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Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing Setting

Name: Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing Setting — clinical trial record (NCT07542314)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: ENHANCE

StatusNot Yet Recruiting

PhasePhase 4

SponsorSarepta Therapeutics, Inc.

Started2026-08-31

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary completion moved at least 5 months later Mar 31, 2027 → Aug 31, 2027

See other at-risk trials from Sarepta Therapeutics, Inc.

Amendment history

2026-08-26

Study Status, Contacts/Locations v2

Primary completion pushed: 2027-03-31 → 2027-08-31

Completion pushed: 2027-03-31 → 2027-08-31

Start date2026-07-31→2026-08-31

Study sites0→1

2026-05-22

Study Status v1

Start date2026-04-30→2026-07-31

2026-04-14

Original filing

Sarepta Therapeutics, Inc.

14 trials monitored

See 3 trials at risk

Duchenne Muscular Dystrophy

156 trials monitored

See 6 trials at risk

The primary objective of this study is to evaluate acute liver injury (ALI) rates associated with ELEVIDYS with the addition of sirolimus as an adjunct prophylactic immunosuppression agent.

Trial Details

NCT Number	NCT07542314
Lead Sponsor	Sarepta Therapeutics, Inc.
Conditions	Duchenne Muscular Dystrophy
Enrollment	20 participants
Start Date	2026-08-31
Primary Completion	2027-08-31 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-27