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

August 28, 2024 updated by: Tasly Pharmaceutical Group Co., Ltd

Efficacy and Safety of HuHuangLianzonggan Capsule in Subjects With Nonalcoholic steatoHEPAtitis: a Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 tRial(HHL-HEPAR)

This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
      • Hefei, Anhui, China
        • Not yet recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
      • Shenzhen, Guangdong, China
        • Recruiting
        • The Third People's Hospital of Shenzhen
        • Contact:
        • Contact:
          • Xin Deng
          • Phone Number: 0755-61222333
    • Henan
      • Luoyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science And Technology
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
        • Contact:
          • Rong Lin
          • Phone Number: 027-85726114
    • Jiangsu
      • Lianyungang, Jiangsu, China
        • Recruiting
        • The First People's Hospital of Lianyungang
        • Contact:
      • Nanjing, Jiangsu, China
        • Recruiting
        • The Second Hospital of Nanjing
        • Contact:
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • The Affiliated Hospital of Nanjing University medical school，Nanjing Drum Tower Hospital
        • Contact:
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China
        • Not yet recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Second People's Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The affiliated hospital of Hangzhou Normal University
        • Contact:
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo Huamei Hospital, University of Chinese Academy of Sciences
        • Contact:
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Municipal Hospital
        • Contact:
      • Wenzhou, Zhejiang, China
        • Recruiting
        • Rui'an People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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. The following two requirements must be met at the same time: ① a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: Steatosis≥1, Lobular inflammation≥1, Ballooning degeneration≥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 g of 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 antihypertensive drugs, antiatherogenic drugs, oral hypoglycemic drugs, insulin) need to have a steady 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 to Screening.
  7. No attempt to change lifestyle (diet and/or exercise) during the 3 months prior to Screening.
  8. Ability to understand the requirements of the study and willingness to provide written 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 according to 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, >5 mg/day of prednisone equivalent [one short (<2 weeks) course of oral corticosteroids, more than 3 months before the liver biopsy is allowed], or oestrogens [at doses greater than those used for contraception or hormone replacement]).
  2. Documented causes of fatty liver disease other than NASH including, but not restricted to: HCV-associated fatty liver (genotype 3), hepatolenticular degeneration, 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 current diagnosis of hepatocellular carcinoma HCC.
  5. History of or planned liver transplant.
  6. Viral hepatitis：Positive hepatitis A antibody，Positive hepatitis D antibody，Positive hepatitis E antibody，Positive hepatitis B surface antigen (HBsAg) ，Positive hepatitis C antibody.
  7. Abnormal liver function as defined by Screening central laboratory evaluation of any of the following: ALT or AST >5 × ULN; Alkaline phosphatase (ALP) >2 × ULN; albumin below 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 the direct bilirubin is within normal reference range).
  8. In patients who are not anticoagulated, INR ≥ 1.3 times ULN or other evidence of impaired coagulation.
  9. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value <30 mL/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 or chemicals, and immune-mediated diabetes).
  13. Those who are underweight, of normal weight, or severely obese, i.e BMI<23 kg/m2 or BMI≥40 kg/m2.
  14. Bariatric surgery or tumor surgery are not allowed within 5 years of the qualifying liver biopsy.
  15. Uncontrolled hypertension (values ≥160/100 mm Hg) or hypotension（values <80/50 mmHg）.
  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 of informed consent or presentation of adverse events.
  18. Do not have a liver biopsy within the 6 months prior to Screening and refuse to take liver 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
HuHuangLianzonggan capsule, 4 pills, take orally after meals, 2 times a day
Drug: HuHuangLianzonggan capsule
HuHuangLianzonggan capsule, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks
Other Names:
  • Experimental group
Placebo Comparator: Placebo group
HuHuangLianzonggan capsule placebo, 4 pills, take orally after meals, 2 times a day
Drug: HuHuangLianzonggan capsule placebo
HuHuangLianzonggan capsule placebo, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks
Other Names:
  • Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in hepatic fat fraction assessed by MRI-PDFF at week 12.
Time Frame: Week 12
Week 12
Proportion of subjects with ≥ 30% relative fat reduction on MRI-PDFF at week 12.
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in weight at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in Body Mass Index (BMI) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in waist hip rate at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in fasting blood glucose at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in 2 hours postprandial hyperglycemia at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in homeostasis model assessment-insulin resistance (HOMA-IR) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in Total Cholestrol (TC) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in triglyceride (TG) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in High Density Lipoprotein Cholesterol (HDL-C) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in Glycosylated hemoglobin A1c (HbA1c) at week 12.
Time Frame: Week 12
Week 12
Change from baseline in Alanine aminotransferase (ALT) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in Aspartate aminotransferase (AST) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in total bilirubin (TBil) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in Cytokeratin18 (CK-18) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in N-terminal type Ⅲ collagen propeptide (Pro-C3) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in Fibrosis 4 score at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD) at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12
Change from baseline in ferritin at week 4, 12.
Time Frame: Week 4, 12
Week 4, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

November 20, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSL-TCM-HHLZGJN-NASH-Ⅱ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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