Skip to main content
OpenTrials
Completed

NCT Number: NCT06010004

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nakayama Clinic, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Primary outcomes

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

    Time frame: Baseline to Week 54

    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

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 52

    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

    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

    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

    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

    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

    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

    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

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Acronym: ACHIEVE-J

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.