Last updated on July 2019

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise


Brief description of study

Primary Objective:

To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise.

Secondary Objectives:

  • To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control
  • To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight
  • To evaluate the safety of once-weekly injection of efpeglenatide

Detailed Study Description

Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.

Clinical Study Identifier: NCT03353350

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Investigational Site Number 8400032

West Palm Beach, FL United States
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Investigational Site Number 8400025

Lawrenceville, GA United States
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Recruitment Status: Open


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