Effect of Efpeglenatide on Cardiovascular Outcomes

The estimated study duration per participant is up to approximately 36 months.

Inclusion criteria:

- Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) > 7%.

- Age 18 years or older with established cardiovascular disease or age 50 years (male),
55 years (female) or older with eGFR ≥25 and <60 mL/min and at least one
cardiovascular risk factor.

- Female patients must agree to follow contraceptive guidance.

- Signed written informed consent.

Exclusion criteria:

- Clinically relevant history of gastrointestinal disease associated with prolonged
nausea and vomiting.

- History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any
type of acute pancreatitis within 3 months prior to screening.

- Personal or family history of medullary thyroid cancer (MTC).

- Hypertension (with a systolic blood pressure >180 mmHg and/or diastolic blood pressure
>100 mmHg).

- Hospitalization for hypertensive emergency within 3 months prior to randomization.

- Planned coronary procedure or surgery after randomization.

- No documented ophthalmologic exam with fundoscopy within 6 months prior to
randomization.

- Retinopathy or maculopathy with treatment, either recent (3 months prior to
randomization) or planned during the study.

- Treated with any glucagon-like peptide-1 (GLP-1) receptor agonist product alone (eg,
exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in
combination within 3 months prior to screening.

- Use of any DPP4 inhibitor within 3 months prior to screening.

- Antihyperglycemic treatment has not been stable within 3 months prior to screening.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.