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Trial · Interventional

RecruitingPhase 2Registry data

Study of Healthy Aging and Physical Function With Elamipretide

Short name SHAPE

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
30 participants (estimated)
Sponsor
David Marcinek · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
26 Nov 2025
Primary completion
15 Mar 2026 (estimated)
Completion
15 Apr 2026 (estimated)
First posted
10 Dec 2025
Last update posted
10 Dec 2025
Conditions
Aging, Healthy

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 2

    SHAPE

    NCT07275424

    26 Nov 2025 to est. 15 Apr 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • 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

Arms1

  • Other

    Safety and tolerability of daily subcutaneous injection of elamipretide

    single arm ELAM intervention

Primary outcomes1

Outcomes the sponsor listed as primary.

  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(5)
  1. blood inflammation markers

    Time frame · up to 5 months from first enrollment

    Registry description

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

  2. blood inflammation marker

    Time frame · up to 5 months from first enrollment

    Registry description

    level of TNF-a

  3. Delta 6 minute walk test

    Time frame · 4-6 weeks after enrollment

    Registry description

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

  4. Delta cognitive function score

    Time frame · 4-6 weeks after enrollment

    Registry description

    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.

  5. Delta skeletal muscle strength

    Time frame · 4-6 weeks from enrollment

    Registry description

    The investigators will measure the change in muscle strength on a 1 rep knee extensor assay following 4 weeks of intervention

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 65 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Male or female aged ≥65 and ≤80 years 2. VO2peak ≤ 37.3ml/kg/min for men and ≤ 25.7ml/kg/min for women as evidence of lower mitochondrial function 3. Are ambulatory and able to perform activities of daily living without assistance 4. Have sufficient venous access for clinical blood draw 5. Willing and able to self-administer injections or have a willing caregiver who is able to administer injections. 6. Speak and read English 7. 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 8. 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: 1. 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 2. 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. 3. Have a history of rhabdomyolysis 4. 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) 5. 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 6. Have participated within the last 30 days of screening visit in a clinical study involving an investigational product. \-

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