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Study of Healthy Aging and Physical function with Elamipretide (SHAPE)

Study of Healthy Aging and Physical function with Elamipretide (SHAPE)

The purpose of the study is to better understand the effects and potential benefits of elamipretide on skeletal muscle and cognitive function in older adults. Elamipretide, the study drug, has FDA accelerated approval as Forzinity™ only for use in the treatment of patients with Barth syndrome in the US weighing ≥ 30 kg

The study involves:
– Self daily injections for four weeks. You will receive training from study medical stuff
– Four in person study visits at FHCC over 8-10 weeks. Study visits are one-two hours long.
– Two follow-up phone calls from the study team.

The study will measure changes in cognitive function, mobility and muscle strength, and blood markers of health.

Study visits are held at the Fred Hutch Cancer Center’s Prevention Center (FHCC). located at Level E of the Robert M, Arnold Building.

Participants will receive $400 at the end of the study.

Participant Eligibility

  • People aged 65-80 who are able to perform daily activities without assistance.
  • Not participating in regular strenuous exercise training 2 or more times per week.
  • Anyone taking supplements intended to increase muscle mass, energy or function, such as coenzyme Q10, creatine, or L-carnitine should be willing to stop taking them while they are on the study.

Contact

J.B. Ingram
206-387-7547

Additional Study Details

Full Study 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

Study ID: 20253531
Start Date: 10/31/2025
End Date: 10/23/2026

Investigator(s)
David Marcinek, PhD
Suman Jayadev, MD

Accepts Healthy Volunteers?
Yes

Study Site(s)

Fred Hutchinson Cancer Center Prevention Center

1100 Fairview Avenue N Level E of the Robert M, Arnold Building
Seattle, Washington 98109



Interested?

Use the link below to send a message to the study coordinator, or call the number above to speak directly with a study representative.

I am interested in this research study.

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