Study of Healthy Aging and Physical Function With Elamipretide
David Marcinek · with Stealth BioTherapeutics Inc. · NCT07275424
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 65–80 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 2
- Target enrollment
- 30
- US sites recruiting
- 1
- Study start
- November 26, 2025
- Record last updated
- December 10, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: 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)
Conditions: Aging, Healthy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion 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 study participation
- 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
Exclusion Criteria
- 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)
- 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 medically incompatible with this study
- Have participated within the last 30 days of screening visit in a clinical study involving an investigational product.
-
Recruiting US locations
University of Washington
Seattle, WA 98109
Site contact: Sophia Liu Lab manager · 206-667-5000 · sophia21@uw.edu
Study contacts (from the official record)
- Sophia Liu, PhD · 206-543-0209 · sophia21@uw.edu
Similar studies in Washington
All healthy volunteers studies in Washington →- RecruitingHealthy volunteersPhase 1/Phase 2
Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
Sanofi
- Location
- Seattle, WA + 49 other US sites
- Eligibility basics
- Ages 60+
- RecruitingHealthy volunteersPhase 1/Phase 2
A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults
GlaxoSmithKline
- Location
- Seattle, WA + 2 other US sites
- Eligibility basics
- Ages 18–80
- RecruitingHealthy volunteersPhase 1/Phase 2
A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age
GlaxoSmithKline
- Location
- Seattle, WA + 5 other US sites
- Eligibility basics
- Ages 18–64
- RecruitingHealthy volunteersPhase 1/Phase 2
Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
Vega Therapeutics, Inc
- Location
- Seattle, WA + 9 other US sites
- Eligibility basics
- Ages 12–60