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ENTR-601-44

Phase 2

Duchenne Muscular Dystrophy (DMD) | Small molecule | Neurology |Entrada Therapeutics, Inc.|Last Updated: Jul 2, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment104
FDA Designations
No designations recorded
Clinical trial landscape

ENTR-601-44 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT07682129Long-Term Extension Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon Skipping to Evaluate the Safety and Efficacy of Endosomal Escape Vehicle Phosphorodiamidate Morpholino Oligomer Platform Products (ELEVATE-LTE)Duchenne Muscular Dystrophy (DMD)
NOT YET_RECRUITING80 Analytics
PHASE2NOT YET_RECRUITING
Long-Term Extension Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon Skipping to Evaluate the Safety and Efficacy of Endosomal Escape Vehicle Phosphorodiamidate Morpholino Oligomer Platform Products (ELEVATE-LTE)
Duchenne Muscular Dystrophy (DMD)
NCT0768212980
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Study Endpoints
Primary Endpoints
Number of participants with Treatment Emergent Adverse Events (TEAEs) according to study protocol (Part A and OL Period)
From baseline through End of Study (up to 2 years).

Safety will be assessed by monitoring adverse events, physical examination, vital signs and clinical laboratory tests.

Number of participants with Treatment Emergent Adverse Events (TEAEs) according to study protocol (Part A and Open Label (OL) Period)
From baseline through End of Study (up to 62 weeks).

Safety will be assessed by monitoring adverse events, physical examination, vital signs and clinical laboratory tests.

Secondary Endpoints
Plasma concentration of study drug compounds and their final metabolite
From baseline through End of Study (up to 2 years).
Change from parent study Part A and OL Period baselines to LTE EOS in 10-Meter Walk/Run (10MWR)
From baseline through End of Study (up to 2 years).
Change from parent study Part A and OL Period baselines to LTE EOS in timed rise from floor (TRF)
From baseline through End of Study (up to 2 years).
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ENTR-601-44EXPERIMENTALENTR-601-44 intravenous infusion every 6 weeks
ENTR-601-45EXPERIMENTALENTR-601-45 intravenous infusion every 6 weeks
PlaceboPLACEBO_COMPARATORintravenous infusion every 6 weeks
Interventions
NameTypeDescription
ENTR-601-44DRUGENTR-601-44 intravenous infusion
ENTR-601-45DRUGENTR-601-45 intravenous infusion
ENTR-601-44 - matching placeboDRUGintravenous infusion
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Eligibility Criteria
Age Range4 Years to 20 Years
SexMALE
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Willing and able to provide consent (if at age of majority) or assent (if a minor) * Participant completed clinical study ENTR-601-44-201 or ENTR-601-45-201 * Males who are sexually active with a female partner of childbearing potential must agree to use condoms during sexual ...

Countries:BelgiumItalyNetherlandsSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJul 2, 2026NCT07682129NEW_TRIAL: changed
LOWJul 2, 2026NCT07682129NEW_TRIAL: changed
LOWJul 2, 2026NCT07682129NEW_TRIAL: changed
LOWMay 26, 2026NCT07037862primaryCompletionDate: changed
LOWMay 24, 2026NCT07037862studyFirstPostDate: changed