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KER-065

Phase 2

Duchenne Muscular Dystrophy | Small molecule | Neurology |Keros Therapeutics, Inc.|Last Updated: Jul 15, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
ORPHAN_DRUG
Clinical trial landscape

KER-065 · 1 trial · 1 indication

Phase 2 1
NCT07704099Safety and Efficacy of KER-065 in Participants With Duchenne Muscular DystrophyDuchenne Muscular Dystrophy
NOT YET_RECRUITING36 Analytics
PHASE2NOT YET_RECRUITING
Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy
Duchenne Muscular DystrophyUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of participants with treatment-emergent adverse events (TEAEs and serious adverse events (SAEs)
Up to approximately 3 years

To evaluate the safety and tolerability of KER-065 in ambulatory and nonambulatory participants with DMD

Secondary Endpoints
KER-065 serum concentration by visit, as appropriate
Up to Week 100
Number and proportion of participants with treatment-emergent ADA (antidrug antibody) by visit
Up to Week 100
Change from baseline by visit in bone mineral density (BMD), fat mass, and lean body mass, as measured by dual- energy X-ray absorptiometry (DXA)
Up to Week 96
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A1 (Late Ambulatory)EXPERIMENTALParticipants will receive stable corticosteroid (CS) along with KER-065.
Cohort A2 (Late Ambulatory)EXPERIMENTALParticipants will receive stable CS, exon skipper along with KER-065.
Cohort N1 (Nonambulatory)EXPERIMENTALParticipants will receive stable CS along with KER-065.
Interventions
NameTypeDescription
KER-065DRUGKER-065 will be administered subcutaneously (SC)
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Eligibility Criteria
Age Range9 Years to N/A
SexMALE
Healthy VolunteersNo

Key Inclusion Criteria: * Diagnosis of DMD, defined as the presence of phenotypic features at screening consistent with DMD AND documented mutation in the dystrophin gene consistent with the diagnosis of DMD using a clinically validated genetic test. * Receiving a stable regimen of systemic CS (inc...

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Recent Changes (Last 90 Days)
LOWJul 15, 2026NCT07704099NEW_TRIAL: changed
LOWJul 15, 2026NCT07704099NEW_TRIAL: changed