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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

Short name ACHIEVE-J

NCTNCT06010004 (opens ClinicalTrials.gov in a new tab)Other id18745Other idJ2A-JE-GZPE
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
401 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
28 Sept 2023
Primary completion
5 Jun 2025
Completion
5 Jun 2025
First posted
24 Aug 2023
Last update posted
30 Jun 2026
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

    ACHIEVE-J

    NCT06010004

    28 Sept 2023 to 5 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OrforglipronDrug

Arms3

  • Experimental

    3 mg Orforglipron

    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.

  • Experimental

    12 mg Orforglipron

    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.

  • Experimental

    36 mg Orforglipron

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame · Baseline to Week 54

    Registry description

    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.

Secondary outcomes(12)

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 52

    Registry description

    HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.

  2. Percentage of Participants Who Achieved HbA1c <7.0%

    Time frame · Week 52

    Registry description

    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.

  3. Percentage of Participants Who Achieved HbA1c ≤6.5%

    Time frame · Week 52

    Registry description

    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.

  4. Percentage of Participants Who Achieved HbA1c <5.7%

    Time frame · Week 52

    Registry description

    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.

  5. Change From Baseline in Fasting Serum Glucose

    Time frame · Baseline, Week 52

  6. Change From Baseline in Body Weight

    Time frame · Baseline, Week 52

  7. Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline

    Time frame · Week 52

    Registry description

    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.

  8. Percentage of Participants Who Achieved Weight Loss of ≥10% From Baseline

    Time frame · Week 52

    Registry description

    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.

  9. Percentage of Participants Who Achieved Weight Loss of ≥15% From Baseline

    Time frame · Week 52

    Registry description

    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.

  10. Change From Baseline in Waist Circumference

    Time frame · Baseline, Week 52

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

    Time frame · Baseline, Week 52

  12. Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)

    Time frame · Baseline, Week 52

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline to Week 54

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

GroupValue (Participants)
3 mg Orforglipron107
12 mg Orforglipron114
36 mg Orforglipron118
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 52

Change From Baseline in Hemoglobin A1c (HbA1c)

GroupValue (percentage of HbA1c)Spread
3 mg Orforglipron-1.710.072
12 mg Orforglipron-1.970.075
36 mg Orforglipron-2.130.073
Secondary outcomeMean· Week 52

Percentage of Participants Who Achieved HbA1c <7.0%

GroupValue (percentage of participants)Spread
3 mg Orforglipron82.733.25
12 mg Orforglipron86.112.86
36 mg Orforglipron90.822.52
Secondary outcomeMean· Week 52

Percentage of Participants Who Achieved HbA1c ≤6.5%

GroupValue (percentage of participants)Spread
3 mg Orforglipron62.644.11
12 mg Orforglipron76.233.57
36 mg Orforglipron84.563.27
Secondary outcomeMean· Week 52

Percentage of Participants Who Achieved HbA1c <5.7%

GroupValue (percentage of participants)Spread
3 mg Orforglipron7.702.20
12 mg Orforglipron21.923.54
36 mg Orforglipron30.513.86
Secondary outcomeLeast squares mean· Baseline, Week 52

Change From Baseline in Fasting Serum Glucose

GroupValue (milligrams per deciliter (mg/dL))Spread
3 mg Orforglipron-51.71.40
12 mg Orforglipron-55.12.86
36 mg Orforglipron-64.51.37
Secondary outcomeLeast squares mean· Baseline, Week 52

Change From Baseline in Body Weight

GroupValue (kilogram (kg))Spread
3 mg Orforglipron-1.810.307
12 mg Orforglipron-5.080.474
36 mg Orforglipron-6.750.509
Secondary outcomeMean· Week 52

Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline

GroupValue (percentage of participants)Spread
3 mg Orforglipron27.003.90
12 mg Orforglipron49.524.40
36 mg Orforglipron65.144.24

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
3 mg OrforglipronParticipants 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.0 / 1324 / 132106 / 132
12 mg OrforglipronParticipants 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.0 / 1353 / 135114 / 135
36 mg OrforglipronParticipants 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.1 / 1346 / 134118 / 134

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

19 results

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.

Yabe et al. 2026The lancet. Diabetes & endocrinologycited by 1

PMID 42607698DOI 10.1016/s2213-8587(26)00138-5PUB-42607698

Full text at the publisher19 results
Publisher pageSee results (19)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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

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