Study of Healthy Aging and Physical Function With Elamipretide

Part of paid clinical trials in Seattle, Washington.

Sponsor
David Marcinek
Study ID
NCT07275424
Phase
PHASE2
Status
Recruiting
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Conditions

  • Aging, Healthy

Eligibility Criteria

Sex
ALL
Age
65 Years - 80 Years
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) — 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

Study Details

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.

Key Dates

Start date
Nov 26, 2025
Status verified
Dec 2025
Primary completion
Mar 15, 2026
Completion
Apr 15, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Safety and tolerability of daily subcutaneous injection of elamipretide
    single arm ELAM intervention

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98109
Sophia Liu Lab manager
[email protected]
206-667-5000

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By research site
University of Washington· Seattle, WA

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