Elamipretide for Aging

(SHAPE Trial)

Overseen By Sophia Liu, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: David Marcinek

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

David Marcinek, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for healthy older adults interested in improving physical function. Participants must be willing to receive daily injections of Elamipretide for 4 weeks and attend follow-up visits. Specific eligibility criteria are not provided, but typically include age range and health status requirements.

Inclusion Criteria

I can give myself injections or have someone who can do it for me.

Speak and read English

I am between 65 and 80 years old.

Exclusion Criteria

I do not have severe kidney or liver disease.

I have had rhabdomyolysis before.

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)

What Are the Treatments Tested in This Trial?

Interventions

• Elamipretide

Trial Overview The study tests the effects of a daily dose of Elamipretide on aging and physical function over a period of 4 weeks. It includes baseline assessments, a midpoint check-in, and post-intervention evaluations to compare changes in participants' physical abilities.

How Is the Trial Designed?

Group I: Safety and tolerability of daily subcutaneous injection of elamipretide Experimental Treatment 1 Intervention

single arm ELAM intervention

Who Is Running the Clinical Trial?

David Marcinek

Lead Sponsor

Stealth BioTherapeutics Inc.

Industry Sponsor

Trials

29

Recruited

2,300+