The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
559
Administered orally.
Administered orally
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 40
Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)
Time frame: Week 40
Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol)
Time frame: 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
Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)
Time frame: Baseline, Week 40
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 40
Change from Baseline in Non-HDL Cholesterol
Time frame: Baseline, Week 40
Percentage Change from Baseline in Triglycerides
Time frame: Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss of ≥5%
Time frame: Week 40
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Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores
Time frame: Baseline, Week 40