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MMPOWER-3 Protocol Update

MMPOWER-3 Protocol Update


MMPOWER-3 Trial

MMPOWER-3 is a phase 3, randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of daily sucutaneous (under the skin) injections of elemipretide in patients with primary mitochondrial myopathy (PMM) follwed by an open-label extension.


Eiigibility *

  • Have previous genetic testing results available.

  •  Able to walk.

  • Between 16 years to 80 years of age.

  • Diagnosed with PMM in the opinion of the investigator.

    *Other eligibility criteria applied

Trial Enrollment

  • The trial will assess approximately 200 patients, aged 16-80, across North America and Europe. Visit Clinicaltrials.gov for a list of trial sites.

Click here for a complete list of sites and contacts.


Frequently Asked Questions About MMPOWER-3


What will MMPOWER-3 study?

  • MMPOWER-3 is a phase 3, randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of daily subcutaneous (under the skin) injections of elamipretide in patients with PMM followed by an open-label treatment extension.

  • The trial will primarily assess the change in distance walked during the six-minute walk test (6MWT) and patient-reported fatigue using a PMM-specific questionnaire, the Primary Mitochondrial Myopathy Symptom Assessment (PMMSA). Secondarily, the trial will evaluate changes in fatigue during activities using the PMMSA, quality of life, impact on the patient’s most bothersome symptom on the PMMSA, and safety and tolerability of treatment with elamipretide.

What is the drug being studied, and how does it work?

  • In MMPOWER-3, Stealth is evaluating elamipretide delivered by subcutaneous (under the skin) injection. Elamipretide is an investigational drug that associates with cardiolipin, a key structural component of the inner mitochondrial membrane, and has shown to improve mitochondrial function in preclinical and early clinical studies. 

How will investigators select patients to participate in the MMPOWER-3 trial?

  • Patients that have a genetic confirmation of mitochondrial disease are potentially eligible for participation in MMPOWER-3. The clinical trial investigator will identify potential patients.

How long does MMPOWER-3 last?

  • Subjects enrolled in the trial will receive daily injections of elamipretide or placebo for six months. At the end of the six-month period, subjects may elect to participate in the open-label treatment extension and will receive elamipretide for the duration of the trial.