Type 2 Diabetes
Conditions
Brief 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.
Interventions
DRUGOrforglipron
Administered orally.
DRUGPlacebo
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 40 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol) | Baseline to Week 40 |
| Change from Baseline in Fasting Serum Glucose | Baseline, Week 40 |
| Percentage Change from Baseline in Body Weight | Baseline, Week 40 |
| Change from Baseline in Body Weight | Baseline, Week 40 |
| Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol | Baseline, Week 40 |
| Orforglipron Dose 3: Change from Baseline in HbA1c | Baseline, Week 40 |
| Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol)) | Baseline to Week 40 |
| Change from Baseline in Systolic Blood Pressure | Baseline, Week 40 |
| Change from Baseline in Daily Insulin Glargine Dose | Baseline, Week 40 |
| Percentage of Participants Who Achieved Weight Loss of ≥5% | Baseline to Week 40 |
| Percentage of Participants Who Achieved Weight Loss of ≥10% | Baseline to Week 40 |
| Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline | Baseline to Week 40 |
| Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores | Baseline, Week 40 |
| Percentage Change from Baseline in Triglycerides | Baseline, Week 40 |
Countries
Brazil, China, Japan, Puerto Rico, Romania, United States
Outcome results
None listed