| Age and type of participant and disease characteristics
1. 50 or more years of age.
2. Have established ASCVD and/or CKD based on the participants’ medical records, including at least one of the following (a through d):
a. Coronary artery disease with ANY of the following:
- previous MI, or
- previous surgical or percutaneous coronary revascularization procedure.
b. Cerebrovascular disease with ANY of the following:
- previous ischemic stroke
- carotid arterial disease with 50% or more stenosis, documented by carotid ultrasound, MRI, or angiography, or
- carotid stenting or surgical revascularization.
c. PAD with ANY of the following:
- previous intermittent claudication supported by ankle-brachial index less than 0.85 measured before Visit 2 completion
- stenosis of 50% or more, or
- prior amputation or peripheral revascularization, for example, stenting or surgical revascularization, due to PAD.
d. CKD diagnosis with historical laboratory values and central laboratory results at Visit 1 meeting one of the following criteria:
- eGFR less than 60 mL/min/1.73 m2 and UACR greater than 30 mg/g (0.03 mg/mg), or
- eGFR less than 75 mL/min/1.73 m2 and UACR greater than 300 mg/g (0.300 mg/mg).
Note: eGFR is calculated by the central laboratory using the CKD-EPIcreat-cystC equation.
Note: Participants with CKD should be treated per local SOC (for example, angiotensin-converting enzyme [ACE] inhibitors or angiotensin II receptor blockers [ARBs]) unless the participant is intolerant to the agents, or they are contraindicated. Dosing should be stable with no dose change for at least 30 days prior to Visit 1. |
Medical conditions
Diabetes related
1. Have type 1 diabetes (T1D), history of 1 or more episodes of ketoacidosis, hyperosmolar state, or coma, within the last 6 months prior to Visit 1 or between Visits 1 and 2.
2. Have a history of 1 or more episodes of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to Visit 1 or between Visits 1 and 2.
3. Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor [VEGF] treatment). Note: In the presence of any degree of diabetic retinopathy and/or macular edema, further ophthalmologic assessment will follow local SOC to confirm eligibility. Participants who have diabetic retinopathy or macular edema recommended for acute intervention should be excluded.
4. Have HbA1c greater than 10.0% as determined by the central laboratory at screening (Visit 1).
5. Are on antihyperglycemic agents (including for non-T2D indications, such as HF or CKD) that have not been stable for at least 90 days prior to screening (Visit 1).
Note: Stable treatment is defined as no new antihyperglycemic agents initiated or discontinued within 90 days prior to screening (Visit 1).
CV related
6. Have any one of the following CV conditions within 60 days prior to randomization (Visit 2):
- MI
- acute coronary syndrome
- stroke, or
- coronary, peripheral, or carotid artery arterial revascularization procedure.
7. Have acute decompensated HF requiring hospitalization or urgent visit within 60 days prior to randomization (Visit 2).
8. Have a planned coronary, carotid, or peripheral artery revascularization procedure known at the time of randomization (Visit 2).
9. Have NYHA Functional Classification Class IV HF at screening (Visit 1).
Kidney related
10. Have eGFR (CKD-EPIcreat-cystC equation) less than 20 mL/min/1.73 m2 at screening (Visit 1). |
80 and over: 80+ Year,Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
50 Year(s) |
100 Year(s) |
Both |