Non-alcoholic fatty liver disease (NAFLD)
Conditions
Interventions
Experimental group:Polyethylene Glycol Recombinant Human Growth Hormone
Control group:Polyethylene Glycol Recombinant Human Growth Hormone Blank Vehicle
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form before the start of activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial; 2. Subjects diagnosed with NAFLD by imaging or liver biopsy who have received diet and exercise therapy for 3 months; 3. Aged 18-65 years, no gender limit; 4. The CAP value assessed by Fibroscan is >=320 dB/m and <=390 dB/m; 5. LSM < 13 KPa as assessed by Fibroscan; 6. BMI 24-30 kg/m^2; 7. IGF-1 SDS < 0; 8. If the subject has T2DM, HbA1c should be <8%, and should take a stable dose of anti-diabetic drugs for at least 3 months before screening.
Exclusion criteria
Exclusion criteria: 1. General situation: (1) Weekly alcohol consumption within 1 year before screening: men > 21 units (about 210g) alcohol, women > 14 units (about 140g) alcohol (1 unit of alcohol = 375ml of beer with 3.5% alcohol content or 30ml of spirits with 40% alcohol content or 100ml of red wine with 13.5% alcohol content); (2) Weight loss >=5% within 3 months before screening; (3) The investigator suspects that the subject may be allergic or intolerant to the study drug; (4) Pregnant or planning pregnancy or women of childbearing age, male subjects and their spouses are unwilling to use medically recognized contraceptive measures; (5) Lactating subjects; (6) The subject cannot meet the specific program requirements (such as regular visits, the subject cannot fully understand and complete the subject's research documents, the subject cannot or is unwilling to self-inject at home, etc.); (7) The researcher believes that the subjects have any factors (medical, psychological, social or geographical factors) that may affect the evaluation of the efficacy and safety of this study or cause them to fail to participate in the study successfully; 2. Use of any of the following drugs or treatments prior to screening: (1) Have used drugs with weight control effect or performed surgery that can lead to weight instability within 2 months before screening, or are currently in a weight loss plan and are not in the maintenance phase; (2) Received long-term (more than 7 consecutive days) administration of glucocorticoids and sex hormones within 2 months before screening (excluding topical skin administration and intraocular administration); (3) Have used growth hormone or growth hormone-releasing hormone therapy within one year before screening; (4) Participated in any clinical trials of drugs or medical devices within 3 months before screening (only signed informed consent, except for those who have not received any drug or device intervention); (5) According to the judgment of the investigator, any drug that may interfere with the interpretation of efficacy and safety data has been used within 2 months before screening (such as receiving vitamin E, pioglitazone, GLP-1 receptor agonists, obeticholic acid, ursodeoxycholic acid, insulin, etc.), or using any drugs known to have common toxicity to major organs; 3. History or evidence of any of the following diseases before screening: (1) Chronic liver disease caused by other factors: drug-induced hepatitis, viral hepatitis, autoimmune hepatitis, hepatolenticular degeneration, primary biliary cirrhosis, primary sclerosing cholangitis, noxious hyperpigmentation, alpha-1 antitrypsin deficiency, Wilson's disease (Wilsons disease), inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, beta-lipoprotein deficiency, lipid-atrophic diabetes mellitus, Mauriac syndrome; (2) Liver cirrhosis meets any of the following criteria: 1) Liver cirrhosis confirmed by previous liver biopsy; 2) Liver imaging (ultrasound, CT or MRI) suggests liver cirrhosis, including nodule formation on the liver surface, splenomegaly, and portal vein collateral circulation; 3) History of decompensated chronic liver disease, including ascites, hepatic encephalopathy or variceal bleeding; (3) Acute or chronic infection occurs within 1 month before screening, and the investigator believes that it may affect the health of the subjects or the safety in the trial; (4) Received blood transfusion within 2 months befo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fat content determination controlled attenuation parameter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver stiffness value;Cytokeratin CK-18 (M30 and M65);Serum hepatic fibrosis biotype III collagen N-terminal propeptide;Visceral fat content ;Weight;Waist circumference;Hips circumference;Waist to hip ratio;Fasting insulin;Insulin resistance index;Lipid profile (triglycerides, LDL, HDL, cholesterol);Blood pressure;Liver function (ALT, AST, GGT);Insulin growth factor-1 absolute value and SDS;Fat content determination controlled attenuation parameter relative change; | — |
Countries
China
Contacts
Public ContactQu Shen
Outcome results
None listed