Study of Healthy Aging and Physical Function With Elamipretide
ConditionAging, Healthy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-80
SponsorDavid Marcinek
About this trial
This study will utilize a daily dose of elamipetide for 4 weeks and will screen a sufficient number of subjects for 30 subjects to enroll in the study. The planned duration of the study includes baseline measurement, followed by 4 weeks intervention period, a midpoint (2week ±3days) check-in phone interview, and post intervention visits that mirror the baseline visits. After the last injection, subjects will enter the 2-week follow-up period, concluded by the end-of-study contact.
Eligibility criteria
Qualifiers
Male or female aged ≥65 and ≤80 years
VO2peak ≤ 37.3ml/kg/min for men and ≤ 25.7ml/kg/min for women as evidence of lower mitochondrial function
Are ambulatory and able to perform activities of daily living without assistance
Have sufficient venous access for clinical blood draw
Disqualifiers
Have significant disease(s) or condition(s) which, in the opinion of the investigator, may put the subject at risk because of their participation in the study or may influence either the results of the study or the subject's ability to participate in the study
Presence of severe renal disease (eGFR <30 mL/min) or hepatic disease (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2x the upper limit of normal) as evidenced by laboratory results at Screening.
Have a history of rhabdomyolysis
Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g., myocardial infarction, target-vessel revascularization, coronary bypass surgery or stroke) or other major medical condition (as deemed by the primary investigator)
Trial design
Treatments tested in this trial
- Elamipretide will be supplied as a sterile 5.0 mL single-patient, multi-dose glass vial containing 3.75 mL of elamipretide solution (elamipretide [80 mg/mL], phosphate buffer, and benzyl alcohol)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
David Marcinek
Lead sponsor
University of Washington
Sponsor institution
Stealth BioTherapeutics Inc.
Collaborator
Source ClinicalTrials.gov