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

NCT05632861 | Recruiting Phase 2

• 1 other identifier: TSL-TCM-HHLZGJN-NASH-Ⅱ
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

NASH

Outcome Measures

Primary Outcomes (2)

• Change from baseline in hepatic fat fraction assessed by MRI-PDFF at week 12.

  Week 12

• Proportion of subjects with ≥ 30% relative fat reduction on MRI-PDFF at week 12.

  Week 12

Secondary Outcomes (19)

• Change from baseline in weight at week 4, 12.

  Week 4, 12

• Change from baseline in Body Mass Index (BMI) at week 4, 12.

  Week 4, 12

• Change from baseline in waist hip rate at week 4, 12.

  Week 4, 12

• Change from baseline in fasting blood glucose at week 4, 12.

  Week 4, 12

• Change from baseline in 2 hours postprandial hyperglycemia at week 4, 12.

  Week 4, 12

Study Arms (2)

Experimental group

EXPERIMENTAL

HuHuangLianzonggan capsule, 4 pills, take orally after meals, 2 times a day

Drug: HuHuangLianzonggan capsule

Placebo group

PLACEBO COMPARATOR

HuHuangLianzonggan capsule placebo, 4 pills, take orally after meals, 2 times a day

Drug: HuHuangLianzonggan capsule placebo

Interventions

HuHuangLianzonggan capsule DRUG

HuHuangLianzonggan capsule, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks

Also known as: Experimental group

Experimental group

HuHuangLianzonggan capsule placebo DRUG

HuHuangLianzonggan capsule placebo, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks

Also known as: Placebo group

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18-75 years of age inclusive(including boundary values).
• 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.
• Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
• 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.
• 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.
• Weight was stable(the change is no more than 5%) during the 6 months prior to Screening.
• No attempt to change lifestyle (diet and/or exercise) during the 3 months prior to Screening.
• Ability to understand the requirements of the study and willingness to provide written informed consent.
• Have no pregnancy program and take effective contraceptive measures voluntarily.
• Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment.

You may not qualify if:

• 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 \[at doses greater than those used for contraception or hormone replacement\]).
• 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.
• Model for End-stage Liver Disease (MELD) score \>12.
• Histologically documented liver cirrhosis (fibrosis stage F4), history or current diagnosis of hepatocellular carcinoma HCC.
• History of or planned liver transplant.
• Viral hepatitis：Positive hepatitis A antibody，Positive hepatitis D antibody，Positive hepatitis E antibody，Positive hepatitis B surface antigen (HBsAg) ，Positive hepatitis C antibody.
• 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).
• In patients who are not anticoagulated, INR ≥ 1.3 times ULN or other evidence of impaired coagulation.
• Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value \<30 mL/min/1.73 m2.
• Patient currently receiving any approved treatment for NASH.
• HbA1c ≥9% or fasting blood-glucose\>13.9 mmol/L at Screening.
• Diabetes mellitus other than type 2 (e.g. type 1, diabetes caused by drugs or chemicals, and immune-mediated diabetes).
• Those who are underweight, of normal weight, or severely obese, i.e BMI\<23 kg/m2 or BMI≥40 kg/m2.
• Bariatric surgery or tumor surgery are not allowed within 5 years of the qualifying liver biopsy.
• Uncontrolled hypertension (values ≥160/100 mm Hg) or hypotension（values \<80/50 mmHg）.

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (20)

Anhui Provincial Hospital

Hefei, Anhui, China

NOT YET RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

NOT YET RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

The first affiliated hospital of Fujian medical university

Fuzhou, Fujian, China

NOT YET RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

The Third People's Hospital of Shenzhen

Shenzhen, Guangdong, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

RECRUITING

The Affiliated Hospital of Nanjing University medical school，Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

NOT YET RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

RECRUITING

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

RECRUITING

Taizhou Municipal Hospital

Taizhou, Zhejiang, China

RECRUITING

Rui'an People's Hospital

Wenzhou, Zhejiang, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: December 1, 2022
• Study Start: February 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

CN (20)