Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): A multicentre, randomised, placebo-controlled trial
Open accessAbstract
Background The bile acid derivative 6-ethylchenodeoxycholic acid (obeticholic acid) is a potent activator of the farnesoid X nuclear receptor that reduces liver fat and fibrosis in animal models of fatty liver disease. We assessed the efficacy of obeticholic acid in adult patients with non-alcoholic steatohepatitis.Methods We did a multicentre, double-blind, placebo-controlled, parallel group, randomised clinical trial at medical centres in the USA in patients with non-cirrhotic, non-alcoholic steatohepatitis to assess treatment with obeticholic acid given orally (25 mg daily) or placebo for 72 weeks. Patients were randomly assigned 1:1 using a computer-generated, centrally administered procedure, stratified by clinical centre and diabetes status. The primary outcome measure was improvement in centrally scored liver histology defined as a decrease in non-alcoholic fatty liver disease activity score by at least 2 points without worsening of fibrosis from baseline to the end of treatment. A planned interim analysis of change in alanine aminotransferase at 24 weeks undertaken before end-of-treatment (72 weeks) biopsies supported the decision to continue the trial (relative change in alanine aminotransferase -24%, 95% CI -45 to -3). A planned interim analysis of the primary outcome showed improved efficacy of obeticholic acid (p=0·0024) and supported a decision not to do end-of-treatment biopsies and end treatment early in 64 patients, but to continue the trial to obtain the 24-week post-treatment measures. Analyses were done by intention-to-treat. This trial was registered with ClinicalTrials.gov, number NCT01265498.Findings Between March 16, 2011, and Dec 3, 2012, 141 patients were randomly assigned to receive obeticholic acid and 142 to placebo. 50 (45%) of 110 patients in the obeticholic acid group who were meant to have biopsies at baseline and 72 weeks had improved liver histology compared with 23 (21%) of 109 such patients in the placebo group (relative risk 1·9, 95% CI 1·3 to 2·8; p=0·0002). 33 (23%) of 141 patients in the obeticholic acid developed pruritus compared with nine (6%) of 142 in the placebo group.Interpretation Obeticholic acid improved the histological features of non-alcoholic steatohepatitis, but its long-term benefits and safety need further clarification.Funding National Institute of Diabetes and Digestive and Kidney Diseases, Intercept Pharmaceuticals.
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FXR regulates other pathways with direct antiinflammatory and antifibrotic effects.
“In addition, FXR regulates other pathways with direct antiinflammatory and antifibrotic effects. 13-15”
From A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis (2016) · cites this paper as [14]
The Discussion’s Systematic review says FXR agonists have indirect anti-fibrotic effects in animal models, contrary to the claim of direct anti-fibrotic effects. The cited passages do not describe direct anti-inflammatory effects or identify such pathways; page numbers are unavailable in our copy. (LLM, conf=0.84)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredIn the FLINT trial, pruritus was the main side effect of obeticholic acid (33% vs. 6% placebo).
“Pruritus was the main side effect of obeticholic acid (33% vs. 6% placebo) [46].”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [46]
The Results identify pruritus as the symptom that differed between groups, supporting its description as the main side effect. But 33 is the number of obeticholic acid-treated patients who reported pruritus, not the percentage: the rates were 23% versus 6% with placebo. (LLM, conf=0.94)
Experimental — accuracy not yet measuredIn the FLINT trial, obeticholic acid improved fibrosis in 35% of patients versus 19% in the placebo arm (p = 0.004).
“Importantly however obeticholic acid improved fibrosis in 35% of patients versus only 19% in the placebo arm (p = 0.004) [46].”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [46]
The Results section states that more patients assigned to obeticholic acid than placebo had improvement in fibrosis. The passages in our copy do not give the claimed fibrosis-specific rates of 35% versus 19% or p = 0.004; the nearby 45% versus 21% result concerns a different, primary histological outcome. (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn the FLINT trial, significantly more patients in the obeticholic acid arm (45%) versus placebo (21%) showed improved liver histology (decrease in NAS ≥2 points without worsening of fibrosis).
“Significantly more patients in the obeticholic acid arm (45%) versus placebo (21%) showed improved liver histology [46] (defined as decrease in NAS ≥2 points without worsening of fibrosis).”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [46]
In the FLINT trial, no statistically significant effect on the resolution of NASH was seen with obeticholic acid.
“Nevertheless, while the primary endpoint was reached, no statistically significant effect on the resolution of NASH was seen, which could limit direct clinical usefulness.”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [46]
Obeticholic acid was developed for MASH at 25 mg daily based on a phase II placebo-controlled trial showing improvement in fibrosis and liver enzymes after 18 months.
