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MASH - Metabolic Dysfunction-Associated SteatohepatitisPhase 2CHIG-MASHNCT07303803

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

A Phase 2 study testing Chiglitazar, vitamin E and Polyene Phosphatidyl choline in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis and T2DM (Type 2 Diabetes Mellitus), run by Shanghai Jiao Tong University School of Medicine at 17 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
What is being tested?
Chiglitazar, vitamin E and Polyene Phosphatidyl choline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
17 sitesChina
Study dates
1 Jan 2026to 1 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 30Show fewer
  • 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.
  • Use of drugs associated with hepatic steatosis (e.g., amiodarone, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening.
  • 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.
  • Receiving or having received (within 3 months of screening) chronic (>2 weeks) systemic glucocorticoid therapy.
  • Use of treatment targeting MASH for more than 2 weeks in the 3 months prior to screening (GLP-1 receptor agonists or PPAR pan agonists).
  • Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hai Li, professor contact

+86 13818525494

haili_17@126.com

Lianyong Liu, professor contact

+86 13564144866

chinallu@163.com

17 sites in 1 country

China17 sites, 17 recruiting

  • Ditan Hospital of integrated traditional Chinese and Western Medicine Center

    Beijing, Beijing Municipality, 100015

    Not yet recruiting

  • The First Affiliated Hospital of Jilin University

    Changchun, Jilin, 130021

    Not yet recruiting

  • Xiangya hospital of Central South University

    Changsha, Hunan, 410008

    Not yet recruiting

  • Southwest Hospital of Third Military Medical University

    Chongqing, Chongqing Municipality, 400038

    Not yet recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Not yet recruiting

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Not yet recruiting

  • Southern Hospital

    Guangzhou, Guangdong, 510515

    Not yet recruiting

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310003

    Not yet recruiting

  • Renji hospital of Shanghai Jiao Tong University School of Medical

    Shanghai, Shanghai Municipality, 200001

    Not yet recruiting

  • Ruijin Hospital of Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200020

    Not yet recruiting

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality, 200083

    Not yet recruiting

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

    Shanghai, Shanghai Municipality, 200125

    Recruiting

  • Taihe Hospital

    Shiyan, Hubei, 442000

    Not yet recruiting

  • Tianjin Second People's Hospital

    Tianjin, Tianjin Municipality, 300192

    Not yet recruiting

  • The First Teaching Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

    Not yet recruiting

  • Wuhan Union Hospital of Huazhong University of Science and Technology

    Wuhan, Hebei, 430022

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi’an, Shanxi, 710061

    Not yet recruiting

Other trials in China

About this study

Official title: Chiglitazar in Combination With Anti-Inflammatory and Hepatoprotective Therapy for the Treatment in MASH Associated With T2DM: a Prospective, Multicentre, Randomised, Double-blind, Placebo-controlled Study

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

Read the detailed description

Metabolic dysfunction-associated steatohepatitis (MASH), used to be called non-alcoholic steatohepatitis (NASH), is a manifestation of the metabolic syndrome in the liver, particularly when co-occurring with type 2 diabetes (T2DM), presents a significant therapeutic challenge due to a higher risk of fibrosis progression and adverse outcomes. While new treatments for MASH are emerging, their efficacy in the T2DM subpopulation remains an area of unmet need. Chiglitazar is a novel peroxisome proliferator-activated receptor (PPAR) pan-agonist that regulates key pathways in lipid metabolism, glucose homeostasis, and inflammation. This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.

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 F1b 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 72 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.

