DRUG
elamipretide
Subcutaneous injection of 40 mg elamipretide once daily for 28 consecutive days
Status
Completed
Phase
Phase 2
Enrollment
46
Locations
9
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Subcutaneous injection of 40 mg elamipretide once daily for 28 consecutive days
DRUG
Subcutaneous injection of placebo administered once daily for 28 consecutive days
Timeline
First posted
Jun 27, 2016
Study start
Sep 2, 2016
Primary completion
May 4, 2017
Study completion
Jun 2, 2017
Results posted
Not reported
Registry updated
Sep 7, 2017
Outcomes
Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups
Time frame · 4 weeks
Compare the change at rest and during submaximal stress in LV systolic global longitudinal strain (GLS) between the elamipretide and placebo groups at the end of the 4-week treatment period
Time frame · 4 weeks
Compare the change in 6-minute walking distance, between the elamipretide and placebo groups at the end of the 4-week treatment period
Time frame · 4 weeks
Compare the change in NT-proBNP, between the elamipretide and placebo groups at the end of the 4-week treatment period
Time frame · 4 weeks
Compare the percent of patients on elamipretide versus placebo presenting with TEAEs and SAEs, including changes in biomarkers of myocardial damage and changes in markers of renal function
Time frame · 4 weeks
Eligibility
Inclusion Criteria: * Age ≥45 and \<80 years. * Symptomatic heart failure (i.e. NYHA II or III) due to HFpEF for at least 6 months prior to study start * Evidence of HFpEF: LVEF ≥45% and E/e´\>10 and NT-pro-BNP \>220 pg/ml (sinus rhythm) / \> 600 pg/mL (atrial fibrillation) * An exercise-induced increase in E/e' of at least 1.5 units during stress echocardiography assessment. * Heart failure is considered to be stable, in the judgment of the investigator, and no hospitalization for HFpEF or changes in dose regimen of pharmacologic treatment for HF has occurred within 1 month prior to the Screening Visit. * Treatment with appropriate pharmacologic therapy to manage underlying risk factors according to current guidelines. * Women of childbearing potential must agree to use 1 of the following methods of birth control from the date they sign the ICF until two months after the last dose of study medication: a) Abstinence, b) surgically sterilized male partner, or c) barrier method And hormonal contraception * Women of child-bearing potential must have a negative serum pregnancy test at baseline * Willing and able to provide signed informed consent form (ICF) prior to participation in any study-related procedures Exclusion Criteria: * Probable alternative diagnoses that in the opinion of the investigator could account for the patient's symptoms e.g. severe pulmonary dysfunction or severe asthma * LVEF \<45% (at the moment of enrollment or in medical history) * Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit. * Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit. * Uncontrolled hypertension defined as a systolic blood pressure (BP) \>160 mm Hg or a diastolic BP \>100 mm Hg on at least 2 consecutive readings that will require a change in anti-hypertensive treatment during the study period. * Active cancer or undergoing chemotherapy within previous 6 months * Total bilirubin \>2x the upper limit of normal (ULN) in the absence of Gilbert's Syndrome (M. Meulengracht) and liver enzymes (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] and/or alkaline phosphatase) elevation \>3xULN * Estimated glomerular filtration rate \<30 mL/min, by MDRD * Known active drug or alcohol abuse within 1 year of the Screening Visit. * Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment * Treatment with spironolactone or eplerenone for less than 3 months at study start * Treatment with dabigatran * Treatment with valsartan/sacubitril * Female subjects who are pregnant, planning to become pregnant, or lactating.
Study locations
Germany · Serbia. Showing up to 24 locations stored in the fast local snapshot.
Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum
Berlin, Germany
German Heart Center
Berlin, Germany
Clinical Centre of Serbia, Clinic for Cardiology
Belgrade, Serbia
Clinical Hospital Center "Dr Dragiša Mišović-Dedinje", Department of Cardiology
Belgrade, Serbia
Clinical Hospital Center "Zvezdara", Department of Cardiology
Belgrade, Serbia
Clinical Hospital Center "Bežanijska Kosa", Department of Cardiology
Belgrade, Serbia
Clinical Hospital Center "Zemun", Department of Cardiology
Belgrade, Serbia
Institute for Cardiovascular Diseases Vojvodina, Clinic for Cardiology
Kamenitz, Serbia
Clinical Center Niš, Clinic for Cardiology
Niš, Serbia
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Stealth BioTherapeutics Inc. · Barth Syndrome
Phase 4
Recruiting
48
2026-07
Stealth BioTherapeutics Inc. · Age Related Macular Degeneration (ARMD)
Phase 3
Active, not recruiting
313
2026-05
Children's Hospital of Philadelphia · Friedreich Ataxia
Phase 1 / Phase 2
Completed
20
2025-12
David Marcinek · Aging, Healthy
Phase 2
Recruiting
30
2025-12
Stealth BioTherapeutics Inc. · Mitochondrial Myopathies · Mitochondrial Pathology
Phase 3
Completed
102
2025-10
Stealth BioTherapeutics Inc. · Mitochondrial Diseases · Barth Syndrome
Not applicable
Available
—
2025-02
Stealth BioTherapeutics Inc. · Age-related Macular Degeneration
Phase 2
Completed
176
2024-07
Stealth BioTherapeutics Inc. · Barth Syndrome
Phase 2 / Phase 3
Completed
12
2024-04
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.