Aging, HealthyPhase 2SHAPENCT07275424
Study of Healthy Aging and Physical Function With Elamipretide
A Phase 2 study testing 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) in people with Aging, Healthy, run by David Marcinek at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Healthy
- What is being tested?
- 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)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2025to 15 Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98109
Sophia Liu Lab manager, 206-667-5000, sophia21@uw.edu
About this study
Official title: Open-Label, Single-Arm Phase 2a Pilot Study to Evaluate the Safety and Tolerability of a Daily Subcutaneous Dose of Elamipretide in Older Adults
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.
Read the detailed description
This study will be a Phase 2a, open-label, single-arm study enrolling older adults subjects with lower function. The primary objective of this study is to evaluate the safety and tolerability of elamipretide, given as daily subcutaneous injection over 4 weeks. Secondary endpoints will test whether the administration of elamipretide results in changes in blood biomarkers of inflammation and improved cognitive and mobility functional performance in an older adult population. This study will be conducted in strict compliance with the protocol, current Good Clinical Practice (GCP) and all Food and Drug Administration (FDA) guidelines.
- Conditions
- Aging, Healthy
- Being tested
- 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)
- Keywords
- healthspan, healthy aging, mobility, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Safety and tolerability of daily subcutaneous injection of elamipretide | Other | single arm ELAM intervention Receives: Drug: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 week
Secondary outcomes (5)
blood inflammation markers
levels of BDNF, VEGF, IGF-1, IL-6
Measured: up to 5 months from first enrollment
blood inflammation marker
level of TNF-a
Measured: up to 5 months from first enrollment
Delta 6 minute walk test
Change in distance walked in 6 minutes following 4 weeks of intervention
Measured: 4-6 weeks after enrollment
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.
Measured: 4-6 weeks after enrollment
Delta skeletal muscle strength
The investigators will measure the change in muscle strength on a 1 rep knee extensor assay following 4 weeks of intervention
Measured: 4-6 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start26 Nov 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Marcinek
- Sponsor type
- University, hospital or other
- Collaborators
- Stealth BioTherapeutics Inc.
- Responsible party
- Sponsor-investigator, David Marcinek, University of Washington
- Investigators
- David Marcinek, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275424
- Sponsor's protocol ID
- STUDY00023162
- Acronym
- SHAPE
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be published and listed on clinical trial.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single-Arm Phase 2a Pilot Study to Evaluate the Safety and Tolerability of a Daily Subcutaneous Dose of Elamipretide in Older Adults
- ClinicalTrials.gov ID
- NCT07275424
- Acronym / sponsor ID
- SHAPE / STUDY00023162
- Conditions
- Aging, Healthy
- Keywords
- healthspan, healthy aging, mobility, cognitive function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- David MarcinekUniversity, hospital or other
- Collaborators
- Stealth BioTherapeutics Inc.
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a Phase 2a, open-label, single-arm study enrolling older adults subjects with lower function. The primary objective of this study is to evaluate the safety and tolerability of elamipretide, given as daily subcutaneous injection over 4 weeks. Secondary endpoints will test whether the administration of elamipretide results in changes in blood biomarkers of inflammation and improved cognitive and mobility functional performance in an older adult population. This study will be conducted in strict compliance with the protocol, current Good Clinical Practice (GCP) and all Food and Drug Administration (FDA) guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety and tolerability of daily subcutaneous injection of elamipretide | Other | Drug: 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)single arm ELAM intervention |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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)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 | Drug | Safety and tolerability of daily subcutaneous injection of elamipretide |
Primary outcome
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
5 secondary outcomes
blood inflammation markers
Time frame: up to 5 months from first enrollment
blood inflammation marker
Time frame: up to 5 months from first enrollment
Delta 6 minute walk test
Time frame: 4-6 weeks after enrollment
Delta cognitive function score
Time frame: 4-6 weeks after enrollment
Delta skeletal muscle strength
Time frame: 4-6 weeks from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Yes. Data will be published and listed on clinical trial.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Marcinek, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 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) in people with Aging, Healthy, run by David Marcinek at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia Liu, PhD (206-543-0209, sophia21@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.