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

StatusRecruiting
PhasePhase 1
Started2024-10-14
View on ClinicalTrials.gov ↗

Amendment history

2026-08-11
3 amendments v17-v19
3 re-verifications since 2026-06-10, no change to tracked fields
2026-05-12
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 19 sites
2026-04-29
Study Status, Contacts/Locations v15
Study sitesdetails revised at 3 of 19 sites
2026-03-30
Study Status v14
Re-verified, no change to tracked fields
2026-02-26
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v13
Enrollment target54→66
Eligibility criteriarevised
[...] ULN) Has an estimated glomerular filtration rate (eGFR) of <4560 mL/min/1.73m^2 at screening Has received an investigational [...]
Secondary endpointsdetails revised at 4 of 4 entries
Primary endpoints2 to 3 entries
Frequency of AEs in the OLE Part of the Study
Study sitesdetails revised at 19 of 19 sites
Show 12 earlier versions
2025-12-18
Study Status, Contacts/Locations v12
Study sitesdetails revised at 19 of 19 sites
2025-11-12
Study Status, Contacts/Locations v11
Study sites17→19
2025-10-15
Study Status, Contacts/Locations v10
Study sites16→17
2025-09-16
3 amendments v7-v9
3 re-verifications since 2025-07-15, no change to tracked fields
2025-06-19
Study Status, Contacts/Locations v6
Study sites12→16
2025-05-01
Study Status, Contacts/Locations v5
Study sites3→12
2025-01-08
Study Status v4
Re-verified, no change to tracked fields
2024-12-19
Study Status, Contacts/Locations v3
Start dateestimated 2024-11-12→confirmed 2024-10-14
Study sites2→3
2024-11-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-12-15→2028-07-05
Start date2024-10-31→2024-11-12
Study sites1→2
2024-10-11
Study Status, Contacts/Locations v1
Start date2024-09-30→2024-10-31
Study sites0→1
2024-09-03
Original filing
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single or repeat doses of ALN-HTT02.
Trial Details
NCT Number NCT06585449
Lead Sponsor Alnylam Pharmaceuticals
Conditions Huntington's Disease
Enrollment 66 participants
Start Date 2024-10-14
Primary Completion 2028-07-05 (estimated)
Study Completion 2028-07-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-16