Recruiting
Phase 2

Elamipetide

Sponsor:

David Marcinek

Code:

NCT07275424

Conditions

Aging, Healthy

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

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)

Study Details

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.

Conditions

Aging, Healthy

Study ID

NCT07275424

Start date

Nov 26, 2025

Status verified date

Dec, 2025

Completion date

Apr 15, 2026

Anticipated

Primary completion date

Mar 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

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 > 10 mg/day morphine equivalents) 9. No known allergies/adverse effects from Fexofenadine 10. Provide documentation of informed consent

Exclusion Criteria:

1. 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
2. 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.
3. Have a history of rhabdomyolysis
4. 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)
5. Are currently enrolled in a clinical study involving an investigational product or non- approved use of a drug or device or concurrently enrolled in any other type of medical research judged to be scientifically or medically incompatible with this study
6. Have participated within the last 30 days of screening visit in a clinical study involving an investigational product.

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Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Safety and tolerability of daily subcutaneous injection of elamipretide

single arm ELAM intervention

Interventions

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)

Primary Study Objective To evaluate the safety and tolerability of daily subcutaneous injections of elamipetide for 4 weeks in adults aged 65-80

Secondary Objective To assess inflammatory biomarker changes with 4-week daily injection of elamipetide on healthy aging To assess the skeletal muscle health in older subjects with lower aerobic capacity (cardiovascular health) To assess cognitive function changes with 4-week SC daily injection of elamipetide

Primary outcome measure

  • To evaluate the safety and tolerability of daily subcutaneous injections of elamipetide: Number of participants with treatment-related adverse events and Number of participants completed 4 weeks of injection [ Time Frame: 4 week ]

Central Contacts and Locations

Central contacts

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

Sophia Liu Lab manager

206-667-5000sophia21@uw.edu

More Information

Sponsor

David Marcinek

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • healthspan
  • healthy aging
  • mobility
  • cognitive function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by David Marcinek on 2025-12-10.