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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: MASH - Metabolic Dysfunction-Associated Steatohepatitis, T2DM (Type 2 Diabetes Mellitus)

In brief

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

Key facts

Study ID

NCT07303803

Run by

Shanghai Jiao Tong University School of Medicine

People needed

300

Starts

2026-01-01

Expected to finish

2030-12-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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),
• Evidence of autoimmune liver disease as defined by compatible liver histology,
• Current drug-induced liver disease as defined on the basis of typical exposure and history,
• Suspected or proven liver cancer,
• Any other type of liver disease other than MASH.
• Uncontrolled T2DM defined as HbA1c >9.5% at time of screening or Type 1 diabetes mellitus (T1DM).
• Patients with T2DM who have a history of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic maculopathy or severe non-proliferative diabetic retinopathy that requires acute treatment.
• Any of the following cardiovascular conditions within 6 months prior to screening:
• acute myocardial infarction (MI),
• cerebrovascular accident (stroke),
• unstable angina,
• hospitalization due to congestive heart failure (CHF)
• New York Heart Association Functional Classification IV CHF
• History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
• Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg).
• Renal impairment measured as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.
• Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility.
• Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).
• Evidence of untreated hypothyroidism or hyperthyroidism based on clinical or laboratory evaluation.
• A transplanted organ (corneal transplants allowed) or awaiting an organ transplant.
• Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial (at least include one barrier contraceptive method) and breast feeding.

Where it is running

• Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine) — Shanghai, Shanghai Municipality, China (enrolling)
• 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
• 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
• Ditan Hospital of integrated traditional Chinese and Western Medicine Center — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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