Health TrialsbyHealthPanel

Study of Healthy Aging and Physical Function With Elamipretide

ConditionAging, Healthy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-80
SponsorDavid Marcinek

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female aged ≥65 and ≤80 years

VO2peak ≤ 37.3ml/kg/min for men and ≤ 25.7ml/kg/min for women as evidence of lower mitochondrial function

Are ambulatory and able to perform activities of daily living without assistance

Have sufficient venous access for clinical blood draw

Disqualifiers

Have significant disease(s) or condition(s) which, in the opinion of the investigator, may put the subject at risk because of their participation in the study or may influence either the results of the study or the subject's ability to participate in the study

Presence of severe renal disease (eGFR <30 mL/min) or hepatic disease (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2x the upper limit of normal) as evidenced by laboratory results at Screening.

Have a history of rhabdomyolysis

Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g., myocardial infarction, target-vessel revascularization, coronary bypass surgery or stroke) or other major medical condition (as deemed by the primary investigator)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Safety and tolerability of daily subcutaneous injection of elamipretideOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

blood inflammation markers

levels of BDNF, VEGF, IGF-1, IL-6

Time frame
up to 5 months from first enrollment
2

blood inflammation marker

level of TNF-a

Time frame
up to 5 months from first enrollment
3

Delta 6 minute walk test

Change in distance walked in 6 minutes following 4 weeks of intervention

Time frame
4-6 weeks after enrollment
4

Delta cognitive function score

MoCA to access cognitive function from different domains. MoCA scale is 0-30 with scores \>26 indicating normal cognitive function. This is measured by a scale the higher means better function. Trail marking A\&B time faster is better; Stroop timed test for attention, processing speed, and executive control.

Time frame
4-6 weeks after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Marcinek

Lead sponsor

University of Washington

Sponsor institution

Stealth BioTherapeutics Inc.

Collaborator

Source ClinicalTrials.gov
Apply now