Stealth Biotherapeutics Inc.

🇺🇸United States

Country: 🇺🇸United States

Ownership: -

Employees: -

Market Cap: -

Website

Clinical Trials

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

Phase 2

Completed

Conditions: Chronic Heart Failure

Interventions: Drug: Placebo
Drug: elamipretide

First Posted Date: 2016-06-27

Last Posted Date: 2017-09-07

Lead Sponsor: Stealth BioTherapeutics Inc.

Target Recruit Count: 46

Registration Number: NCT02814097

Locations: 🇷🇸
Clinical Center Niš, Clinic for Cardiology, Niš, Serbia
🇷🇸
Clinical Hospital Center "Dr Dragiša Mišović-Dedinje", Department of Cardiology, Belgrade, Serbia
🇷🇸
Clinical Hospital Center "Bežanijska Kosa", Department of Cardiology, Belgrade, Serbia

and more 6 locations

Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study

Phase 2

Completed

Conditions: Primary Mitochondrial Disease

Interventions: Drug: Elamipretide
Drug: Placebo

First Posted Date: 2016-06-20

Last Posted Date: 2020-07-17

Lead Sponsor: Stealth BioTherapeutics Inc.

Target Recruit Count: 30

Registration Number: NCT02805790

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
University of California, San Diego, California, United States
🇺🇸
Children's Hospital of Pittsburg of UPMC, Pittsburgh, Pennsylvania, United States

and more 1 locations

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

Phase 2

Completed

Conditions: Heart Failure

Interventions: Drug: 4 mg elamipretide
Drug: 40 mg elamipretide
Drug: Placebo

First Posted Date: 2016-06-02

Last Posted Date: 2020-05-14

Lead Sponsor: Stealth BioTherapeutics Inc.

Target Recruit Count: 71

Registration Number: NCT02788747

Locations: 🇮🇹
A.O. Papa Giovanni XXIII Cardiologia 1, Torre 5, Bergamo, Italy
🇮🇹
A.O. Spedali Civili di Brescia Cardiologia, Brescia, Italy
🇳🇱
University Medical Centre Groningen, Groningen, Netherlands

and more 12 locations

A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy

Phase 2

Completed

Conditions: Leber's Hereditary Optic Neuropathy

Interventions: Drug: elamipretide (MTP-131) 1% topical ophthalmic solution
Drug: Vehicle topical ophthalmic solution

First Posted Date: 2016-02-26

Last Posted Date: 2021-11-30

Lead Sponsor: Stealth BioTherapeutics Inc.

Target Recruit Count: 12

Registration Number: NCT02693119

Locations: 🇺🇸
Doheny Eye Center, Pasadena, California, United States

A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)

Phase 1

Completed

Conditions: Fuchs' Corneal Endothelial Dystrophy (FCED)

Interventions: Drug: Part A Placebo
Drug: Part A Elamipretide 1.0% Ophthalmic Solution
Drug: Part B Elamipretide 3.0% Ophthalmic Solution
Drug: Part B Placebo

First Posted Date: 2016-01-12

Last Posted Date: 2021-09-17

Lead Sponsor: Stealth BioTherapeutics Inc.

Target Recruit Count: 22

Registration Number: NCT02653391

Locations: 🇺🇸
Ophthalmic Consultants of Boston, Boston, Massachusetts, United States
🇺🇸
Cincinnati Eye Institute, Edgewood, Kentucky, United States

A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function

Phase 1

Completed

Conditions: Normal and Impaired Renal Function

Interventions: Drug: MTP-131

First Posted Date: 2015-05-06

Last Posted Date: 2015-11-18

Lead Sponsor: Stealth BioTherapeutics Inc.

Target Recruit Count: 23

Registration Number: NCT02436447

A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure

Phase 1

Withdrawn

Conditions: Heart Failure

Interventions: Drug: MTP-131
Drug: Placebo

First Posted Date: 2015-03-17

Last Posted Date: 2015-10-15

Lead Sponsor: Stealth BioTherapeutics Inc.

Registration Number: NCT02388529

A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure

Phase 1

Completed

Conditions: Congestive Heart Failure

Interventions: Drug: MTP-131
Drug: Placebo

First Posted Date: 2015-03-17

Last Posted Date: 2015-09-17

Lead Sponsor: Stealth BioTherapeutics Inc.

Target Recruit Count: 36

Registration Number: NCT02388464

Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy

Phase 1

Completed

Conditions: Mitochondrial Myopathy

Interventions: Drug: elamipretide (low dose)
Drug: elamipretide (intermediate dose)
Drug: elamipretide (high dose)
Drug: Placebo

First Posted Date: 2015-02-20

Last Posted Date: 2019-12-27

Lead Sponsor: Stealth BioTherapeutics Inc.

Target Recruit Count: 36

Registration Number: NCT02367014

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
University of California, San Diego, California, United States
🇺🇸
Children's Hospital of Pittsburg of UPMC, Pittsburgh, Pennsylvania, United States

and more 1 locations

A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration

Phase 1

Completed

Conditions: Age-related Macular Degeneration
Diabetic Macular Edema

Interventions: Drug: MTP-131

First Posted Date: 2014-12-11

Last Posted Date: 2015-10-26

Lead Sponsor: Stealth BioTherapeutics Inc.

Target Recruit Count: 20

Registration Number: NCT02314299

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