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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
546
Administered orally.
Administered orally.
Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 40
Orforglipron Dose 3: Change from Baseline in HbA1c
Time frame: Baseline, Week 40
Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol))
Time frame: Baseline to Week 40
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)
Time frame: Baseline to Week 40
Change from Baseline in Fasting Serum Glucose
Time frame: Baseline, Week 40
Percentage Change from Baseline in Body Weight
Time frame: Baseline, Week 40
Change from Baseline in Body Weight
Time frame: Baseline, Week 40
Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol
Time frame: Baseline, Week 40
Percentage Change from Baseline in Triglycerides
Time frame: Baseline, Week 40
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 40
Change from Baseline in Daily Insulin Glargine Dose
Time frame: Baseline, Week 40
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Percentage of Participants Who Achieved Weight Loss of ≥5%
Time frame: Baseline to Week 40
Percentage of Participants Who Achieved Weight Loss of ≥10%
Time frame: Baseline to Week 40
Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline
Time frame: Baseline to Week 40
Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores
Time frame: Baseline, Week 40