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