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

NCT07303803 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-05

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Chipscreen Biosciences, Ltd.

    collaborator INDUSTRY

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Hai Li, professor · Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2030-12-01
Completion
2030-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07303803 on ClinicalTrials.gov