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OpenTrials
Completed

NCT Number: NCT06109311

A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEDOES, Vitória, Espírito Santo, Brazil

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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]
  • Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:
  • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
  • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
  • metformin, or
  • SGLT-2 inhibitor, or
  • both metformin and SGLT-2 inhibitor.
  • Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 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 Body Mass Index (BMI) ≥23.0 kg/m^2 at baseline.

Exclusion criteria

  • Have New York Heart Association functional classification III-IV congestive heart failure.
  • Have had any of the following cardiovascular conditions within 60 days prior to baseline.
  • acute myocardial infarction
  • cerebrovascular accident (stroke), or
  • hospitalization for congestive heart failure.
  • Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
  • Have had chronic or acute pancreatitis any time.

Treatment and study plan

Orforglipron

Drug

Administered orally.

Other names: LY3502970

Placebo

Drug

Administered orally.

Primary outcomes

  1. Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 40

Secondary outcomes

  1. Orforglipron Dose 3: Change from Baseline in HbA1c

    Time frame: Baseline, Week 40

  2. Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol))

    Time frame: Baseline to Week 40

  3. Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)

    Time frame: Baseline to Week 40

  4. Change from Baseline in Fasting Serum Glucose

    Time frame: Baseline, Week 40

  5. Percentage Change from Baseline in Body Weight

    Time frame: Baseline, Week 40

  6. Change from Baseline in Body Weight

    Time frame: Baseline, Week 40

  7. Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol

    Time frame: Baseline, Week 40

  8. Percentage Change from Baseline in Triglycerides

    Time frame: Baseline, Week 40

  9. Change from Baseline in Systolic Blood Pressure

    Time frame: Baseline, Week 40

  10. Change from Baseline in Daily Insulin Glargine Dose

    Time frame: Baseline, Week 40

  11. Percentage of Participants Who Achieved Weight Loss of ≥5%

    Time frame: Baseline to Week 40

  12. Percentage of Participants Who Achieved Weight Loss of ≥10%

    Time frame: Baseline to Week 40

  13. Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline

    Time frame: Baseline to Week 40

  14. Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores

    Time frame: Baseline, Week 40

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Acronym: ACHIEVE-5

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2023
Registry last updated
Oct 20, 2025

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.

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