A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type… (NCT07303803) | Clinical Trial Compass
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 1b 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.
Exclusion criteria
. Alcohol consumption \>20g ethyl alcohol/day for women and \>40g ethyl alcohol/day for men.
. Evidence of other forms of chronic liver disease:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with resolution of steatohepatitis and no worsening of liver fibrosis
Timeframe: week 72
Trial details
NCT IDNCT07303803
SponsorShanghai Jiao Tong University School of Medicine