Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID07303803

Chiglitazar in Combination With Anti-Inflammatory and Hepatoprotective Therapy for MASH Associated With Type 2 Diabetes Mellitus: A Randomised, Double-blind, Placebo-controlled Study

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-06-03

300

Participants Needed

17

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Shanghai Jiao Tong University School of Medicine

Lead Sponsor

C

Chipscreen Biosciences, Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for adults with metabolic dysfunction-associated steatohepatitis (MASH) and type 2 diabetes mellitus (T2DM). MASH, formerly known as non-alcoholic steatohepatitis (NASH), is a liver condition linked to metabolic syndrome and presents heightened risks when combined with T2DM. This trial focuses on addressing the unmet need for effective treatments in this specific patient population. The study is a prospective, multicenter, randomized, double-blind, placebo-controlled trial enrolling 300 adults aged 18 to 75 years with biopsy-confirmed MASH and fibrosis stage 1b or higher. Participants will be randomized to receive either 48 mg of chiglitazar daily or a matching placebo. All participants will also receive background therapy with vitamin E (100 mg three times daily) and polyene phosphatidylcholine (456 mg three times daily). Treatment will continue for 72 weeks. Participants will undergo assessments including liver biopsies, Fibroscan examinations, and blood tests at baseline and throughout the study. Researchers will measure the percentage of participants achieving resolution of steatohepatitis without worsening liver fibrosis at week 72 as the primary outcome. Secondary outcomes include liver fibrosis improvement, changes in body mass index, liver stiffness, liver fat content, blood sugar control (HbA1c), lipid levels, liver function, and MRI-based liver fat measurements. Safety and metabolic biomarkers will be monitored closely during the trial period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 to 75 years at the time of consent
  • Diagnosed with type 2 diabetes mellitus with HbA1c of 9.5% or less at screening
  • Fibroscan results showing CAP of 238 dB/m or higher and liver stiffness measurement over 8.5 kPa
  • Liver biopsy confirming metabolic dysfunction-associated steatohepatitis with NAS score of 4 or more and fibrosis stage 1b or higher
  • Stable body weight with 10% or less change for at least 3 months
  • Able to understand and take medication daily as required
  • Willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Alcohol consumption over 20g per day for women or over 40g per day for men
  • Other chronic liver diseases such as alcoholic liver disease, hepatitis B or C, autoimmune liver disease, drug-induced liver disease, liver cancer, or any liver disease other than MASH
  • Uncontrolled type 2 diabetes with HbA1c over 9.5% or diagnosis of type 1 diabetes
  • History of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy requiring acute treatment
  • Cardiovascular events within 6 months before screening including heart attack, stroke, unstable angina, heart failure hospitalization, or severe heart failure
  • Active or untreated cancer or remission of clinically significant cancer less than 5 years
  • Uncontrolled high blood pressure (systolic ≥160 mm Hg or diastolic ≥100 mm Hg)
  • Severe kidney impairment with eGFR below 30 mL/min/1.73 m2
  • Significant gastric emptying problems or chronic use of drugs affecting gastrointestinal motility
  • Personal or family history of multiple endocrine neoplasia type 2, thyroid C-cell hyperplasia, or medullary thyroid carcinoma
  • Untreated thyroid disorders
  • Organ transplant recipients or awaiting transplant (except corneal)
  • Pregnancy, breastfeeding, or unwillingness to use effective birth control
  • Recent use of drugs causing liver fat or weight gain, systemic steroids, or treatments targeting MASH within 3 months
  • Any condition that may prevent compliance or study completion according to investigator's opinion

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 72 weeks

Participants take either Chiglitazar 48 mg daily or placebo, alongside vitamin E and polyene phosphatidylcholine, to evaluate the efficacy and safety of the combination therapy for metabolic dysfunction-associated steatohepatitis and type 2 diabetes mellitus.

Scheduled visits at Week 4, 8, 12, 24, 36, 48, 60, and 72 for assessments

Trial Site Locations

Total: 17 locations

1

Ditan Hospital of integrated traditional Chinese and Western Medicine Center

Beijing, Beijing Municipality, China, 100015

Not Yet Recruiting

2

Southwest Hospital of Third Military Medical University

Chongqing, Chongqing Municipality, China, 400038

Not Yet Recruiting

3

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350005

Not Yet Recruiting

4

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510000

Not Yet Recruiting

5

Southern Hospital

Guangzhou, Guangdong, China, 510515

Not Yet Recruiting

6

Wuhan Union Hospital of Huazhong University of Science and Technology

Wuhan, Hebei, China, 430022

Not Yet Recruiting

7

Taihe Hospital

Shiyan, Hubei, China, 442000

Not Yet Recruiting

8

Xiangya hospital of Central South University

Changsha, Hunan, China, 410008

Not Yet Recruiting

9

The First Affiliated Hospital of Jilin University

Changchun, Jilin, China, 130021

Not Yet Recruiting

10

Renji hospital of Shanghai Jiao Tong University School of Medical

Shanghai, Shanghai Municipality, China, 200001

Not Yet Recruiting

11

Ruijin Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200020

Not Yet Recruiting

12

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China, 200083

Not Yet Recruiting

13

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

Shanghai, Shanghai Municipality, China, 200125

Actively Recruiting

14

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China, 710061

Not Yet Recruiting

15

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China, 300192

Not Yet Recruiting

16

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China, 830054

Not Yet Recruiting

17

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China, 310003

Not Yet Recruiting

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Research Team

H

Hai Li, professor

L

Lianyong Liu, professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Kai He, Fengyuan Chen, Rong Shao...

https://pubmed.ncbi.nlm.nih.gov/42150836