NCT02814097

A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Stealth BioTherapeutics Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4 weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.

Conditions

• Chronic Heart Failure

Interventions

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

Timeline

• Start date: 2016-09-02
• Primary completion: 2017-05-04
• Completion: 2017-06-02
• First posted: 2016-06-27
• Last updated: 2017-09-07

Locations

9 sites across 2 countries: Germany, Serbia