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ALN-HTT02

Phase 1

Huntington's Disease | Small molecule | Neurology |Alnylam Pharmaceuticals, Inc.|Last Updated: Aug 12, 2026

Target and mechanism

Molecular targetHuntingtin Gene
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

ALN-HTT02 · 1 trial · 1 indication

Phase 1 1
NCT06585449A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's DiseaseHuntington's Disease
RECRUITING66 Analytics
PHASE1RECRUITING
A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
Huntington's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency of Adverse Events (AEs) in the Double-blind Part of the Study
Up to 12 months
Frequency of AEs in the Open-label Part of the Study
Up to 12 months
Frequency of AEs in the OLE Part of the Study
Up to 36 months

Secondary Endpoints

Change from Baseline in Levels of Mutant Huntingtin (mHTT) in Cerebrospinal Fluid (CSF)
Baseline up to Month 12 in the Double-blind Part of the study; Baseline up to Month 12 in the Open-label Part of the study ; Baseline up to Month 36 in the OLE Part of the study
Concentrations of ALN-HTT02 in Plasma
Up to Month 12 in the Double-blind Part of the study; Up to Month 12 in the Open-label Part of the study; Up to Month 36 in the OLE Part of the study
Concentrations of ALN-HTT02 in Cerebrospinal Fluid (CSF)
Up to Month 12 in the Double-blind Part of the study; Up to Month 12 in the Open-label Part of the study ; Up to Month 36 in the OLE Part of the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALN-HTT02EXPERIMENTALParticipants will be administered a single dose of ALN-HTT02 during the Double-blind Part of the study. Participants who received ALN-HTT02 in the Double-blind part of the study will not receive an additional dose during the Open-label Part of the study. Participants have the option to receive repeat doses of ALN-HTT02 in the Open-label Extension (OLE) Part of the study.
Placebo + ALN-HTT02PLACEBO_COMPARATORParticipants will be administered a single dose of placebo during the Double-blind Part of the study. Participants will have the option to receive a single dose of ALN-HTT02 during the Open-label Part of the study. Participants have the option to receive repeat doses of ALN-HTT02 in the OLE Part of the study.

Interventions

NameTypeDescription
ALN-HTT02DRUGALN-HTT02 will be administered intrathecally
PlaceboDRUGPlacebo will be administered intrathecally
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Eligibility Criteria

Age Range25 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria * Has stage 2 or early Stage 3 Huntington's disease (HD), per the Huntington's Disease Integrated Staging System (HD-ISS) Exclusion Criteria * Has significant structural or degenerative neurologic disease other than Huntington's Disease (HD) at screening * Has primary or second...

Countries:CanadaGermanyUnited Kingdom
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Competitive Landscape -Huntington's Disease 8 trials

Recent Changes (Last 90 Days)

LOWAug 12, 2026NCT06585449lastUpdatePostDate: changed
LOWAug 12, 2026NCT06585449lastUpdatePostDate: changed
LOWJul 15, 2026NCT06585449lastUpdatePostDate: changed
LOWJul 15, 2026NCT06585449lastUpdatePostDate: changed
LOWJun 12, 2026NCT06585449lastUpdatePostDate: changed
LOWJun 12, 2026NCT06585449lastUpdatePostDate: changed

Frequently asked questions about ALN-HTT02

What is ALN-HTT02 used for?

ALN-HTT02 is an investigational small molecule being developed for the treatment of Huntington's disease, a progressive neurological disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does ALN-HTT02 target?

ALN-HTT02 targets the huntingtin gene, which is the genetic cause of Huntington's disease. By targeting this gene, the drug aims to address the underlying cause of the condition.

Who is developing ALN-HTT02?

ALN-HTT02 is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company. Alnylam is listed on the stock exchange under the ticker symbol ALNY.

What phase is ALN-HTT02 in?

ALN-HTT02 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for commercial use.

What clinical trials is ALN-HTT02 in?

ALN-HTT02 is being studied in a Phase 1 clinical trial with the identifier NCT06585449. This trial is recruiting adult patients with Huntington's disease and is being conducted in Canada, Germany, and the United Kingdom.

Is ALN-HTT02 the same as any other drug?

ALN-HTT02 is a distinct investigational drug candidate. It is not known to have any alternative names or to be the same as any other approved or investigational medication.