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Completed 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

Conditions: Type 2 Diabetes

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 546
Sponsor: Eli Lilly and Company

Location: MD First Research - Chandler Chandler Arizona

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.

Eligibility 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06109311). StuddyBuddy aggregates publicly available trial information.