Study of Healthy Aging and Physical Function With Elamipretide (SHAPE)

Open-Label, Single-Arm Phase 2a Pilot Study to Evaluate the Safety and Tolerability of a Daily Subcutaneous Dose of Elamipretide in Older Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Aging, Healthy
• Intervention / Treatment: Drug: 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)

Detailed Description

This study will be a Phase 2a, open-label, single-arm study enrolling older adults subjects with lower function. The primary objective of this study is to evaluate the safety and tolerability of elamipretide, given as daily subcutaneous injection over 4 weeks. Secondary endpoints will test whether the administration of elamipretide results in changes in blood biomarkers of inflammation and improved cognitive and mobility functional performance in an older adult population. This study will be conducted in strict compliance with the protocol, current Good Clinical Practice (GCP) and all Food and Drug Administration (FDA) guidelines.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sophia Liu, PhD; Phone Number: 206-543-0209; Email: sophia21@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • University of Washington
      • Contact: Sophia Liu Lab manager; Phone Number: 206-667-5000; Email: sophia21@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Safety and tolerability of daily subcutaneous injection of elamipretide; single arm ELAM intervention

Drug: 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); Primary Study Objective To evaluate the safety and tolerability of daily subcutaneous injections of elamipetide for 4 weeks in adults aged 65-80 Secondary Objective To assess inflammatory biomarker changes with 4-week daily injection of elamipetide on healthy aging To assess the skeletal muscle health in older subjects with lower aerobic capacity (cardiovascular health) To assess cognitive function changes with 4-week SC daily injection of elamipetide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood inflammation markers	levels of BDNF, VEGF, IGF-1, IL-6	up to 5 months from first enrollment
blood inflammation marker	level of TNF-a	up to 5 months from first enrollment
Delta 6 minute walk test	Change in distance walked in 6 minutes following 4 weeks of intervention	4-6 weeks after enrollment
Delta cognitive function score	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.	4-6 weeks after enrollment
Delta skeletal muscle strength	The investigators will measure the change in muscle strength on a 1 rep knee extensor assay following 4 weeks of intervention	4-6 weeks from enrollment

Collaborators and Investigators

• Sponsor: David Marcinek
• Collaborators: Stealth BioTherapeutics Inc.
• Investigators: Principal Investigator: David Marcinek, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2025
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: October 15, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: cognitive function; mobility; healthy aging; healthspan
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Benzene Derivatives; Alcohols; Benzyl Alcohols; Benzyl Compounds; Benzyl Alcohol; arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide
• Other Study ID Numbers: STUDY00023162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be published and listed on clinical trial.gov

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No