“The drug is approved at a 5 or 10 mg daily dose for second-line therapy in primary biliary cholangitis 379 and was developed for MASH at a higher dose (25 mg daily), based on a phase II placebo-controlled trial showing improvement in fi brosis and liver enzymes after 18 months of treatment.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [380]
In the FLINT trial, no effect of OCA was observed in patients with advanced fibrosis.
“Although patients treated with OCA showed a significant improvement in the NAFLD activity score (i.e., the primary histological outcome) and a significant decrease in liver fibrosis, NASH resolution occurred in only 22% of patients treated with OCA (without a statically significant effect compared to placebo), and no effect was observed in patients with advanced fibrosis.”
From Gut-pancreas-liver Axis as a target for treatment of NAFLD/NASH (2020) · cites this paper as [83]
Pruritus developed in 23% of patients on OCA without leading to drug discontinuation.
“Although OCA was generally well tolerated, concerns were raised by the occurrence of side effects such as pruritus, which developed in 23% of patients on OCA without leading to drug discontinuation, increased total serum cholesterol and low-density lipoprotein (LDL)-cholesterol levels and a modest, but significant, reduction in high-density lipoprotein (HDL)-cholesterol [83].”
From Gut-pancreas-liver Axis as a target for treatment of NAFLD/NASH (2020) · cites this paper as [83]
OCA increased total serum cholesterol and LDL-cholesterol levels.
“Although OCA was generally well tolerated, concerns were raised by the occurrence of side effects such as pruritus, which developed in 23% of patients on OCA without leading to drug discontinuation, increased total serum cholesterol and low-density lipoprotein (LDL)-cholesterol levels and a modest, but significant, reduction in high-density lipoprotein (HDL)-cholesterol [83].”
From Gut-pancreas-liver Axis as a target for treatment of NAFLD/NASH (2020) · cites this paper as [83]
OCA was generally well tolerated.
“Although OCA was generally well tolerated, concerns were raised by the occurrence of side effects such as pruritus, which developed in 23% of patients on OCA without leading to drug discontinuation, increased total serum cholesterol and low-density lipoprotein (LDL)-cholesterol levels and a modest, but significant, reduction in high-density lipoprotein (HDL)-cholesterol [83].”
From Gut-pancreas-liver Axis as a target for treatment of NAFLD/NASH (2020) · cites this paper as [83]
In the FLINT trial, patients treated with OCA showed a significant decrease in liver fibrosis.
“Although patients treated with OCA showed a significant improvement in the NAFLD activity score (i.e., the primary histological outcome) and a significant decrease in liver fibrosis, NASH resolution occurred in only 22% of patients treated with OCA (without a statically significant effect compared to placebo), and no effect was observed in patients with advanced fibrosis.”
From Gut-pancreas-liver Axis as a target for treatment of NAFLD/NASH (2020) · cites this paper as [83]
In the FLINT trial, NASH resolution occurred in only 22% of patients treated with OCA, without a statistically significant effect compared to placebo.
“Although patients treated with OCA showed a significant improvement in the NAFLD activity score (i.e., the primary histological outcome) and a significant decrease in liver fibrosis, NASH resolution occurred in only 22% of patients treated with OCA (without a statically significant effect compared to placebo), and no effect was observed in patients with advanced fibrosis.”
From Gut-pancreas-liver Axis as a target for treatment of NAFLD/NASH (2020) · cites this paper as [83]
In the FLINT trial, patients treated with OCA showed significant improvement in the NAFLD activity score.
“Although patients treated with OCA showed a significant improvement in the NAFLD activity score (i.e., the primary histological outcome) and a significant decrease in liver fibrosis, NASH resolution occurred in only 22% of patients treated with OCA (without a statically significant effect compared to placebo), and no effect was observed in patients with advanced fibrosis.”
From Gut-pancreas-liver Axis as a target for treatment of NAFLD/NASH (2020) · cites this paper as [83]
OCA caused a modest but significant reduction in HDL-cholesterol.
“Although OCA was generally well tolerated, concerns were raised by the occurrence of side effects such as pruritus, which developed in 23% of patients on OCA without leading to drug discontinuation, increased total serum cholesterol and low-density lipoprotein (LDL)-cholesterol levels and a modest, but significant, reduction in high-density lipoprotein (HDL)-cholesterol [83].”
From Gut-pancreas-liver Axis as a target for treatment of NAFLD/NASH (2020) · cites this paper as [83]
Obeticholic acid improved histological features of NASH and fibrosis in phase IIb clinical trials.
