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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Other trials in Japan

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 groups in NCT06010004
Study groupRoleWhat they receive
3 mg OrforglipronExperimentalParticipants 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 OrforglipronExperimentalParticipants 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 OrforglipronExperimentalParticipants 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. Change From Baseline in Fasting Serum Glucose

    Measured: Baseline, Week 52

  6. Change From Baseline in Body Weight

    Measured: Baseline, Week 52

  7. 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

  8. 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

  9. 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

  10. Change From Baseline in Waist Circumference

    Measured: Baseline, Week 52

  11. Change From Baseline in Body Mass Index (BMI)

    Measured: Baseline, Week 52

  12. 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.

  1. First posted24 Aug 2023
  2. Study start28 Sep 2023
  3. Primary completion5 Jun 2025
  4. Study completion5 Jun 2025

Resources

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)
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
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orforglipron in people with Type 2 Diabetes, run by Eli Lilly and Company at 40 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline to Week 54). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06010004, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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