Study of Healthy Aging and Physical Function With Elamipretide

What Was Tested

In this phase 2 trial, researchers set out to test SS-31 (Elamipretide).

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.

It had 1 arm (groups): Safety and tolerability of daily subcutaneous injection of elamipretide (other).

Single arm ELAM intervention.

The registry classes the interventions as drug.

More on the Plan

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.

This study will be conducted in strict compliance with the protocol, current Good Clinical Practice (GCP) and all Food and Drug Administration (FDA) guidelines.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to people of any sex aged from 65 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female aged ≥65 and ≤80 years. 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.

The full record lists 12 inclusion and 6 exclusion criteria; among the exclusions: have a history of rhabdomyolysis; have participated within the last 30 days of screening visit in a clinical study involving an investigational product.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when SS-31 (Elamipretide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-11-26 with completion listed for 2026-03-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main 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).

It also tracked 5 secondary outcomes, for example blood inflammation markers, blood inflammation marker, Delta 6 minute walk test, Delta cognitive function score and Delta skeletal muscle strength.

What This Means in Plain Language

Put simply, this is a phase 2 trial of SS-31 (Elamipretide) in 30 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the SS-31 (Elamipretide) compound page, all human trials.