“OCA is a semisynthetic bile acid analogue that improved histological features of NASH and fibrosis in phase IIb clinical trials (35).”
From Development of an in vitro human liver system for interrogating nonalcoholic steatohepatitis (2016) · cites this paper as [35]
In the FLINT phase 2b trial, 25 mg obeticholic acid for 18 months improved NAFLD activity score and its individual components but did not result in significantly higher NASH resolution compared with placebo; a higher proportion of patients showed improved fibrosis by at least one stage.
“FLINT (phase 2b)77: 25 mg OCA for 18 months improved NAFLD activity score (predefined primary endpoint) and its individual components, but did not result in significantly higher NASH resolution (22 vs 13% compared with placebo); however, a higher proportion of patients (35 vs 19%) showed improved fibrosis (by at least one stage).”
From Novel therapeutic targets for cholestatic and fatty liver disease (2022) · cites this paper as [77]
OCA was validated in several clinical trials for its benefit in ameliorating NASH-induced liver fibrosis.
“Although OCA was validated in several clinical trials for its benefit in ameliorating NASH-induced liver fibrosis51,52, the response rate was 23%, far from satisfactory19,20.”
From SUMOylation inhibitors synergize with FXR agonists in combating liver fibrosis (2020) · cites this paper as [52]
Obeticholic acid has a high safety profile in NASH patients in the FLINT trial, with pruritus and serum lipid alterations as major adverse effects.
“OCA has a high safety profile in patients with NASH as demonstrated in the FLINT trial, with the major adverse effects being pruritus and alterations of serum lipid profiles144.”
From The gut microbiome and liver cancer: mechanisms and clinical translation (2017) · cites this paper as [144]
FXR-targeted therapies have potential to improve heart failure.
“Given the potential for NF-kB to cause cardiac hypertrophy independent of processes such as hypertension, this presents indirect evidence for the potential of FXR-targeted therapies to improve heart failure144,145.”
From Dietary metabolism, the gut microbiome, and heart failure (2019) · cites this paper as [144]
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- Authors
- Neuschwander-Tetri, B. A., Loomba, R., Sanyal, A. J., Lavine, J. E., Van Natta, M. L., Abdelmalek, M. F., Chalasani, N., Dasarathy, S., Diehl, A. M., Hameed, B., Kowdley, K. V., McCullough, A., Terrault, N., Clark, J. M., Tonascia, J., Brunt, E. M., Kleiner, D. E., & Doo, E.
- Affiliations
- University of California San Diego (US)
- Virginia Commonwealth University (US)
- Columbia University (US)
- Duke University (US)
- Indiana University Indianapolis (US)
- Case Western Reserve University (US)
- University of California, San Francisco (US)
- Virginia Mason Medical Center (US)
- Cleveland Clinic (US)
- Johns Hopkins University (US)
- Washington University in St. Louis (US)
- National Cancer Institute (US)
- National Institute of Diabetes and Digestive and Kidney Diseases (US)
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2015-03
- Volume
- 385
- Issue
- 9972
- Pages
- 956-965
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC4447192
- OpenAlex
- W2106768039
- Cited by
- 2,237
- References
- 30
- Citations by year
- 2026: 89 · 2025: 111 · 2024: 145 · 2023: 159 · 2022: 192 · 2021: 236 · 2020: 264 · 2019: 245 · 2018: 234 · 2017: 229 · 2016: 190 · 2015: 130 · 2014: 4
- FWCI
- 139.29
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (grants U01DK061718, U01DK061728, U01DK061731, U01DK061732, U01DK061734, U01DK061737, U01DK061738, U01DK061730, U01DK061713)
- National Center for Advancing Translational Sciences (NCATS) for NASH CRN Studies (grants UL1TR000439, UL1TR000436, UL1TR000006, UL1TR000448, UL1TR000100, UL1TR000004, UL1TR000423, and UL1TR000058)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Keywords
- obeticholic acid, nonalcoholic steatohepatitis, non-cirrhotic liver disease, bile acid derivatives, liver histopathology, liver fibrosis, alanine aminotransferase, treatment discontinuation
- MeSH terms
- Receptor, Farnesoid X-Activated, Administration, Oral, Chenodeoxycholic Acid, Double-Blind Method, Female, Humans, Cholesterol, HDL, Cholesterol, LDL, Liver, Liver Cirrhosis, Male, Middle Aged, Weight Loss, Treatment Outcome, Receptors, Cytoplasmic and Nuclear, Non-alcoholic Fatty Liver Disease
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