deltatrials
Terminated PHASE1 INTERVENTIONAL 5-arm NCT04565717

A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 3-Part Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-HSD in Healthy Adult Subjects and Multiple Dose ALN-HSD in Adult Patients With Nonalcoholic Steatohepatitis (NASH)

Sponsor: Alnylam Pharmaceuticals

Interventions ALN-HSD Placebo
Updated 39 times since 2020 Last updated: May 16, 2024 Started: Oct 9, 2020 Primary completion: Jan 6, 2023 Completion: Dec 21, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study ALN-HSD-001 was terminated due to business reasons and changes in the development strategy of the product. No safety issues were found.

Listed as NCT04565717, this PHASE1 trial focuses on NASH and Nonalcoholic Steatohepatitis and remains terminated or withdrawn. Sponsored by Alnylam Pharmaceuticals, it has been updated 39 times since 2020, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Jun 2023 · 2 months · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Sep 2023 · 2 months · monthly snapshot~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Mar 2024 · 2 months · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jun 2024 · 2 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

39 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  4. Jun 2024 — Jul 2024 [monthly]

    Terminated PHASE1

  5. Apr 2024 — Jun 2024 [monthly]

    Terminated PHASE1

    Status: CompletedTerminated

Show 34 earlier versions
  1. Mar 2024 — Apr 2024 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

  2. Jan 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Dec 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Nov 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  5. Sep 2023 — Nov 2023 [monthly]

    Recruiting PHASE1

  6. Jul 2023 — Sep 2023 [monthly]

    Recruiting PHASE1

  7. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE1

    Status: Active Not RecruitingRecruiting

  8. Apr 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE1

  9. Mar 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE1

  10. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE1

  11. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE1

  12. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE1

  13. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE1

  14. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE1

  15. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

  16. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

  17. May 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE1

  18. Apr 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE1

  19. Mar 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  20. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE1

  21. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE1

  22. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

  23. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE1

  24. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE1

  25. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

  26. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  27. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE1

  28. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE1

  29. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1

  30. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1

  31. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  32. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  33. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  34. Oct 2020 — Nov 2020 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Alnylam Pharmaceuticals
Data source: Alnylam Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .