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Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

Study acronym: ESSENCE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 179 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S Show 5 more changesShow less
    • Primary endpoints: details revised at 3 of 3 entries
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 11 of 35 entries
    • Site details revised at 61 of 558 sites
    • Publications: details revised at 5 of 5 entries
  2. Study sites: 557 to 558v178
  3. Re-verified, no change to tracked fieldsv177
  4. Site details revised at 1 of 557 sitesv176
  5. Study sites: 556 to 557v175
  6. Study sites revised (556)v174
  7. Trial sites expanded: 552 → 556 locationsv173
  8. Study sites: 410 to 552v172
  9. Study sites: 411 to 410v171
  10. Study sites: 408 to 411v170
  11. Study sites: 399 to 408v169
  12. Study sites revised (399)v168
  13. Study sites: 400 to 399v167
  14. Study sites: 404 to 400v166
  15. Study sites: 408 to 404v165
  16. Enrollment target: estimated 1200 to confirmed 1205
    • Study sites: 411 to 408
    • Secondary endpoints: 34 to 35
    v164
  17. Study sites: 429 to 411v163
  18. Study sites: 432 to 429v162
  19. Study sites: 437 to 432v161
  20. Study sites: 445 to 437v160
  21. Study sites: 446 to 445
    • Publications: details revised at 1 of 5 entries
    v159
  22. Re-verified, no change to tracked fieldsv158
  23. Study sites revised (446)v157
  24. Study sites: 448 to 446v156
  25. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 528 to 448
    v155
  26. Site details revised at 7 of 528 sitesv154
  27. Study sites revised (528)v153
  28. Site details revised at 1 of 528 sitesv152
  29. Study sites revised (528)v151
  30. Study sites revised (528)v150
  31. Study sites: 524 to 528v149
  32. Site details revised at 13 of 524 sitesv148
  33. Study sites: 522 to 524v147
  34. Site details revised at 7 of 522 sitesv146
  35. Site details revised at 2 of 522 sitesv145
  36. Site details revised at 1 of 522 sitesv144
  37. Study sites: 520 to 522v143
  38. Site details revised at 1 of 520 sitesv142
  39. Study sites: 518 to 520v141
  40. Study sites: 517 to 518v140
  41. Study sites revised (517)v139
  42. Study sites revised (517)v138
  43. Study sites: 516 to 517v137
  44. Primary completion date: Mar 7, 2029 to Apr 25, 2029v136
  45. Site details revised at 1 of 516 sitesv135
  46. Study sites: 515 to 516v134
  47. Study sites: 512 to 515v133
  48. Site details revised at 1 of 512 sitesv132
  49. Study sites: 511 to 512v131
  50. Study sites revised (511)v130
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novo Nordisk
268 trials monitored
See 15 trials at risk
NASH / MASH
687 trials monitored
See 22 trials at risk
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.
Trial Details
NCT Number NCT04822181
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)		 Non-alcoholic Steatohepatitis
Related terms Non-alcoholic Fatty Liver Disease
Enrollment 1,205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov