NCT07275424 Study of Healthy Aging and Physical Function With Elamipretide
| NCT ID | NCT07275424 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | David Marcinek |
| Condition | Aging, Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-11-26 |
| Primary Completion | 2026-03-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Inclusion Criteria: 1. Male or female aged ≥65 and ≤80 years 2. VO2peak ≤ 37.3ml/kg/min for men and ≤ 25.7ml/kg/min for women as evidence of lower mitochondrial function 3. Are ambulatory and able to perform activities of daily living without assistance 4. Have sufficient venous access for clinical blood draw 5. Willing and able to self-administer injections or have a willing caregiver who is able to administer injections. 6. Speak and read English 7. Have no established daily exercise routine and are not participating in any exercise training program or physical hobby (i.e. dance, martial arts, yoga) and agree to not start any such activities during the course of study participation 8. Willing to avoid the following medications during the course of the study: Anti-seizure medications * Coenzyme Q10, creatine, L-carnitine, and other supplements intended to increase muscle mass, energy or function * Muscle relaxants * Systemic steroid or immunosuppressive use * Opioids (regular use of \