Participants Who Achieved Weight Loss of ≥15% From Baseline
The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Measured: Week 52
Change From Baseline in Waist Circumference
Measured: Baseline, Week 52
Change From Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 52
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)
SMBG is measured using a glucometer. The SMBG profiles will consist of the following 7-point measurements obtained on a single day:
- before 3 main meals,
- approximately 2 hours after 3 main meals, and
- at bedtime
Daily average glucose was calculated as the mean of 7 time point specific averages obtained from up to 2 non-consecutive SMBG profiles within week 52.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start28 Sep 2023
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010004
- Sponsor's protocol ID
- 18745
- Other IDs
- J2A-JE-GZPE
- Acronym
- ACHIEVE-J
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2023
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Yabe D, Shiraiwa T, Ugai H, Takeuchi M, Suzuki R. Long-term safety of oral orforglipron in Japanese participants with type 2 diabetes (ACHIEVE-J): a multicentre, randomised, open-label, parallel-group phase 3 trial. Lancet Diabetes Endocrinol. 2026 Aug 17:S2213-8587(26)00138-5. doi: 10.1016/S2213-8587(26)00138-5. Online ahead of print.
PubMed 42607698