Overview

Effect of Efpeglenatide on Cardiovascular Outcomes

Status:
Terminated
Trial end date:
2020-12-10
Target enrollment:
Participant gender:
Summary
Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Secondary Objectives: To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants 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 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Collaborator:
Hanmi Pharmaceutical Company Limited
Treatments:
Efpeglenatide