Study type: Human research · Status: Verified against declared source

In vivo mitochondrial ATP production is improved in older adult skeletal muscle after a single dose of elamipretide in a randomized trial.

PloS one · 2021

Study scale: Here, we report the results from a randomized, double-blind, placebo controlled clinical trial that evaluated the safety and efficacy of a single dose of ELAM on surrogate endpoints of mitochondrial and muscle function in healthy older adults.

Abstract only: Open source record

Product or molecular entity relationships

SS-31: Exact entity relationship. Legacy citation custody associates this source with the catalog record; no product-relevance conclusion is implied.

Plain-language verified summary

Question

Not reported in the reviewed source.

Methods

In a double-blind placebo-controlled randomized clinical trial a single 2-hour infusion of ELAM improves in vivo ATPmax in the FDI over placebo in skeletal muscle of older adults.

Scale or participants

Here, we report the results from a randomized, double-blind, placebo controlled clinical trial that evaluated the safety and efficacy of a single dose of ELAM on surrogate endpoints of mitochondrial and muscle function in healthy older adults.

Key findings

A single ELAM dose elevated mitochondrial energetic capacity in vivo relative to placebo (ΔATPmax; P = 0.055, %ΔATPmax; P = 0.045) immediately after a 2-hour infusion.

Limitations and uncertainty

Elamipretide (ELAM, also referred to as SS-31 and Bendavia in the literature) is a first-in-class compound that binds reversibly to the phospholipid cardiolipin (CL) located within the inner mitochondrial membrane to stabilize its structure, promote cristae formation and curvature, and positively alter the electrostatic environment.

Verified against declared source. Verification is limited to the declared source and review scope. It does not mean independent replication or establish efficacy, safety, or suitability.