A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus
NCT ID: NCT07303803
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2026-01-01
2030-12-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Chiglitazar Placebo + vitamin E + polyene phosphatidyl choline
Chiglitazar placebo given orally once a day
Chiglitazar Placebo
Chiglitazar Placebo 48mg/day
vitamin E
Vitamin E 100mg/three times a day
Polyene Phosphatidyl choline
Polyene Phosphatidyl choline 456mg/three times a day
48mg Chiglitazar + vitamin E + polyene phosphatidyl choline
48mg Chiglitazar given orally once a day
Chiglitazar
Chiglitazar 48mg/day
vitamin E
Vitamin E 100mg/three times a day
Polyene Phosphatidyl choline
Polyene Phosphatidyl choline 456mg/three times a day
Interventions
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Chiglitazar Placebo
Chiglitazar Placebo 48mg/day
Chiglitazar
Chiglitazar 48mg/day
vitamin E
Vitamin E 100mg/three times a day
Polyene Phosphatidyl choline
Polyene Phosphatidyl choline 456mg/three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.
3. Participants must take Fibroscan examination with the result of CAP ≥ 238 dB/m and LSM\>8 kPa.
4. Diagnosis of MASH by liver biopsy, with NAFLD Activity Score (NAS) ≥4 with ≥1 point for each component, and fibrosis stage 2 or more over according to the NASH Clinical Research Network (CRN) scoring system. (or liver biopsy not more than 6 months prior to screening)
5. Stable body weight (≤10% body weight change) for at least 3 months.
6. Possess good understanding and behavior and be able to take the medication daily as required by the trial.
7. Willing to sign the informed consent.
Exclusion Criteria
2. Evidence of other forms of chronic liver disease:
1. Alcoholic liver disease,
2. Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,
3. Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),
4. Evidence of autoimmune liver disease as defined by compatible liver histology,
5. Current drug-induced liver disease as defined on the basis of typical exposure and history,
6. Suspected or proven liver cancer,
7. Any other type of liver disease other than MASH.
3. Uncontrolled T2DM defined as HbA1c \>9.5% at time of screening or Type 1 diabetes mellitus (T1DM).
4. 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.
5. Any of the following cardiovascular conditions within 6 months prior to screening:
1. acute myocardial infarction (MI),
2. cerebrovascular accident (stroke),
3. unstable angina,
4. hospitalization due to congestive heart failure (CHF)
5. New York Heart Association Functional Classification IV CHF
6. 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.
7. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg).
8. Renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2.
9. Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility.
10. 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).
11. Evidence of untreated hypothyroidism or hyperthyroidism based on clinical or laboratory evaluation.
12. A transplanted organ (corneal transplants allowed) or awaiting an organ transplant.
13. 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.
14. Use of drugs associated with hepatic steatosis (e.g., amiodarone, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening.
15. Current use of medication is associated with weight gain, except when on stable dose for at least 3 months prior to screening and remaining on stable dose during the study.
16. Receiving or having received (within 3 months of screening) chronic (\>2 weeks) systemic glucocorticoid therapy.
17. Use of medications or alternative remedies (within 3 months prior to screening; prescribed or over-the-counter) intended to promote weight loss.
18. Use of treatment targeting MASH for more than 2 weeks in the 3 months prior to screening (GLP-1 receptor agonists, TZD analogues or PPAR pan agonists).
19. Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.
18 Years
75 Years
ALL
No
Sponsors
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Chipscreen Biosciences, Ltd.
INDUSTRY
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Hai Li
Professor, Department of Gastroenterology, Punan Campus, RenJi Hospital ;
Principal Investigators
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Hai Li, professor
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, Punan Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Locations
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Ditan Hospital of integrated traditional Chinese and Western Medicine Center
Beijing, Beijing Municipality, China
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
Punan Campus, renji hospital of Shanghai Jiao Tong University School of Medical
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
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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KS2540
Identifier Type: -
Identifier Source: org_study_id