Beijing CapitalBio Jingfang Biotech Co., Ltd.
Conditions
Interventions
experimental group:(1) Basic Treatment: Scientific dietary and exercise guidance. All patients shall receive diet control and exercise in strict accordance with the recommendations in the Guidelines f
Sponsors
Beijing Tsinghua Changguang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Able to understand and voluntarily sign a written informed consent form in compliance with GCP requirements. (2) Aged between 18 and 65 years inclusive, with no gender restriction. (3) CAP = 268 dB/m and 8 kPa 90 cm (males) / 80 cm (females); 2) Fasting plasma glucose = 5.6 mmol/L, or 2-hour postprandial glucose = 7.8 mmol/L, or HbA1c = 5.7%, or a diagnosis of type 2 diabetes mellitus / receiving treatment for type 2 diabetes mellitus; 3) Blood pressure = 130/85 mmHg, or receiving specific antihypertensive medication; 4) Plasma triglycerides = 1.70 mmol/L, or receiving lipid-lowering treatment; 5) Plasma high-density lipoprotein cholesterol = 1.0 mmol/L (males) and = 1.3 mmol/L (females), or receiving lipid-lowering treatment.
Exclusion criteria
Exclusion criteria: 1. Have a medical history or evidence of any acute or chronic liver disease other than MASLD, including but not limited to viral hepatitis, alcoholic liver disease, autoimmune liver disease, inherited metabolic liver disease, etc. 2. Diagnosis of liver cirrhosis, decompensated liver disease, or hepatocellular carcinoma. 3. Current or previous heavy alcohol consumption (defined as an average alcohol intake of >30 g/day for males and >20 g/day for females over a continuous period of more than 3 months), or inability to abstain from alcohol from 48 hours prior to the first dose until the end of the study. 4. Complicated with severe primary diseases of the cardiovascular, cerebrovascular, renal, hematopoietic systems, etc., or patients with psychiatric disorders. 5. Persons with known allergy to any of the study drug components or with allergic constitution. 6. Type 1 diabetes mellitus, or type 2 diabetes mellitus with poor glycemic control (HbA1c = 8.0%). 7. Persons with cognitive impairment who cannot provide adequate informed consent. 8. Participation in another interventional clinical study within 30 days prior to screening. 9. Patients with a history of drug abuse. 10. Presence of severe abnormalities in vital signs or laboratory tests at screening, including but not limited to: platelet count 1.5; alanine aminotransferase or aspartate aminotransferase > 5.0 × ULN; total bilirubin > 1.5 × ULN (> 3.0 × ULN for Gilbert's syndrome); and other conditions that may interfere with the evaluation of study efficacy and safety and are deemed ineligible by the investigator. 11. Pregnant women, lactating women, or males/females planning to conceive in the near future. 12. Patients who have used traditional Chinese medicine within the past 2 weeks. 13.Participants deemed ineligible for this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Controlled Attenuation Parameter (CAP); Liver Stiffness Measurement (LSM); liver enzymes (ALT, AST);blood lipid parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;laboratory examinations;physical examination;adverse events; | — |
Countries
China
Contacts
Public ContactYang Ming
Beijing Tsinghua Changguang Hospital
Outcome results
None listed