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A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

Study acronym: InsigHHT
StatusActive, Not Recruiting
PhasePhase 1/2
Started2024-11-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 26% 120 → 89 participants
See other at-risk trials from Alnylam Pharmaceuticals

Amendment history

2026-08-11
Study Status v19
Re-verified, no change to tracked fields
2026-07-13
Study Status, Study Design, Contacts/Locations v18
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment reduced: 120 → 89 participants
Study sitesdetails revised at 16 of 16 sites
2026-06-10
Study Status, Contacts/Locations v17
Study sitesdetails revised at 1 of 16 sites
2026-05-12
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 16 sites
2026-04-29
Study Status, Contacts/Locations v15
Trial sites expanded: 8 → 16 locations
Show 14 earlier versions
2026-03-30
Study Identification, Study Status v14
Re-verified, no change to tracked fields
2026-02-04
Study Status, Eligibility, Contacts/Locations v13
Start date2024-11-11→2024-11-07
Study sites17→8
2025-12-18
Study Status, Contacts/Locations v12
Completion date2028-06-21→2028-06-22
Study sites2→17
2025-11-10
Study Status v11
Re-verified, no change to tracked fields
2025-10-15
Study Status, Contacts/Locations v10
Primary completion date2026-08-19→2028-01-05
Completion date2028-06-22→2028-06-21
Study sitesdetails revised at 1 of 2 sites
2025-09-29
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v9
Trial statusActive, Not Recruiting→Recruiting
Study sites1→2
2025-09-16
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-09-10→2026-08-19
Enrollment target96→120
Study sitesdetails revised at 1 of 1 site
2025-09-04
Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing v7
PhasePhase 1→Phase 1/2
Completion date2026-02-25→2028-06-22
Enrollment target32→96
Study arms2→4
Eligibility criteria+195 characters
Inclusion Criteria - Part A: Is a healthy adult volunteer Part B: Is an adult patient with a clinical diagnosis of HHT Exclusion Criteria - Part A: Has alanine aminotransferase (ALT) or aspartate aminotransfe [...] erular filtration (eGFR) of <90 mL/min/1.73m^2 at screening Part B: Has ALT or AST >2×ULN Has total bilirubin >1.5×ULN Has eGFR of <30 mL/min/1.73m^2 at screening Parts A and B: Is not willing to comply with the contraceptive requirements [...]
Secondary endpoints2 to 17 entries
Part A: Concentrations of ALN-6400 in Plasma Part A: Change from Baseline in thePlasminogen ALN-6400 Target(PLG) in Plasma Protein Levels Part B: Change from Baseline in Plasminogen (PLG) in Plasma Protein Levels Part A: Change from Baseline in Plasminogen (PLG) in Plasma Activity Levels Part B: Change from Baseline in Plasminogen (PLG) in Plasma Activity Levels Part B: Change from Baseline in Intensity-adjusted Epista [...]
Primary endpoints1 to 2 entries
Part A: Frequency of Adverse Events Part B: Frequency of Adverse Events
Study title+56 characters
A Study to Evaluate ALN-6400 in Adult Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
2025-05-09
4 amendments v3-v6
4 re-verifications since 2025-01-08, no change to tracked fields
2024-12-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-05-29→2025-09-10
Completion date2026-05-29→2026-02-25
Start dateestimated 2024-11-12→confirmed 2024-11-11
Study sitesdetails revised at 1 of 1 site
2024-11-07
Study Status v1
Re-verified, no change to tracked fields
2024-10-24
Original filing
The purpose of this study is to: * evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers * evaluate the efficacy, safety, tolerability and PD of multiple doses of ALN-6400 in adult patients with HHT
Trial Details
NCT Number NCT06659640
Lead Sponsor Alnylam Pharmaceuticals
Conditions Hereditary Hemorrhagic Telangiectasia
Enrollment 89 participants
Start Date 2024-11-07
Primary Completion 2028-01-05 (estimated)
Study Completion 2028-06-22 (estimated)
Updated on ClinicalTrials.gov 2026-09-16