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RecruitingPhase 2NCT07303803

A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus

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

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

300 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

MASH - Metabolic Dysfunction-Associated SteatohepatitisT2DM (Type 2 Diabetes Mellitus)

Summary

This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Chiglitazar, a drug called Chiglitazar Placebo, and others for people with mash - metabolic dysfunction-associated steatohepatitis and t2dm (type 2 diabetes mellitus). The study is currently recruiting participants at 17 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChiglitazar Placebo

Chiglitazar Placebo 48mg/day

DRUGChiglitazar

Chiglitazar 48mg/day

DRUGvitamin E

Vitamin E 100mg/three times a day

DRUGPolyene Phosphatidyl choline

Polyene Phosphatidyl choline 456mg/three times a day

Locations(17)

Ditan Hospital of integrated traditional Chinese and Western Medicine Center

Beijing, Beijing Municipality, China

Southwest Hospital of Third Military Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Southern Hospital

Guangzhou, Guangdong, China

Wuhan Union Hospital of Huazhong University of Science and Technology

Wuhan, Hebei, China

Taihe Hospital

Shiyan, Hubei, China

Xiangya hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Jilin University

Changchun, Jilin, China

Renji hospital of Shanghai Jiao Tong University School of Medical

Shanghai, Shanghai Municipality, China

Ruijin Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine)

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07303803

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