NCT02788747

Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of Multiple Subcutaneous Injections of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Stealth BioTherapeutics Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF).

Detailed description

This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF). After completing the Screening period, a total of 71 subjects were randomized, in a 1:1:1 ratio, to receive either placebo, 4 mg elamipretide, or 40 mg elamipretide once daily for 28 consecutive days. Each treatment group went through 3 distinct periods: Screening, Treatment, and Follow up.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	4 mg elamipretide	Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days
DRUG	40 mg elamipretide	Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days
DRUG	Placebo	Subcutaneous injection of placebo administered once daily for 28 consecutive days

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-09-01
• Completion: 2017-10-01
• First posted: 2016-06-02
• Last updated: 2020-05-14
• Results posted: 2020-04-22

Locations

15 sites across 3 countries: Italy, Netherlands, United Kingdom