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RECRUITING
NCT07275424
PHASE2

Study of Healthy Aging and Physical Function With Elamipretide

Sponsor: David Marcinek

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-11-26

Completion Date

2026-04-15

Last Updated

2025-12-10

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

University of Washington

Seattle, Washington, United States