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Study of Healthy Aging and Physical Function With Elamipretide

NCT07275424 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    collaborator INDUSTRY

  • David Marcinek

    lead OTHER

Principal Investigators

  • David Marcinek, PhD · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-26
Primary Completion
2026-03-15
Completion
2026-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07275424 on ClinicalTrials.gov