HuHuangLianzonggan Capsule in Subjects With Nonalcoholic Steatohepatitis: a Phase 2 tRial(HHL-HEPAR)

Inclusion Criteria:

1. Males and females between 18-75 years of age inclusive(including boundary values).

2. Must have had a liver biopsy proven NASH within 6 months or in screening test. Thefollowing two requirements must be met at the same time: ① a non-alcoholic fattyliver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in eachof the following NAS components: Steatosis≥1, Lobular inflammation≥1, Ballooningdegeneration≥1;② fibrosis stage 1 to 3.

3. Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at screening.

4. No alcohol consumption or history of excessive alcohol consumption: less than 210 gof ethanol per week for men and 140 g for women in the past 12 months.

5. Patients who are taking chronic drugs(including but not limited to antihypertensivedrugs, antiatherogenic drugs, oral hypoglycemic drugs, insulin) need to have asteady dose for at least 3 months before liver biopsy.

6. Weight was stable(the change is no more than 5%) during the 6 months prior toScreening.

7. No attempt to change lifestyle (diet and/or exercise) during the 3 months prior toScreening.

8. Ability to understand the requirements of the study and willingness to providewritten informed consent.

9. Have no pregnancy program and take effective contraceptive measures voluntarily.

10. Abide by the experimental protocol and cooperate with the data collection accordingto the researcher's judgment.

Exclusion Criteria:

1. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD)administered for at least 2 weeks within 12 months prior to qualifying liver biopsy (e.g. valproic acid, tamoxifen, methotrexate, amiodarone, oral corticosteroids, >5mg/day of prednisone equivalent [one short (<2 weeks) course of oralcorticosteroids, more than 3 months before the liver biopsy is allowed], oroestrogens [at doses greater than those used for contraception or hormonereplacement]).

2. Documented causes of fatty liver disease other than NASH including, but notrestricted to: HCV-associated fatty liver (genotype 3), hepatolenticulardegeneration, autoimmune hepatitis, total parenteral nutrition,abetalipoproteinemia, lipoatrophy , Coeliac disease, Primary sclerosing cholangitis,Alpha-1-antitrypsin deficiency, Drug-induced liver disease.

3. Model for End-stage Liver Disease (MELD) score >12.

4. Histologically documented liver cirrhosis (fibrosis stage F4), history or currentdiagnosis of hepatocellular carcinoma HCC.

5. History of or planned liver transplant.

6. Viral hepatitis：Positive hepatitis A antibody，Positive hepatitis D antibody，Positivehepatitis E antibody，Positive hepatitis B surface antigen (HBsAg) ，Positivehepatitis C antibody.

7. Abnormal liver function as defined by Screening central laboratory evaluation of anyof the following: ALT or AST >5 × ULN; Alkaline phosphatase (ALP) >2 × ULN; albuminbelow the lower limit of the normal range; total bilirubin level >1.5 × ULN (patients with a documented history of Gilbert's syndrome can be enrolled if thedirect bilirubin is within normal reference range).

8. In patients who are not anticoagulated, INR ≥ 1.3 times ULN or other evidence ofimpaired coagulation.

9. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value <30mL/min/1.73 m2.

10. Patient currently receiving any approved treatment for NASH.

11. HbA1c ≥9% or fasting blood-glucose>13.9 mmol/L at Screening.

12. Diabetes mellitus other than type 2 (e.g. type 1, diabetes caused by drugs orchemicals, and immune-mediated diabetes).

13. Those who are underweight, of normal weight, or severely obese, i.e BMI<23 kg/m2 orBMI≥40 kg/m2.

14. Bariatric surgery or tumor surgery are not allowed within 5 years of the qualifyingliver biopsy.

15. Uncontrolled hypertension (values ≥160/100 mm Hg) or hypotension（values <80/50mmHg）.

16. Acute vascular events including ACS, stroke, peripheral vascular disease worsened,or any vascular/cardiac surgery within the 6 months prior to Screening.

17. Concomitant mental illness and poor condition control, which affects the signing ofinformed consent or presentation of adverse events.

18. Do not have a liver biopsy within the 6 months prior to Screening and refuse to takeliver biopsy at Screening.

19. Allergic constitution, or allergic to the test drug or its ingredients.

20. Women who are pregnant or lactating.

21. Participate in clinical trials of other drugs within 3 months before screening.

22. The researchers did not consider it appropriate to participate in this study.