Effect of Efpeglenatide on Cardiovascular Outcomes
Primary Objective: -To demonstrate that, efpeglenatide doses 1 and 2 is noninferior to placebo on 3-point major adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) patients at high cardiovascular (CV) risk. Secondary Objectives: - To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients with high CV risk on the following parameters: - 3-point MACE. - Expanded CV outcome. - Composite outcome of new or worsening nephropathy. - To assess the safety and tolerability of efpeglenatide doses 1 and 2, both added to standard of care in T2DM patients at high CV risk.
- Type 2 Diabetes Mellitus
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Efpeglenatide Dose 1
|Efpeglenatide dose 1 once weekly||
Efpeglenatide Dose 2
|Efpeglenatide dose 2 once weekly||
|Placebo once weekly||
- Active, not recruiting
The estimated study duration per participant is up to approximately 36 months.