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Effect of Efpeglenatide on Cardiovascular Outcomes

NCT03496298 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4076

Last updated 2021-10-15

Study results available
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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.

Conditions

Interventions

DRUG

Efpeglenatide (SAR439977)

Pharmaceutical form: Solution for injection, Route of administration: SC

DRUG

Placebo

Pharmaceutical form: Solution for injection Route of administration: SC

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2020-12-10
Completion
2020-12-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Chile
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Hungary
  • India
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Norway
  • Peru
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03496298 on ClinicalTrials.gov