A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease

Last updated: April 29, 2026
Sponsor: Alnylam Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1

Condition

Dyskinesias

Memory Loss

Huntington's Disease

Treatment

Placebo

ALN-HTT02

Clinical Study ID

NCT06585449
ALN-HTT02-001
  • Ages 25-70
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single or repeat doses of ALN-HTT02.

Eligibility Criteria

Inclusion

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 secondary immune compromise at screening due to infections, medical conditions, or chronic therapies

  • Has alanine aminotransferase or aspartate aminotransferase >2× upper limit of normal (ULN)

  • Has an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m^2 at screening

  • Has received an investigational agent within the last 1 year or 5 half-lives (if known)

Note: other protocol defined inclusion / exclusion criteria apply

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 14, 2024
Estimated Completion Date:
July 05, 2028

Connect with a study center

  • Clinical Trial Site

    Edmonton, T6G 2B7
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Edmonton 5946768, T6G 2B7
    Canada

    Site Not Available

  • Clinical Trial Site

    Montreal, H2W 1T8
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Montreal 6077243, H2W 1T8
    Canada

    Site Not Available

  • Clinical Trial Site

    Ottawa, K1Y4E9
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Ottawa 6094817, K1Y4E9
    Canada

    Site Not Available

  • Clinical Trial Site

    Ottowa,
    Canada

    Site Not Available

  • Clinical Trial Site

    Vancouver, V6T 2B5
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Vancouver 6173331, V6T 2B5
    Canada

    Site Not Available

  • Clinical Trial Site

    Ulm 2820256, Baden-Wurttemberg 2953481 89081
    Germany

    Site Not Available

  • Clinical Trial Site

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Site Not Available

  • Clinical Trial Site

    Berlin 2950159, State of Berlin 2950157 10117
    Germany

    Site Not Available

  • Clinical Trial Site

    Bayern,
    Germany

    Site Not Available

  • Clinical Trial Site

    Bayern 2951841,
    Germany

    Site Not Available

  • Clinical Trial Site

    Berlin, 10117
    Germany

    Site Not Available

  • Clinical Trial Site

    Bochum, 44791
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Bochum 2947416, 44791
    Germany

    Site Not Available

  • Clinical Trial Site

    Bonn, 53127
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Bonn 2946447, 53127
    Germany

    Site Not Available

  • Clinical Trial Site

    Dresden, 01307
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Münster, 48149
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Münster 2867543, 48149
    Germany

    Site Not Available

  • Clinical Trial Site

    Taufkirchen, 84416
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Taufkirchen 2823812, 84416
    Germany

    Site Not Available

  • Clinical Trial Site

    Ulm, 89081
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Venusberg,
    Germany

    Site Not Available

  • Clinical Trial Site

    Venusberg 2817616,
    Germany

    Site Not Available

  • Clinical Trial Site

    Manchester 2643123, MAN M13 9WL
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Birmingham, B15 2TT
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Birmingham 2655603, B15 2TT
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Cambridge, CB2 0PY
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Cambridge 2653941, CB2 0PY
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Cardiff, CF103AX
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Cardiff 2653822, CF103AX
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Glasgow, G51 4TF
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Glasgow 2648579, G51 4TF
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Greater Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    London, WC1N 3BG
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    London 2643743, WC1N 3BG
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Manchester,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Oxford, OX3 9DU
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Oxford 2640729, OX3 9DU
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Plymouth 2640194, PL6 8DH
    United Kingdom

    Site Not Available

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