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

• Status: Recruiting
• Trial end date: 2025-06-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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:

• 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.