For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Have Type 2 Diabetes (T2D)
  2. Have HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]
  3. 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:
  1. insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
  2. insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
  3. metformin, or
  4. SGLT-2 inhibitor, or
  5. both metformin and SGLT-2 inhibitor.
  6. 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.
  7. Have a Body Mass Index (BMI) ≥23.0 kg/m^2 at baseline.

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Have New York Heart Association functional classification III-IV congestive heart failure.
  2. Have had any of the following cardiovascular conditions within 60 days prior to baseline.
  1. acute myocardial infarction
  2. cerebrovascular accident (stroke), or
  3. hospitalization for congestive heart failure.
  4. 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
  5. Have had chronic or acute pancreatitis any time.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-317-615-4559Email iconEmail Study Center

Study Details


Contition

Type 2 Diabetes

Age

18+

Phase

PHASE3

Participants Needed

520

Est. Completion Date

Jun 25, 2025

Treatment Type

INTERVENTIONAL


Sponsor

Eli Lilly and Company

ClinicalTrials.gov NCT Identifier

NCT06109311

Study Number

J2A-MC-GZGW

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