Completed
NA
INTERVENTIONAL
NCT03283462
Bioenergetics and Muscle Function Improvement With AMAZ-02 in Elderly Skeletal Muscle (ENERGIZE Trial)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This is a randomized, double-blind, single-center, placebo-controlled Phase 2 trial enrolling 66 healthy elderly subjects (33 placebo and 33 AMAZ-02 administration) who are ≥65 and ≤ 90 years of age with evidence of low mitochondrial function. AMAZ-02 or placebo will be orally administered for 4 months.
Interventions
Name:
Mitopure
Type:
DIETARY_SUPPLEMENT
Description:
Mitopure (Urolithin A) containing softgels
Name:
Placebo
Type:
DIETARY_SUPPLEMENT
Description:
Placebo containing softgels
Primary Outcomes
Measure:
Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline
TimeFrame:
4 months
Description:
Measure:
Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy)
TimeFrame:
2, 4 months
Description:
Trial Information
NCT ID
NCT03283462
Status
Completed
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Amazentis SA
Last Updated
December 15, 2025