Not Yet RecruitingPhase 2

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

China300 participantsStarted 2026-01-01

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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),

Percentage of participants with resolution of steatohepatitis and no worsening of liver fibrosis

Timeframe: week 78

NCT IDNCT07303803

SponsorShanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-01

Hai Li, professor

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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),