Trial · NCT01265498

The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)

NCT01265498, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2015-08-21

3 sourcestrials-2026-11-12-0.5.0

Download JSON

Cite this record

ConductScience Library. The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT). Trials, record NCT01265498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01265498

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)
NCT number: NCT01265498
Status: Completed
Phases: Phase 2
Enrollment: 283 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
Interventions: obeticholic acid, placebo
First posted: 2010-12-23
Last updated: 2018-04-06
Results first posted: 2015-08-21

Source ClinicalTrials.gov

Registered outcomes48

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)	baseline to 72 weeks	Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as: 1. No worsening in fibrosis; and 2. A decrease in NAFLD Activity Score (NAS) of at least 2 points
Secondary	Resolution of NASH Diagnosis	baseline to 72 weeks	Resolution of definite nonalcoholic steatohepatitis. Resolution defined as either not NAFLD, or NAFLD but not non-alcoholic steatohepatitis on week 72 biopsy
Secondary	Fibrosis: Patient With Improvement	baseline to 72 weeks	Patients with improvement in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis.
Secondary	Fibrosis: Change in Score	baseline to 72 weeks	Change in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis.
Secondary	Total NAFLD Activity Score: Change in Score	baseline to 72 weeks	NAFLD activity score was assessed on a scale of 0-8, with higher scores showing more severe disease (the components of this measure are steatosis \[assessed on a scale of 0-3\], lobular inflammation \[assessed on a scale of 0-3\], and hepatocellular ballooning \[assessed on a scale of 0-2\]).
Secondary	Hepatocellular Ballooning: Patients With Improvement	baseline to 72 weeks	Patients with improvement in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning.
Secondary	Hepatocellular Ballooning: Change in Score	baseline to 72 weeks	Change in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning.
Secondary	Steatosis: Patients With Improvement	baseline to 72 weeks	Patients with improvement in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis.
Secondary	Steatosis: Change in Score	baseline to 72 weeks	Change in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis.
Secondary	Lobular Inflammation: Patients With Improvement	baseline to 72 weeks	Patients with improvement in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation.

1 to 10 of 48Source ClinicalTrials.gov

See all 48 registered outcomes

Outcomes48

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)	baseline to 72 weeks	Number of randomly assigned patients with observed or expected week 72 visit before protocol modified on Jan 6, 2014, to eliminate week 72 biopsy. 11 patients in the placebo group and eight in the obeticholic acid group had missing histological data at week 72, and the results for these patients were imputed as a lack of improvement.	participants	NUMBER
SECONDARY	Resolution of NASH Diagnosis	baseline to 72 weeks	Number of patients with biopsy specimens at baseline and 72 weeks	participants	NUMBER
SECONDARY	Fibrosis: Patient With Improvement	baseline to 72 weeks	Number of patients with biopsy specimens at baseline and 72 weeks	participants	NUMBER
SECONDARY	Fibrosis: Change in Score	baseline to 72 weeks		units on a scale	MEAN
SECONDARY	Total NAFLD Activity Score: Change in Score	baseline to 72 weeks	Number of patients with biopsy specimens at baseline and 72 weeks	units on a scale	MEAN
SECONDARY	Hepatocellular Ballooning: Patients With Improvement	baseline to 72 weeks	Number of patients with biopsy specimens at baseline and 72 weeks	participants	NUMBER
SECONDARY	Hepatocellular Ballooning: Change in Score	baseline to 72 weeks	Number of patients with biopsy specimens at baseline and 72 weeks	units on a scale	MEAN
SECONDARY	Steatosis: Patients With Improvement	baseline to 72 weeks	Number of patients with biopsy specimens at baseline and 72 weeks	participants	NUMBER
SECONDARY	Steatosis: Change in Score	baseline to 72 weeks	Number of patients with biopsy specimens at baseline and 72 weeks	units on a scale	MEAN
SECONDARY	Lobular Inflammation: Patients With Improvement	baseline to 72 weeks	Number of patients with biopsy specimens at baseline and 72 weeks	participants	NUMBER

