The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication. This study includes 3 periods as follows: * screening and lead-in period: up to 4 weeks * treatment period: 52 weeks, including 20 weeks of dose escalation, and * safety follow-up period: 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
401
Administered orally
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.
Time frame: Baseline to Week 54
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Time frame: Baseline, Week 52
Percentage of Participants Who Achieved HbA1c <7.0%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Time frame: Week 52
Percentage of Participants Who Achieved HbA1c ≤6.5%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Time frame: Week 52
Percentage of Participants Who Achieved HbA1c <5.7%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
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Time frame: Week 52
Change From Baseline in Fasting Serum Glucose
Time frame: Baseline, Week 52
Change From Baseline in Body Weight
Time frame: Baseline, Week 52
Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline
The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Time frame: Week 52
Percentage of Participants Who Achieved Weight Loss of ≥10% From Baseline
The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Time frame: Week 52
Percentage of Participants Who Achieved Weight Loss of ≥15% From Baseline
The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.
Time frame: Week 52
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 52
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 52
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)
SMBG is measured using a glucometer. The SMBG profiles will consist of the following 7-point measurements obtained on a single day: * before 3 main meals, * approximately 2 hours after 3 main meals, and * at bedtime Daily average glucose was calculated as the mean of 7 time point specific averages obtained from up to 2 non-consecutive SMBG profiles within week 52.
Time frame: Baseline, Week 52