Trial reportGastroenterology2019
Factors Associated With Histologic Response in Adult Patients With Nonalcoholic Steatohepatitis.
Trial report in Gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03914495 (The Role of Microbiome Reprogramming on Liver Fat Accumulation), which is not on this map. Cited by 60 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Role of Microbiome Reprogramming on Liver Fat Accumulation
Who cites it
60 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Efficacy and safety of efruxifermin for patients with NASH/MASH: an updated systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- KASL clinical practice guidelines for noninvasive tests to assess liver fibrosis in chronic liver disease.Clinical and molecular hepatology · 2024Guideline
- EASL-EASD-EASO Clinical Practice Guidelines on the Management of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).Obesity facts · 2024Guideline
- Efficacy and safety of semaglutide in non-alcoholic fatty liver disease.World journal of gastroenterology · 2023Pooled it
- Pilot trials of oral betaine in participants with metabolic dysfunction-associated steatotic liver disease and elevated alanine aminotransferase.Hepatology (Baltimore, Md.) · 2026Trial
- HTD1801 demonstrates promising potential for histologic improvements in metabolic dysfunction-associated steatohepatitis in both a preclinical and phase 2 study.Clinical and molecular hepatology · 2025Trial
- Lubiprostone Reduces Fat Content on MRI-PDFF in Patients With MASLD: A 48-Week Randomised Controlled Trial.Alimentary pharmacology & therapeutics · 2025Trial
- Exercise training improves serum biomarkers of liver fibroinflammation in patients with metabolic dysfunction-associated steatohepatitis.Liver international : official journal of the International Association for the Study of the Liver · 2024Trial
- ZSP1601, a novel pan-phosphodiesterase inhibitor for the treatment of NAFLD, A randomized, placebo-controlled phase Ib/IIa trial.Nature communications · 2023Trial
- Semaglutide 2·4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial.The lancet. Gastroenterology & hepatology · 2023Trial
- Serum Fibroblast Growth Factor 21 Is Markedly Decreased following Exercise Training in Patients with Biopsy-Proven Nonalcoholic Steatohepatitis.Nutrients · 2023Trial
- Randomised clinical trial: semaglutide versus placebo reduced liver steatosis but not liver stiffness in subjects with non-alcoholic fatty liver disease assessed by magnetic resonance imaging.Alimentary pharmacology & therapeutics · 2021Trial
- Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial.Nature medicine · 2021Trial
- Multicenter Validation of Association Between Decline in MRI-PDFF and Histologic Response in NASH.Hepatology (Baltimore, Md.) · 2020Trial
- Noninvasive surrogate endpoints in MASH trials: current perspectives and challenges.Hepatology international · 2026Review
- Metabolic dysfunction-associated steatotic liver disease assessment and management: Clinical practice guidance from the Canadian Association for the Study of the Liver.Canadian liver journal · 2026Article
- Pharmacological Therapy for Metabolic Dysfunction-Associated Steatotic Liver Disease in a New Era for Obesity and Metabolic Medicine: A State-of-the-Art Review.Journal of obesity & metabolic syndrome · 2026Review
- Review
- The Effect of GLP-1 Agonists on Patients with Metabolic-Associated Steatotic Liver Disease: A Systematic Review and Meta-Analysis.Pharmaceutics · 2026Review
- A six-gene prognostic signature for aflatoxin B1-associated hepatocellular carcinoma identified through integrated bioinformatics and network toxicology.Translational gastroenterology and hepatology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
BACKGROUND &
aimsNonalcoholic steatohepatitis (NASH) is a leading cause of liver transplantation, and many trials are underway to evaluate potential therapies. The farnesoid X receptor ligand obeticholic acid in the NASH treatment trial evaluated the effects of obeticholic acid vs placebo on histologic response (defined as decrease in nonalcoholic fatty liver disease activity score [NAS] by ≥2, with no worsening of fibrosis); 45% of patients had a histologic response to obeticholic acid (25 mg), and 21% had a response to placebo (P < .01). We performed a secondary analysis of data from this trial to identify clinical parameters associated with a histologic response.
methodsWe used a logistic regression model with a stepwise selection procedure to identify baseline and early on-treatment factors associated with a histologic response at 72 weeks. Baseline demographics, liver histology, medical history, concomitant medications, cardiometabolic parameters, and serum biochemistry, as well as the changes over the course of the trial (at weeks 12 and 24), were evaluated as potential predictors of a histologic response. The model was cross-validated by a jackknife method, and performance was evaluated with the area under the receiver operating characteristic curve.
resultsThe logistic regression model found that obeticholic acid treatment, baseline NAS > 5, baseline triglyceride level ≤ 154 mg/dL, baseline international normalized ratio ≤ 1, baseline aspartate aminotransferase level ≤ 49 U/L, and a decrease in alanine aminotransferase level at week 24 by 17 U/L or more, to be significantly associated with histologic response (area under the receiver operating characteristic curve, 0.83; 95% confidence interval, 0.77-0.89; P < .0001).
conclusionsIn a secondary analysis of data from a clinical trial of obeticholic acid in patients with NASH, we identified routine clinical and laboratory parameters during the first 24 weeks of treatment (such as baseline NAS, triglyceride levels, and a decrease in alanine aminotransferase level) to significantly associate with histologic markers of response.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.