Trial · Interventional
RecruitingPhase 2Registry dataStudy 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
- Ph 2
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.
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)
blood inflammation markers
Time frame · up to 5 months from first enrollment
Registry description
levels of BDNF, VEGF, IGF-1, IL-6
blood inflammation marker
Time frame · up to 5 months from first enrollment
Registry description
level of TNF-a
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
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.
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
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