NCT02814097 is a Phase 2 clinical trial of elamipretide in Chronic Heart Failure, sponsored by Stealth BioTherapeutics Inc..

Who is sponsoring NCT02814097?

NCT02814097 is sponsored by Stealth BioTherapeutics Inc..

What drugs are being tested in NCT02814097?

Interventions in NCT02814097: elamipretide, Placebo.

What condition does NCT02814097 study?

NCT02814097 studies Chronic Heart Failure.

Is NCT02814097 still recruiting?

NCT02814097 is currently completed. Last updated 7 September 2017.

Last reviewed 2017-09-07 · How we verify

NCT02814097

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 7 September 2017

What this trial tests

Phase 2 trial testing elamipretide in Chronic Heart Failure in 46 participants. Completed in 2 June 2017.

Timeline

2 September 2016

Primary endpoint
4 May 2017

2 June 2017

Quick facts

Lead sponsor	Stealth BioTherapeutics Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	46
Start date	2 September 2016
Primary completion	4 May 2017
Estimated completion	2 June 2017
Sites	9 locations across Serbia, Germany

Drugs / interventions tested

elamipretide (ELAMIPRETIDE) — full drug profile →
Placebo

Conditions studied

Chronic Heart Failure — all drugs for Chronic Heart Failure →

Sponsor

Stealth BioTherapeutics Inc. — full company profile →

Who can join

Adults 40 to 80, any sex, with Chronic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Impact of Oxidative Stress on the Heart and Vasculature: Part 2 of a 3-Part Series.
Münzel T, Camici GG, Maack C, Bonetti NR, et al · · 2017 · cited 427× · PMID 28683969 · DOI 10.1016/j.jacc.2017.05.035
Sources of Vascular Nitric Oxide and Reactive Oxygen Species and Their Regulation
Tejero J, Shiva S, Gladwin MT. · · 2019 · cited 357× · PMID 30379623 · DOI 10.1152/physrev.00036.2017
Mitochondrial Dysfunction in Heart Failure With Preserved Ejection Fraction.
Kumar AA, Kelly DP, Chirinos JA. · · 2019 · cited 228× · PMID 30856000 · DOI 10.1161/circulationaha.118.036259
Mitochondrial ROS Drive Sudden Cardiac Death and Chronic Proteome Remodeling in Heart Failure.
Dey S, DeMazumder D, Sidor A, Foster DB, et al · · 2018 · cited 205× · PMID 29898892 · DOI 10.1161/circresaha.118.312708
Oxidative Stress and New Pathogenetic Mechanisms in Endothelial Dysfunction: Potential Diagnostic Biomarkers and Therapeutic Targets.
Scioli MG, Storti G, D'Amico F, Rodríguez Guzmán R, et al · · 2020 · cited 178× · PMID 32630452 · DOI 10.3390/jcm9061995
Targeting mitochondrial dysfunction and oxidative stress in heart failure: Challenges and opportunities.
Kiyuna LA, Albuquerque RPE, Chen CH, Mochly-Rosen D, et al · · 2018 · cited 160× · PMID 30227272 · DOI 10.1016/j.freeradbiomed.2018.09.019
Mitochondria-Targeted Antioxidants: A Step towards Disease Treatment.
Jiang Q, Yin J, Chen J, Ma X, et al · · 2020 · cited 123× · PMID 33354280 · DOI 10.1155/2020/8837893
Targeting the Mitochondria in Heart Failure: A Translational Perspective.
Sabbah HN. · · 2020 · cited 98× · PMID 32043022 · DOI 10.1016/j.jacbts.2019.07.009

Verify or expand the search:

Other trials of elamipretide

Trials testing the same drug.

NCT03323749 — A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension · Phase 3 · terminated
NCT02914665 — A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospital · Phase 2 · completed
NCT04689360 — An Intermediate Size Expanded Access Protocol of Elamipretide · available

Other recruiting trials for Chronic Heart Failure

Currently open trials in the same condition.

NCT07265349 — A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure · Phase 1, PHASE2 · recruiting
NCT07379840 — A Study to Learn More About How Safe Finerenone is and How Well it Works in Adults With Chronic Heart Failure in South K · recruiting
NCT07325942 — Effectiveness of Low -Versus High -Volume High -Intensity Interval Training in Patients With Chronic Heart Failure · NA · recruiting
NCT07434193 — Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergo · NA · recruiting
NCT07405944 — Vericiguat and Reverse Remodeling Indices in Heart Failure · Phase 4 · recruiting

Other Stealth BioTherapeutics Inc. trials

Trials by the same sponsor.

NCT07531251 — Ph3b/4 Trial in Patients With Barth Syndrome · Phase 4 · not yet recruiting
NCT05162768 — Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mu · Phase 3 · completed
NCT03891875 — ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA · Phase 2 · completed
NCT03323749 — A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension · Phase 3 · terminated
NCT03098797 — A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome · Phase 2, PHASE3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02814097 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stealth BioTherapeutics Inc.
Last refreshed: 7 September 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02814097.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing