NCT07303803

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Metabolic dysfunction-associated steatohepatitis (MASH), used to be called non-alcoholic steatohepatitis (NASH), is a manifestation of the metabolic syndrome in the liver, particularly when co-occurring with type 2 diabetes (T2DM), 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 area of unmet need. Chiglitazar is a novel peroxisome proliferator-activated receptor (PPAR) 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. This is a prospective, multicentre, randomised, double-blind, placebo-controlled study. The trial will enroll 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 phosphatidylcholine (456 mg three times a day). The treatment duration is 78 weeks. The primary efficacy endpoint is the 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.

Conditions

• MASH - Metabolic Dysfunction-Associated Steatohepatitis
• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
DRUG	Chiglitazar Placebo	Chiglitazar Placebo 48mg/day
DRUG	Chiglitazar	Chiglitazar 48mg/day
DRUG	vitamin E	Vitamin E 100mg/three times a day
DRUG	Polyene Phosphatidyl choline	Polyene Phosphatidyl choline 456mg/three times a day

Timeline

• Start date: 2026-01-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-12-26
• Last updated: 2026-01-05

Locations

17 sites across 1 country: China