New drug cocktail aims to reverse fatty liver damage in diabetics
NCT ID NCT07303803
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called chiglitazar, combined with anti-inflammatory and liver-protecting therapies, can improve liver health in people who have both MASH (a severe fatty liver disease) and type 2 diabetes. About 300 adults will receive either the drug combo or a placebo for several months. The main goal is to see if the treatment can resolve liver inflammation without worsening scarring.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Chiglitazar (a drug that targets metabolism and inflammation), vitamin E, and polyene phosphatidylcholine
- What this could lead to
- If successful, this combination could offer a new treatment option for people with both MASH and type 2 diabetes, potentially reducing liver inflammation and scarring.
- What could go wrong
- This is an early Phase 2 trial with only 300 participants, so results may not apply to everyone. The treatment involves multiple drugs, which could increase side effects or interactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent. 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\>8.5 kPa. 4. 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) 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: 1. Alcohol consumption \>20g ethyl alcohol/day for women and \>40g ethyl alcohol/day for men. 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 treatment targeting MASH for more than 2 weeks in the 3 months prior to screening (GLP-1 receptor agonists or PPAR pan agonists). 18. Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
17 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ditan Hospital of integrated traditional Chinese and Western Medicine Center
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100015, China
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Renji hospital of Shanghai Jiao Tong University School of Medical
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200001, China
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Ruijin Hospital of Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200020, China
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Shanghai Public Health Clinical Center
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200083, China
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Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine)
RECRUITINGShanghai, Shanghai Municipality, 200125, China
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Southern Hospital
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510515, China
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Southwest Hospital of Third Military Medical University
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 400038, China
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Taihe Hospital
NOT_YET_RECRUITINGShiyan, Hubei, 442000, China
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The First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITINGFuzhou, Fujian, 350005, China
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The First Affiliated Hospital of Jilin University
NOT_YET_RECRUITINGChangchun, Jilin, 130021, China
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The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITINGXi’an, Shanxi, 710061, China
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The First Affiliated Hospital of Zhejiang University
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310003, China
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The First Teaching Hospital of Xinjiang Medical University
NOT_YET_RECRUITINGÜrümqi, Xinjiang, 830054, China
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The Third Affiliated Hospital of Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510000, China
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Tianjin Second People's Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300192, China
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Wuhan Union Hospital of Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hebei, 430022, China
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Xiangya hospital of Central South University
NOT_YET_RECRUITINGChangsha, Hunan, 410008, China
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