Being tested
Chiglitazar Placebo, Chiglitazar, vitamin E, Polyene Phosphatidyl choline
Keywords
chiglitazar, metabolic dysfunction-associated steatohepatitis, type 2 diabetes, liver biopsy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chiglitazar PlaceboDrug

    Also called simulant of chiglitazar

    Chiglitazar Placebo 48mg/day

  • ChiglitazarDrug

    Also called Carfloglitazar

    Chiglitazar 48mg/day

  • vitamin EDrug

    Also called Laiyi

    Vitamin E 100mg/three times a day

  • Polyene Phosphatidyl cholineDrug

    Also called Yi Shan Fu

    Polyene Phosphatidyl choline 456mg/three times a day

Study groups in NCT07303803
Study groupRoleWhat they receive
Chiglitazar Placebo + vitamin E + polyene phosphatidyl cholinePlacebo comparatorChiglitazar placebo given orally once a day
Receives: Drug: Chiglitazar Placebo; Drug: vitamin E; Drug: Polyene Phosphatidyl choline
48mg Chiglitazar + vitamin E + polyene phosphatidyl cholineExperimental48mg Chiglitazar given orally once a day
Receives: Drug: Chiglitazar; Drug: vitamin E; Drug: Polyene Phosphatidyl choline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The definition of resolution of steatohepatitis was based on the following criteria: ballooning=0, inflammation=0,1 and any level of steatosis in NAS

    Measured: week 72

Secondary outcomes (10)

  1. Percentage of participants with an improvement in liver fibrosis by ≥ 1 stage (NASH CRN fibrosis score) and no worsening of steatohepatitis

    Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, participants were evaluated with the NASH CRN scoring system with ≥1-point reduction without worsening of MASH (defined as no increase in the NAS score).

    Measured: week 72

  2. Percentage of participants with resolution of steatohepatitis and improvement in liver fibrosis

    Participants were evaluated with the NASH CRN scoring system with ≥1-point reduction and with resolution of steatohepatitis

    Measured: week 72

  3. Change in body mass index from baseline

    The body mass index = weight (kg) / height (m)².

    Measured: Week 4, 8, 12, 24, 36, 48, 60, 72

  4. Changes in liver stiffness values assessed by transient elastography from baseline

    Measured by Fibroscan, to evlaute the severity of liver fibrosis

    Measured: Week 4, 8, 12, 24, 36, 48, 60, 72

  5. Change in CAP values assessed by transient elastography from baseline

    Measured by Fibroscan, to evlaute the severity of liver fat

    Measured: Week 4, 8, 12, 24, 36, 48, 60, 72

  6. Change in HbA1c from baseline

    Central lab test

    Measured: Week 4, 8, 12, 24, 36, 48, 60, 72

  7. Changes in blood fasting plasma glucose level from baseline

    Central lab test

    Measured: Week 4, 8, 12, 24, 36, 48, 60, 72

  8. Changes of blood lipids level from baseline

    Includeing TC, LDL-C, HDL-C, VLDL-C, non-HDL-C, TG

    Measured: Week 4, 8, 12, 24, 36, 48, 60, 72

  9. Changes of liver function from baseline

    Includeing AST, ALT, GGT, AKP

    Measured: Week 4, 8, 12, 24, 36, 48, 60, 72

  10. Changes of MRI-PDFF from baseline

    magnetic resonance imaging-proton density fat fraction

    Measured: Week 4, 8, 12, 24, 36, 48, 60, 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study start1 Jan 2026
  3. Primary completion1 Dec 2030 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07303803
Sponsor's protocol ID
KS2540
Acronym
CHIG-MASH
Status last verified
Jun 2026
First submitted
11 Dec 2025
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • He K, Chen F, Shao R, Jiang W, Gu W, Huang Z, Gan Y, Wang Y, Wu H, Zhao Y, Zhang B, Gao L, Yan X, Yao C, Shen C, Ji P, Wei J, Bian Y, Lu Y, Abuduaini A, Liu L, Li H. Chiglitazar in combination with anti-inflammatory and hepatoprotective therapy for the treatment of MASH associated with T2DM: a prospective, multicentre, randomised, double-blind, placebo-controlled study protocol. BMJ Open. 2026 May 18;16(5):e116945. doi: 10.1136/bmjopen-2026-116945.

    PubMed 42150836

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chiglitazar, vitamin E and Polyene Phosphatidyl choline in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis and T2DM (Type 2 Diabetes Mellitus), run by Shanghai Jiao Tong University School of Medicine at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hai Li, professor (+86 13818525494, haili_17@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with resolution of steatohepatitis and no worsening of liver fibrosis (time frame: week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07303803, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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