DrugEvidence

Diseases / Fatty Liver

Fatty Liver

Disease

Fatty liver disease, also called hepatic steatosis, is a condition characterized by excess fat accumulation in liver tissue. Many patients are asymptomatic, but disease can progress to steatohepatitis, fibrosis, cirrhosis, and liver cancer in a subset of individuals. Major risk factors include obesity, diabetes, and alcohol use.

Trials
589
Recruiting
80
Completed
306
With results
76

Last revised

Pipeline

Phase by status

PhaseRecruitingNot yetBy invitationActiveCompletedTerminatedWithdrawnSuspendedUnknownTotal
Early Phase 1 511 7
Phase 1 510621 24
Phase 1/2 51821 17
Phase 2 91343824 70
Phase 2/3 132 6
Phase 3 619323 24
Phase 4 31121316 36
Not applicable 2410531307932 220
Unknown 2814267734150 185

Trials started per year

2021
5
2022
41
2023
51
2024
57
2025
35
2026
31

Conditions studied, by phase

ConditionEarly Phase 1Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Not applicableUnknownTotal
Fatty Liver 724177062436220185 589
Non-alcoholic Fatty Liver Disease 391051317148864 259
Obesity 26481254034 102
Liver Cirrhosis 154131939 72
Insulin Resistance 1113152810 59
Metabolic Syndrome 112152218 50
Liver Diseases 1411441213 49
Diabetes Mellitus, Type 2 1426113138 48
Fibrosis 13107521 47
Diabetes Mellitus 2111261111 44

Most active sponsors

#SponsorTrialsPhase 3
1National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)132
2Assiut University91
3Seoul National University Hospital70
4Cairo University60
5Massachusetts General Hospital60
6Tehran University of Medical Sciences60
7University of Colorado, Denver62
8National Institute of Allergy and Infectious Diseases (NIAID)50
9University of Oxford50
10University of Texas Southwestern Medical Center50

Most studied interventions

#InterventionTrials
1Exercise15
2Vitamin E13
3Pioglitazone12
4Diet11
5Metformin8
6Ultrasonography8
7Diet Therapy7
8empagliflozin7
9Caloric Restriction6
10Diet, Fat-Restricted6

Evidence

Results reported
24.8%76 of 306 completed
Published
13.4%41 of 306 completed
Primary endpoint met
50.8%32 of 63 analyses
Median months to report
16

Documents disclosed

Protocol available
52
Statistical analysis plan
51
PubMed citations
162

Trial profile

Median enrollment
65
Median duration
26.8months
Countries
58
Study sites
2616

Who is enrolled

Adults
571
Children
79
Older adults
476
Healthy volunteers
164

Median enrollment by phase

Early Phase 1
31
Phase 1
32
Phase 1/2
44
Phase 2
60
Phase 2/3
75
Phase 3
100
Phase 4
50
Not applicable
50
Unknown
138

Where trials run

United States
196
China
43
United Kingdom
41
France
40
Canada
39
Italy
32
Germany
25
Spain
25
Turkey (Türkiye)
23
Israel
21

Busiest cities

#CityCountryTrials
1San AntonioUnited States35
2DallasUnited States24
3LondonUnited Kingdom23
4HoustonUnited States22
5Los AngelesUnited States22
6New YorkUnited States21
7ParisFrance21
8MiamiUnited States20
9RichmondUnited States20
10BostonUnited States19

Terminations

Terminated
32
Withdrawn
21
Suspended
1
Stopped for recruitment
1.4%8 of 589 trials

Stated reasons

Other / unclear
27
Funding
8
Recruitment
8
Business decision
5
Regulatory
4
COVID-19
1
Safety
1

Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.

Recently stopped

TrialStatusStated reasonStopped
NCT06594523 Withdrawn Withdrawn Business decision 2030-12-31
NCT04160949 Withdrawn Withdrawn Company focus shifted 2030-07-31
NCT01148550 Suspended Suspended 2029-05-31
NCT06692283 Withdrawn Withdrawn Business decision 2027-06-30
NCT03542578 Terminated Terminated Changes in the study staff's role and clinic commitments 2026-07-09
NCT04302051 Withdrawn Withdrawn The sponsor withdrew from the study 2026-07-09
NCT05769127 Withdrawn Withdrawn funding withdrawn 2025-06-10
NCT03914482 Withdrawn Withdrawn The qualified and Principal Investigator has moved institutes. We are in the process for finding a replacement. 2024-12-30
NCT07052682 Terminated Terminated Study was terminated early by the sponsor due to a strategic shift and reprioritization of clinical programs within Takeda. 2024-12-30
NCT05864391 Terminated Terminated AstraZeneca have decided to not move forward with the development of the compound. 2024-03-20

Trial records