NCT07275424

Study of Healthy Aging and Physical Function With Elamipretide

Open-Label, Single-Arm Phase 2a Pilot Study to Evaluate the Safety and Tolerability of a Daily Subcutaneous Dose of Elamipretide in Older Adults

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: David Marcinek · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will be a Phase 2a, open-label, single-arm study enrolling older adults subjects with lower function. The primary objective of this study is to evaluate the safety and tolerability of elamipretide, given as daily subcutaneous injection over 4 weeks. Secondary endpoints will test whether the administration of elamipretide results in changes in blood biomarkers of inflammation and improved cognitive and mobility functional performance in an older adult population. This study will be conducted in strict compliance with the protocol, current Good Clinical Practice (GCP) and all Food and Drug Administration (FDA) guidelines.

Conditions

• Aging, Healthy

Interventions

Type	Name	Description
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)	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

Timeline

• Start date: 2025-11-26
• Primary completion: 2026-03-15
• Completion: 2026-04-15
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study