Evidence map›Paper›PMID 40467095›Full record

Trial reportBMJ (Clinical research ed.)2025

Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial.

Jiayang Lin, Yan Huang, Bingyan Xu, Xuejiang Gu, Junlin Huang, Jia Sun, Lijing Jia, Jiang He, Chensihan Huang, Xueyun Wei and 17 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03723252 (Efficacy and Safety of Dapagliflozin in Non-alcoholic Steatohepatitis), which is not on this map. Cited by 60 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT03723252 phase3completednot on this map

Efficacy and Safety of Dapagliflozin in Non-alcoholic Steatohepatitis: a Multicentre, Randomized, Placebo-controlled Trial

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2019 to 2024Enrolled154ConditionsNonalcoholic SteatohepatitisArmsDapagliflozin, Placebo
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  10. DGAT2 inhibition in MASH: histologic promise and lipid paradox.Hepatobiliary surgery and nutrition · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Jiayang LinDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Yan HuangDepartment of Food Safety and Health Research Centre, School of Public Health, Southern Medical University, Guangzhou, China.
Bingyan XuDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Xuejiang GuDepartment of Endocrinology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Junlin HuangDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Jia SunDepartment of Endocrinology and metabolism, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
Lijing JiaDepartment of Endocrinology, Shenzhen People's Hospital, Shenzhen, China.
Jiang HeDepartment of Epidemiology, Peter O'Donnell Jr School of Public Health, UT Southwestern Medical Center, Dallas, TX, USA.
Chensihan HuangDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Xueyun WeiDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Jinjun ChenHepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Xiaomin ChenDepartment of Endocrinology, Zhongshan Hospital of Xiamen University, Xiamen, China.
Jingping ZhouDepartment of Gastroenterology, Zhongshan Hospital of Xiamen University, Xiamen, China.
Lixian WuDepartment of Infectious Diseases, First People's Hospital of Foshan, Foshan, China.
Peizhen ZhangDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China huijiezhang2005@126.com.
Yaxin ZhuDepartment of Endocrinology, Shenzhen People's Hospital, Shenzhen, China.
Huimin XiaDepartment of Endocrinology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Ge WenMedical Imaging Centre, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Yating LiuDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Shiqun LiuDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Yanmei ZengDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Lin ZhouDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Hongxia JiaDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Hua HeDepartment of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.
Yaoming XueDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Fenglin WuDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Huijie ZhangDepartment of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China huijiezhang2005@126.com.ORCID 0000-0003-0640-0315

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor dapagliflozin in participants with metabolic dysfunction-associated steatohepatitis (MASH).

designMulticentre, double blind, randomised, placebo controlled trial.

settingSix tertiary hospitals in China from 23 November 2018 to 28 March 2023.

participants154 adults with biopsy diagnosed MASH, with or without type 2 diabetes.

interventionsAll participants were randomly assigned to receive 10 mg orally of dapagliflozin or matching placebo once daily for 48 weeks.

main outcome measuresThe primary endpoint was MASH improvement (defined as a decrease of at least 2 points in non-alcoholic fatty liver disease activity score (NAS) or a NAS of ≤3 points) without worsening of liver fibrosis (defined as without increase of fibrosis stage) at 48 weeks. The secondary endpoints included the MASH resolution without worsening of fibrosis and fibrosis improvement without worsening of MASH. Analyses used the intention-to-treat dataset.

resultsMASH improvement without worsening of fibrosis was reported in 53% (41/78) of participants in the dapagliflozin group and 30% (23/76) in the placebo group (risk ratio 1.73 (95% confidence interval (CI) 1.16 to 2.58); P=0.006). Mean difference of NAS was -1.39 (95% CI -1.99 to -0.79); P<0.001). MASH resolution without worsening of fibrosis occurred in 23% (18/78) of participants in the dapagliflozin group and 8% (6/76) in the placebo group (risk ratio 2.91 (95% CI 1.22 to 6.97); P=0.01). Fibrosis improvement without worsening of MASH was reported in 45% (35/78) of participants in the dapagliflozin group, as compared with 20% (15/76) in the placebo group (risk ratio 2.25 (95% CI 1.35 to 3.75); P=0.001). The percentage of individuals who discontinued treatment because of adverse events was 1% (1/78) in the dapagliflozin group and 3% (2/76) in the placebo group.

conclusionTreatment with dapagliflozin resulted in a higher proportion of participants with MASH improvement without worsening of fibrosis, as well as MASH resolution without worsening of fibrosis and fibrosis improvement without worsening of MASH, than with placebo.

trial registrationClinicalTrials.gov NCT03723252.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesNon-alcoholic Fatty Liver DiseaseSodium-Glucose Transporter 2 InhibitorsAdultChinaDouble-Blind MethodFemaleHumansLiver CirrhosisMaleMiddle AgedTreatment OutcomeBenzhydryl CompoundsdapagliflozinGlucosidesSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID40467095
PMCPMC12135075

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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 Socratic graph.