The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,749
Administered orally once daily
Administered SC once daily
Alliance for Multispecialty Research, LLC
Daphne, Alabama, United States
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
Cahaba Research - Pelham
Pelham, Alabama, United States
Syed Research Consultants Llc
Sheffield, Alabama, United States
The Institute for Liver Health
Chandler, Arizona, United States
Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]
Time to First Occurrence of Any MACE-4 (Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular \[CV\] Death)
Time frame: Baseline to End of the Study (Approximate Maximum 104 Weeks)
Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)
Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)
Time frame: Baseline to End of the Study (Approximately 104 Weeks)
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in HbA1c
Time frame: Baseline, Week 52
Change from Baseline in Fasting Serum Glucose
Change from Baseline in Fasting Serum Glucose
Time frame: Baseline, Week 52
Change from Baseline in Daily Average 7-point Self-monitoring Blood Glucose (SMBG) Profile
Change from Baseline in Daily Average 7-point SMBG
Time frame: Baseline, Week 52
Percentage of Participants with HbA1c Target Values Less Than (<)7.0% (53 mmol/mol)
Percentage of Participants with HbA1c Target Values \<7.0% (53 mmol/mol)
Time frame: Week 52
Change from Baseline in Body Weight
Change from Baseline in Body Weight
Time frame: Baseline, Week 52
Percent Change from Baseline Body Weight
Percent Change from Baseline Body Weight
Time frame: Week 52
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score
The SF-36v2 acute form is a 36-item generic, participant completed measure designed to assess 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores of each domain are measured by T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health.
Time frame: Baseline, Week 52
Pharmacokinetics (PK): Plasma Serum Concentrations of Orforglipron
PK will be estimated based on the population PK model.
Time frame: Baseline through Week 52
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Aventiv Research
Mesa, Arizona, United States
Arizona Liver Health - Peoria
Peoria, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Absolute Clinical Research
Phoenix, Arizona, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, United States
...and 348 more locations