Study of Healthy Aging and Physical Function With Elamipretide

NCT07275424 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY00023162
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

healthspan; healthy aging; mobility; cognitive function

Outcome Measures

Primary Outcomes (1)

• 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

  4 week

Secondary Outcomes (5)

• blood inflammation markers

  up to 5 months from first enrollment

• blood inflammation marker

  up to 5 months from first enrollment

• Delta 6 minute walk test

  4-6 weeks after enrollment

• Delta cognitive function score

  4-6 weeks after enrollment

• Delta skeletal muscle strength

  4-6 weeks from enrollment

Study Arms (1)

Safety and tolerability of daily subcutaneous injection of elamipretide

OTHER

single arm ELAM intervention

Drug: 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)

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) DRUG

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

Safety and tolerability of daily subcutaneous injection of elamipretide

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• Willing and able to self-administer injections or have a willing caregiver who is able to administer injections.
• Speak and read English
• 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
• 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

You may not qualify if:

• 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)
• 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
• Have participated within the last 30 days of screening visit in a clinical study involving an investigational product.

Sponsors & Collaborators

• David Marcinek: lead
• Stealth BioTherapeutics Inc.: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Interventions

arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide; Benzyl Alcohol

Intervention Hierarchy (Ancestors)

Benzyl Alcohols; Alcohols; Organic Chemicals; Benzyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• David Marcinek, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Liu, PhD

CONTACT

206-543-0209; sophia21@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: December 10, 2025
• Study Start: November 26, 2025
• Primary Completion: March 15, 2026
• Study Completion: April 15, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)