A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus
CHIG-MASH
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
1 other identifier
interventional
300
1 country
17
Brief Summary
This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2026
Longer than P75 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2025
CompletedFirst Posted
Study publicly available on registry
December 26, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
January 5, 2026
December 1, 2025
4.9 years
December 11, 2025
December 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with resolution of steatohepatitis and no worsening of liver fibrosis
The definition of resolution of steatohepatitis was based on the following criteria: either a reduction in NAS score of at least 2 points or a post-treatment NAS score of 3 points or less; a minimum 1-point improvement in score for ballooning or inflammation
week 78
Secondary Outcomes (9)
Percentage of participants with an improvement in liver fibrosis by ≥ 1 stage (NASH CRN fibrosis score) and no worsening of steatohepatitis
week 78
Percentage of participants with resolution of steatohepatitis and improvement in liver fibrosis
week 78
Change in body mass index from baseline
Week 2, 6, 13, 26, 39, 52, 65, 78
Changes in liver stiffness values assessed by transient elastography from baseline
Week 2, 6, 13, 26, 39, 52, 65, 78
Change in CAP values assessed by transient elastography from baseline
Week 2, 6, 13, 26, 39, 52, 65, 78
- +4 more secondary outcomes
Study Arms (2)
Chiglitazar Placebo + vitamin E + polyene phosphatidyl choline
PLACEBO COMPARATORChiglitazar placebo given orally once a day
48mg Chiglitazar + vitamin E + polyene phosphatidyl choline
EXPERIMENTAL48mg Chiglitazar given orally once a day
Interventions
Chiglitazar 48mg/day
Vitamin E 100mg/three times a day
Chiglitazar Placebo 48mg/day
Polyene Phosphatidyl choline 456mg/three times a day
Eligibility Criteria
You may qualify if:
- Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent.
- Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.
- Participants must take Fibroscan examination with the result of CAP ≥ 238 dB/m and LSM\>8.5 kPa.
- Diagnosis of MASH by liver biopsy, with NAFLD Activity Score (NAS) ≥4 with ≥1 point for each component, and fibrosis stage 1 or more over according to the NASH Clinical Research Network (CRN) scoring system. (or liver biopsy not more than 6 months prior to screening)
- Stable body weight (≤10% body weight change) for at least 3 months.
- Possess good understanding and behavior and be able to take the medication daily as required by the trial.
- Willing to sign the informed consent.
You may not qualify if:
- Alcohol consumption \>20g ethyl alcohol/day for women and \>40g ethyl alcohol/day for men.
- Evidence of other forms of chronic liver disease:
- Alcoholic liver disease,
- Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,
- Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),
- Evidence of autoimmune liver disease as defined by compatible liver histology,
- Current drug-induced liver disease as defined on the basis of typical exposure and history,
- Suspected or proven liver cancer,
- Any other type of liver disease other than MASH.
- Uncontrolled T2DM defined as HbA1c \>9.5% at time of screening or Type 1 diabetes mellitus (T1DM).
- Patients with T2DM who have a history of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic maculopathy or severe non-proliferative diabetic retinopathy that requires acute treatment.
- Any of the following cardiovascular conditions within 6 months prior to screening:
- acute myocardial infarction (MI),
- cerebrovascular accident (stroke),
- unstable angina,
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Ditan Hospital of integrated traditional Chinese and Western Medicine Center
Beijing, Beijing Municipality, 100015, China
Southwest Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Southern Hospital
Guangzhou, Guangdong, 510515, China
Wuhan Union Hospital of Huazhong University of Science and Technology
Wuhan, Hebei, 430022, China
Taihe Hospital
Shiyan, Hubei, 442000, China
Xiangya hospital of Central South University
Changsha, Hunan, 410008, China
The First Affiliated Hospital of Jilin University
Changchun, Jilin, 130021, China
Renji hospital of Shanghai Jiao Tong University School of Medical
Shanghai, Shanghai Municipality, 200001, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200020, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200083, China
Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine)
Shanghai, Shanghai Municipality, 200125, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061, China
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, 300192, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hai Li, professor
Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Gastroenterology, Punan Campus, RenJi Hospital
Study Record Dates
First Submitted
December 11, 2025
First Posted
December 26, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
January 5, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share