Elamipretide for Aging

(SHAPE Trial)

Overseen By Sophia Liu, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: David Marcinek

Must not be taking: Anti-seizure, Muscle relaxants, Opioids, others

Disqualifiers: Severe renal, Hepatic disease, Rhabdomyolysis, others

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: 2

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called elamipretide, a mitochondrial-targeting drug, to determine if it can enhance the health of older adults by boosting mitochondrial function, crucial for energy production. Participants will receive a daily injection for four weeks, with regular check-ins and follow-ups to monitor safety and tolerability. The trial seeks adults aged 65 to 80 who can walk and perform daily activities independently but do not follow an exercise routine. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications for the trial?

You will need to stop taking certain medications and supplements during the study, including anti-seizure medications, Coenzyme Q10, creatine, L-carnitine, muscle relaxants, systemic steroids, immunosuppressants, and regular opioid use over 10 mg/day. The protocol does not specify other medications, so check with the study team about any other medications you are taking.

Is there any evidence suggesting that elamipretide is likely to be safe for humans?

Research has shown that elamipretide is generally safe and well-tolerated. In a study on age-related macular degeneration (AMD), patients found it safe, with no major side effects reported. Another study examined its use for healthy aging and found that a daily injection for four weeks was well-tolerated by older adults, indicating it is manageable for most people. The ongoing trial will provide more specific safety data. However, based on past research, elamipretide appears to have a good safety profile so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Elamipretide is unique because it targets the mitochondria, the powerhouse of the cell, to improve their function, potentially slowing down the effects of aging. Unlike other treatments that might be more general in their approach, elamipretide specifically works to repair and protect these vital cell components. Additionally, it's administered through a daily subcutaneous injection, which allows it to directly enter the bloodstream and reach the cells efficiently. Researchers are excited about this treatment because it offers a novel way to enhance cellular energy and resilience, which could lead to significant improvements in age-related conditions.

What evidence suggests that elamipretide could be an effective treatment for aging?

Research shows that elamipretide (SS-31), the investigational treatment in this trial, may combat the effects of aging. Studies have found that it can enhance heart health in older mice by improving heart function. Elamipretide improves mitochondrial function, the cell components responsible for energy production. This mitochondrial boost can help reverse some age-related health declines. Other research suggests that elamipretide might also aid in addressing age-related vision problems. These early findings support its potential in tackling aging concerns. ^{2 6 7 8 9}

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Baseline measurements are taken before the intervention period begins

1 week

Treatment

Participants receive a daily subcutaneous dose of elamipretide for 4 weeks

4 weeks

Midpoint check-in phone interview at 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Post-intervention visits that mirror baseline visits

Extended Monitoring

Monitoring of secondary outcomes such as blood inflammation markers up to 5 months from first enrollment

up to 5 months

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9562127/

Long-term treatment with Elamipretide enhances healthy ...

Elam enhanced healthy aging and cardiac function in both male and female mice, although the specific effects on function differed between sexes.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1567724924000047

Application research of novel peptide mitochondrial ...

Elamipretide (SS-31), a novel synthetic mitochondrial-targeted antioxidant, has emerged as a promising candidate with extensive therapeutic potential.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8599536/

Elamipretide (SS-31) treatment attenuates age-associated ...

It has been demonstrated that elamipretide (SS-31) rescues age-related functional deficits in the heart but the full set of mechanisms behind this have yet ...

4.

journals.biologists.com

journals.biologists.com/dmm/article/15/3/dmm048256/274438/Treatment-of-age-related-visual-impairment-with-a

Treatment of age-related visual impairment with a peptide ...

These data indicate that elamipretide treatment adaptively alters the aging visual system. They also provide a rationale to investigate ...

5.

elifesciences.org

elifesciences.org/articles/55513

Late-life restoration of mitochondrial function reverses ...

We show here that 8-week treatment of old mice with the mitochondrial targeted peptide SS-31 (elamipretide) can substantially reverse this deficit.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07275424

Study of Healthy Aging and Physical Function With ...

The primary objective of this study is to evaluate the safety and tolerability of elamipretide, given as daily subcutaneous injection over 4 ...

7.

ophthalmologyscience.org

ophthalmologyscience.org/article/S2666-9145(24)00164-7/fulltext

ReCLAIM-2: A Randomized Phase II Clinical Trial ...

This study evaluated the safety and efficacy of elamipretide in dry age-related macular degeneration (AMD) with noncentral geographic atrophy ( ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666914521000907

Phase 1 Clinical Trial of Elamipretide in Intermediate Age ...

Elamipretide appeared to be generally safe and well tolerated in treating intermediate AMD and HRD. Exploratory analyses demonstrate a positive effect on ...

9.

sites.uw.edu

sites.uw.edu/marcinek/2025/10/15/shape-study-of-healthy-aging-and-physical-function-with-elamipretide/

(SHAPE) Study of Healthy Aging and Physical Function with ...

The goal of this study is to establish the safety and tolerability of 4-weeks of daily subcutaneous injections in older adult and explore ...