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NASHGEN-2NCT05519475

A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 44 versions: 43 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Site details revised at 71 of 71 sites
  2. Study sites revised (71)
  3. Eligibility criteria expanded, about 10 words
    • Study sites revised (71)
  4. Site details revised at 1 of 71 sitesv41
  5. Site details revised at 1 of 71 sitesv40
  6. Site details revised at 1 of 71 sitesv39
  7. Primary completion pushed from Sep 8, 2027 to Apr 27, 2028v38 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria shortened, about 2 words
    • Enrollment increased: 90 → 120 participants
    • Study completion pushed from Sep 8, 2027 to Dec 7, 2028
    • Secondary endpoints revised (12)
    • Site details revised at 1 of 71 sites
  8. Study sites revised (71)v37
  9. Site details revised at 3 of 71 sitesv36
  10. Site details revised at 3 of 71 sitesv35
  11. Study sites revised (71)v34
  12. Study sites: 70 to 71v32
  13. Study sites: 68 to 70v31
  14. Study sites: 66 to 68v30
  15. Study sites: 65 to 66v29
  16. Study sites: 63 to 65v28
  17. Eligibility criteria expanded, about 24 wordsv27 Show 4 more changesShow less
    • Enrollment target: 120 to 90
    • Secondary endpoints revised (12)
    • Study sites revised (63)
    • Study title expanded, about 1 word
  18. Study sites: 62 to 63v26
  19. Study sites: 61 to 62v25
  20. Study sites: 62 to 61v24
  21. Study sites: 56 to 62v23
  22. Study sites: 53 to 56v22
  23. Study sites: 48 to 53v21
  24. Site details revised at 1 of 48 sitesv20
  25. Study sites: 42 to 48v19
  26. Study sites revised (42)v18
  27. Site details revised at 3 of 42 sitesv17
  28. Study sites: 36 to 42v16
  29. Study sites: 35 to 36v15
  30. Study sites revised (35)v14
  31. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 34 to 35
    v13
  32. Enrollment target: 300 to 120v12 Show 6 more changesShow less
    • Primary and study completion dates: Dec 9, 2026 to Sep 8, 2027
    • Primary endpoint revised
    • Eligibility criteria shortened, about 4 words
    • Secondary endpoints revised (12)
    • Study arms: 6 to 2
    • Study title expanded, about 4 words
  33. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 35 to 34
    v11
  34. Study sites: 34 to 35v10
  35. Study sites: 32 to 34v9
  36. Study sites: 25 to 32v8
  37. Study sites: 19 to 25v7
  38. Study sites: 17 to 19v6
  39. Study sites: 3 to 17v5
  40. Eligibility criteria expanded, about 30 words
    • Study sites: 2 to 3
    v4
  41. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Primary and study completion dates: Dec 6, 2026 to Dec 9, 2026
    • Start date changed from estimate of Jan 30, 2023 to Feb 9, 2023
    v3
  42. Start date: Oct 25, 2022 to Jan 30, 2023
    • Eligibility criteria expanded, about 1 word
    • Primary and study completion dates: Aug 17, 2026 to Dec 6, 2026
    v2
  43. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change in quantitative liver Fibrosis (qFibrosis)
Timeframe: Baseline to week 52

Secondary (12)

Improvement of Non-Alcoholic Steatohepatitis Clinical Research Network (NASH-CRN) Fibrosis (F) stage by ≥1 stage without worsening of MASH on liver biopsy
Resolution of MASH with no worsening of NASH-CRN fibrosis on liver biopsy
Change in serum ALanine aminoTransferase (ALT)
Change in serum ASpartate aminoTransferase (AST)
Change in Enhanced Liver Fibrosis (ELF)
Show 7 moreShow less
Change in N-terminal type III Collagen PROropeptide (PRO-C3)
Change in NIS4, a non-invasive fibrosis biomarker of NASH
Change in Fibrosis-4 (FIB-4)
Change in hepatic HydroxySteroiD 17β dehydrogenase 13 (HSD17B13) transcript level
Incidence of progression in qFibrosis on liver biopsy
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Severity of TEAEs

Arms and interventions

ALN-HSDExperimental

Randomized 1:1

PlaceboPlacebo comparator

Randomized 1:1

Drugs: ALN-HSD, Placebo

Sites

71 sites in 4 countries

United States 61, South Korea 5, Puerto Rico 4, Japan 1