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Condition (MeSH)

Non-alcoholic Fatty Liver Disease

ClinicalTrials.gov lists 1,607 trials for Non-alcoholic Fatty Liver Disease or a narrower condition beneath it. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has the most among industry and government lead sponsors, with 20.

MeSH D065626 Digestive System Diseases C06 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 160 Phase 1/2 Phase 1/2 36 Phase 2 Phase 2 295 Phase 2/3 Phase 2/3 18 Phase 3 Phase 3 72 Phase 4 Phase 4 81 Not applicable Not applicable 549 Observational Observational 394 Phase 1 Phase 1 160 Phase 1/2 Phase 1/2 36 Phase 2 Phase 2 295 Phase 2/3 Phase 2/3 18 Phase 3 Phase 3 72 Phase 4 Phase 4 81 Not applicable Not applicable 549 Observational Observational 394

Trials per phase (log scale)

1 more section with rows

1,607 of the 1,607 trials are tagged with Non-alcoholic Fatty Liver Disease itself; the rest are tagged with a narrower condition beneath it.

Get the Non-alcoholic Fatty Liver Disease report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Non-alcoholic Fatty Liver Disease trials start? (28)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 3 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational
  • Other (Unknown)

Top of scale: 160

1997: 1 trials (Observational 1) 2000: 1 trials (Phase 2 1) 2001: 2 trials (Observational 1, Phase 2 1) 2002: 2 trials (Not applicable 1, Phase 4 1) 2003: 8 trials (Observational 1, Phase 4 1, Phase 2/3 1, Phase 2 5) 2004: 10 trials (Observational 1, Not applicable 4, Phase 4 1, Phase 3 1, Phase 2/3 1, Phase 1/2 1, Phase 1 1) 2005: 13 trials (Observational 1, Not applicable 7, Phase 3 3, Phase 2/3 1, Phase 2 1) 2006: 11 trials (Observational 3, Not applicable 2, Phase 2/3 1, Phase 2 4, Phase 1 1) 2007: 18 trials (Observational 5, Not applicable 5, Phase 3 2, Phase 2/3 1, Phase 2 5) 2008: 25 trials (Observational 6, Not applicable 6, Phase 4 3, Phase 3 1, Phase 2 6, Phase 1/2 1, Phase 1 2) 2009: 34 trials (Observational 9, Not applicable 14, Phase 4 4, Phase 3 2, Phase 2 2, Phase 1/2 2, Phase 1 1) 2010: 24 trials (Observational 3, Not applicable 9, Phase 4 1, Phase 3 1, Phase 2 7, Phase 1/2 2, Phase 1 1) 2011: 34 trials (Observational 7, Not applicable 10, Phase 4 4, Phase 3 4, Phase 2/3 1, Phase 2 6, Phase 1 2) 2012: 40 trials (Observational 9, Not applicable 16, Phase 4 1, Phase 3 1, Phase 2/3 3, Phase 2 10) 2013: 51 trials (Observational 12, Not applicable 19, Phase 4 3, Phase 3 1, Phase 2/3 1, Phase 2 11, Phase 1 4) 2014: 50 trials (Observational 13, Not applicable 12, Phase 4 8, Phase 3 5, Phase 2/3 3, Phase 2 8, Phase 1 1) 2015: 83 trials (Observational 22, Not applicable 27, Phase 4 5, Phase 3 2, Phase 2/3 1, Phase 2 18, Phase 1/2 2, Phase 1 6) 2016: 76 trials (Other 1, Observational 19, Not applicable 26, Phase 4 3, Phase 3 2, Phase 2 18, Phase 1/2 1, Phase 1 6) 2017: 87 trials (Observational 20, Not applicable 33, Phase 4 1, Phase 3 5, Phase 2/3 1, Phase 2 18, Phase 1/2 1, Phase 1 8) 2018: 93 trials (Other 1, Observational 25, Not applicable 34, Phase 4 5, Phase 3 1, Phase 2 12, Phase 1/2 2, Phase 1 13) 2019: 145 trials (Observational 33, Not applicable 50, Phase 4 6, Phase 3 6, Phase 2/3 1, Phase 2 35, Phase 1/2 6, Phase 1 8) 2020: 125 trials (Observational 31, Not applicable 41, Phase 4 4, Phase 3 3, Phase 2/3 2, Phase 2 22, Phase 1/2 3, Phase 1 19) 2021: 149 trials (Observational 26, Not applicable 57, Phase 4 5, Phase 3 5, Phase 2 28, Phase 1/2 5, Phase 1 23) 2022: 127 trials (Observational 40, Not applicable 47, Phase 4 6, Phase 3 4, Phase 2 18, Phase 1/2 2, Phase 1 10) 2023: 160 trials (Observational 42, Not applicable 45, Phase 4 10, Phase 3 6, Phase 2 27, Phase 1/2 4, Phase 1 26) 2024: 112 trials (Observational 30, Not applicable 44, Phase 4 6, Phase 3 5, Phase 2 14, Phase 1/2 2, Phase 1 11) 2025: 67 trials (Observational 19, Not applicable 22, Phase 4 2, Phase 3 6, Phase 2 9, Phase 1/2 1, Phase 1 8)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 53
2025 67
2024 112
2023 160
2022 127
2021 149
2020 125
2019 145
2018 93
2017 87

Showing 10 of 28 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 62 trials starting in 2026 and about 65 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 13 percent and ran about 12 percent low against the count later registered; forecasts made before the year began were off by about 19 percent and ran about 17 percent low against the count later registered, and had about the same error as repeating last year's count. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 137 trials still running at the 2026-10-09 snapshot; registered median of 21 months across 973 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Non-alcoholic Fatty Liver Disease trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 160
Phase 1/2 36
Phase 2 295
Phase 2/3 18
Phase 3 72
Phase 4 81
Not applicable 549
Observational 394
Unknown 2

How many Non-alcoholic Fatty Liver Disease trials are recruiting? (9)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 54
Recruiting 180
Enrolling by invitation 19
Active, not recruiting 79
Completed 833

Showing 5 of 9 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Non-alcoholic Fatty Liver Disease trials? (6)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 20
Gilead Sciences 16
Pfizer 15
AstraZeneca 14
Novo Nordisk A/S 12

Showing 5 of 6 sponsors.

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Which drugs are being tested for Non-alcoholic Fatty Liver Disease? (6)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Semaglutide 14
Saroglitazar 9
Obeticholic Acid 8
ATORVASTATIN 8
BMS-986036 8

Showing 5 of 6 drugs.

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Interventions as named in the registry (9)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
1% Metformin 23
Pioglitazone - TZD 20
Liver biopsy 17
Empagliflozine 17
Vitamin E 13

Showing 5 of 9 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Non-alcoholic Fatty Liver Disease trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Other 96 1
Pneumonia 77 26
Non-cardiac chest pain 74 27
Sepsis 72 23
Cellulitis 71 25

Showing 5 of 10 adverse events.

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Which publications cover Non-alcoholic Fatty Liver Disease? (1,533)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Exploration of Multiple Non-Invasive Tests for Assessing Response to Treatment in a Semaglutide Phase 2b Trial in Patients with MASH. Alimentary pharmacology & therapeutics 2026 Yes
Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. Journal of hepatology 2025 Yes
Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis. The New England journal of medicine 2025 Yes
Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 2025 Yes
Aramchol improves hepatic fibrosis in metabolic dysfunction-associated steatohepatitis: Results of multimodality assessment using both conventional and digital pathology. Hepatology (Baltimore, Md.) 2025 Yes

Showing 5 of 1,533 publications.

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Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence, rare-disease identity, and sub-conditions in mesh.

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