1 to 10 of 48Source ClinicalTrials.gov

See all 48 outcomes

Results by group96

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)	Obeticholic Acid	50		participants
Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)	Placebo	23		participants
Resolution of NASH Diagnosis	Obeticholic Acid	22		participants
Resolution of NASH Diagnosis	Placebo	13		participants
Fibrosis: Patient With Improvement	Obeticholic Acid	36		participants
Fibrosis: Patient With Improvement	Placebo	19		participants
Fibrosis: Change in Score	Obeticholic Acid	-0.2	Standard Deviation 1.0	units on a scale
Fibrosis: Change in Score	Placebo	0.1	Standard Deviation 0.9	units on a scale
Total NAFLD Activity Score: Change in Score	Obeticholic Acid	-1.7	Standard Deviation 1.8	units on a scale
Total NAFLD Activity Score: Change in Score	Placebo	-0.7	Standard Deviation 1.8	units on a scale

1 to 10 of 96Source ClinicalTrials.gov

See all 96 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Obeticholic Acid	141
Overall Study	STARTED	Placebo	142
Overall Study	Both Baseline and Week 72 Biopsy	Obeticholic Acid	102
Overall Study	Both Baseline and Week 72 Biopsy	Placebo	98
Overall Study	COMPLETED	Obeticholic Acid	110
Overall Study	COMPLETED	Placebo	109
Overall Study	NOT COMPLETED	Obeticholic Acid	31
Overall Study	NOT COMPLETED	Placebo	33

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Other cardiovascular event	Cardiac disorders	Obeticholic Acid	7	141	7
other	Other cardiovascular event	Cardiac disorders	Placebo	5	142	5
other	Dizziness or syncope	Nervous system disorders	Obeticholic Acid	3	141	3
other	Dizziness or syncope	Nervous system disorders	Placebo	4	142	4
other	Headache	Nervous system disorders	Obeticholic Acid	2	141	2
other	Headache	Nervous system disorders	Placebo	5	142	5
other	Neuralgia	Nervous system disorders	Obeticholic Acid	3	141	3
other	Neuralgia	Nervous system disorders	Placebo	2	142	2
other	Other neurological event	Nervous system disorders	Obeticholic Acid	4	141	4
other	Other neurological event	Nervous system disorders	Placebo	8	142	8

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Obeticholic Acid
Total, all-cause mortality	Placebo
Total, other adverse events	Obeticholic Acid	99	141
Total, other adverse events	Placebo	68	142
Total, serious adverse events	Obeticholic Acid	13	141
Total, serious adverse events	Placebo	10	142

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25468160	DERIVED	PubMed
29333665	DERIVED	PubMed
30253043	DERIVED	PubMed
31634532	DERIVED	PubMed
31965579	DERIVED	PubMed
33454241	DERIVED	PubMed
36368598	DERIVED	PubMed
40434633	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK061730	Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network	TONASCIA, JAMES A	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2002 to 2018

Source NIH RePORTER

Trial comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Obeticholic Acid vs Placebo: Steatosis: Patients With Improvement	Trial comparisons
Obeticholic Acid vs Placebo: Hepatocellular Ballooning: Patients With Improvement	Trial comparisons
Obeticholic Acid vs Placebo: Lobular Inflammation: Patients With Improvement	Trial comparisons
Obeticholic Acid vs Placebo: Portal Inflammation: Patients With Improvement	Trial comparisons
Obeticholic Acid vs Placebo: Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)	Trial comparisons
Obeticholic Acid vs Placebo: Fibrosis: Patient With Improvement	Trial comparisons
Obeticholic Acid vs Placebo: Resolution of NASH Diagnosis	Trial comparisons
Obeticholic Acid vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01265498

GET https://conductscience.org/api/trials/v1/NCT01265498/registered?page=2

API reference For AI assistants