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
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
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.
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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