Evidence mapPaperPMID 42150836Full record

ArticleBMJ open2026

Chiglitazar in combination with anti-inflammatory and hepatoprotective therapy for the treatment of MASH associated with T2DM: a prospective, multicentre, randomised, double-blind, placebo-controlled study protocol.

Kai He, Fengyuan Chen, Rong Shao, Wanjun Jiang, Wenyi Gu, Zeyu Huang, Yunxia Gan, Yan Wang, Hong Wu, Yunxin Zhao and 12 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07303803 (Chiglitazar in Combination With Anti-Inflammatory and Hepatoprotective Therapy for the Treatment in MASH Associated With T2DM), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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.

NCT07303803 phase2recruitingnot on this map

Chiglitazar in Combination With Anti-Inflammatory and Hepatoprotective Therapy for the Treatment in MASH Associated With T2DM: a Prospective, Multicentre, Randomised, Double-blind, Placebo-controlled Study

TypeinterventionalSponsorShanghai Jiao Tong University School of MedicineRan2026 to 2030Enrolled300ConditionsMASH - Metabolic Dysfunction-Associated Steatohepatitis, T2DM (Type 2 Diabetes Mellitus)ArmsChiglitazar Placebo, Chiglitazar, vitamin E, Polyene Phosphatidyl choline
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Kai HeDepartment of Gastroenterology, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.ORCID http://orcid.org/0009-0003-0572-2053
Fengyuan ChenDepartment of Gastroenterology, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Rong ShaoDepartment of Gastroenterology, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Wanjun JiangDepartment of Ultrasound, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Wenyi GuDepartment of Gastroenterology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Zeyu HuangDepartment of Endocrinology and Metabolism, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yunxia GanDepartment of Endocrinology and Metabolism, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yan WangDepartment of Endocrinology and Metabolism, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Hong WuDepartment of Endocrinology and Metabolism, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yunxin ZhaoDepartment of Ultrasound, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Bei ZhangDepartment of Ultrasound, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Lingling GaoClinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China.ORCID http://orcid.org/0000-0002-3526-6488
Xiaoyan YanClinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China.
Chen YaoClinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China.
Chaoyun ShenShenzhen Chipscreen Biosciences Co., Ltd, Shenzhen, Guangdong, China.
Peixuan JiDepartment of Gastroenterology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Jianyi WeiDepartment of Gastroenterology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yuexiang BianDepartment of Gastroenterology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yawen LuDepartment of Gastroenterology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Adila AbuduainiDepartment of Gastroenterology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Lianyong Liu *Department of Endocrinology and Metabolism, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China haili_17@126.com chinallu@163.com.
Hai Li *Department of Gastroenterology, Ren Ji Hospital, Punan Campus, School of Medicine, Shanghai Jiao Tong University, Shanghai, China haili_17@126.com chinallu@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMetabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), is the hepatic manifestation of the metabolic syndrome. When it co-occurs with type 2 diabetes (T2DM), it presents a significant therapeutic challenge due to a higher risk of fibrosis progression and adverse outcomes. While new treatments for MASH are emerging, their efficacy in the T2DM subpopulation remains an unmet need. Chiglitazar is a novel peroxisome proliferator-activated receptor pan-agonist that regulates key pathways in lipid metabolism, glucose homeostasis and inflammation. This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM. METHODS AND ANALYSIS: This is a prospective, multicentre, randomised, double-blind, placebo-controlled study. This trial will enrol 300 adult patients aged 18-75 years with biopsy-confirmed MASH and fibrosis stage F1 or higher. Participants will be randomised (1:1) to receive either chiglitazar 48 mg daily or a matching placebo. All participants will also receive background therapy consisting of vitamin E (100 mg three times a day) and polyene phosphatidyl choline (456 mg three times a day). The treatment duration is 78 weeks. The primary efficacy endpoint is resolution of steatohepatitis with no worsening of liver fibrosis. Key secondary endpoints include improvement in liver fibrosis by at least one stage and changes in metabolic and liver safety biomarkers. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Shanghai Punan Hospital of Pudong New District Ethics Committee (Punan Branch of Renji Hospital Ethics Committee, Shanghai Jiaotong University School of Medicine). KY2025-066. The findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: NCT07303803.

Indexed as

Anti-Inflammatory AgentsDiabetes Mellitus, Type 2Non-alcoholic Fatty Liver DiseasePhenylpropionatesAdolescentAdultAgedChalconesDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPropionatesAnti-Inflammatory AgentsChalconeselifibranorPhenylpropionatesPropionatesBiopsyDiabetes Mellitus, Type 2Randomized Controlled Trial

Identifiers

PMID42150836
PMCPMC13185019

What Socratic holds

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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.