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New treatment option for Aging, Healthy
Official title Study of Healthy Aging and Physical Function With Elamipretide
ClinicalTrials.gov ID: NCT07275424
What this study is testing
What is 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)?
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) is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for aging, healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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
- Willing and able to self-administer injections or have a willing caregiver who is able to administer injections.
You likely can't join if
- 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...
- Presence of severe renal disease (eGFR \ 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...
- Are currently enrolled in a clinical study involving an investigational product or non- approved use of a drug or device or concurrently enrolled in...
- Have participated within the last 30 days of screening visit in a clinical study involving an investigational product. \-
See the full eligibility criteria
- 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
- Willing and able to self-administer injections or have a willing caregiver who is able to administer injections.
- Speak and read English
- Have no established daily exercise routine and are not participating in any exercise training program or physical hobby (i.e. dance, martial arts, yoga) and agree to not start any such activities during the course of...
- Willing to avoid the following medications during the course of the study: Anti-seizure medications
- Coenzyme Q10, creatine, L-carnitine, and other supplements intended to increase muscle mass, energy or function
- Muscle relaxants
- Systemic steroid or immunosuppressive use
- Opioids (regular use of \> 10 mg/day morphine equivalents) 9. No known allergies/adverse effects from Fexofenadine 10. Provide documentation of informed consent
- 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...
- Presence of severe renal disease (eGFR \ 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...
- Are currently enrolled in a clinical study involving an investigational product or non- approved use of a drug or device or concurrently enrolled in any other type of medical research judged to be scientifically or...
- Have participated within the last 30 days of screening visit in a clinical study involving an investigational product. \-
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.