NASHPhase 2NCT05632861
HuHuangLianzonggan Capsule in Subjects With Nonalcoholic Steatohepatitis: a Phase 2 tRial(HHL-HEPAR)
A Phase 2 study testing HuHuangLianzonggan capsule in people with NASH, run by Tasly Pharmaceutical Group Co., Ltd at 20 sites in China.
Trial summary
This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH
- What is being tested?
- HuHuangLianzonggan capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 20 sitesChina
- Study dates
- 21 Feb 2023to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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）.
- Acute vascular events including ACS, stroke, peripheral vascular disease worsened, or any vascular/cardiac surgery within the 6 months prior to Screening.
- Concomitant mental illness and poor condition control, which affects the signing of informed consent or presentation of adverse events.
- Do not have a liver biopsy within the 6 months prior to Screening and refuse to take liver biopsy at Screening.
- Allergic constitution, or allergic to the test drug or its ingredients.
- Women who are pregnant or lactating.
- Participate in clinical trials of other drugs within 3 months before screening.
- The researchers did not consider it appropriate to participate in this study.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites, 20 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Xiaoguang Li, 010-82266699, caitlin901@163.com
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Liangping Li, 028-87393999, 18981838872@163.com
- Not yet recruiting
The first affiliated hospital of Fujian medical university
Fuzhou, Fujian
Yueyong Zhu, 0591-87983333, ezhu066@sina.com
- Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Side Liu, 020-61641888, liuside@163.com
- Recruiting
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang
Junping Shi, 0571-88015050, 13957121199@vip.126.com
- Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui
Yuanyuan Xu, 0551-62283160, 13855184991@163.com
- Not yet recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
Guizhou Zou, 0551-3869420, zouguizhou@126.com
- Recruiting
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu
Wenhai Zhao, 0518-85452253, Zhaowenhai56@163.com
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Yingjian Zhang, 0379-64830604, 13783131268@163.com
- Not yet recruiting
The Affiliated Hospital of Nanjing University medical school，Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Jie Li, 025-83106666, lijier@sina.com
- Recruiting
The Second Hospital of Nanjing
Nanjing, Jiangsu
Yanhong Feng, 025-58006129, aaa_mike@sina.com
- Recruiting
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang
Hongshan Li, 0574-83870999, lihongshan_1982@126.com
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Yufei Song, 0574-87018701, 517582445@qq.com
- Recruiting
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong
Guojun Li, 0755-61222333, 13615880689@163.com
Xin Deng, 0755-61222333
- Recruiting
Taizhou Municipal Hospital
Taizhou, Zhejiang
Qian Jin, 0576-88858000, 13957685075@163.com
- Recruiting
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality
Liang Xu, 022-27468102, xuyangliang2004@sina.com
- Recruiting
Rui'an People's Hospital
Wenzhou, Zhejiang
Liang Hong, 0577-58815881, rahoshongliang@163.com
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
Ling Yang, 027-85726114, 13971178791@163.com
Rong Lin, 027-85726114
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Xuebing Yan, 0516-85609999, Yxbxuzhou@126.com
- Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Huiping Sheng, 0951-6744457, shenghuipingnx@163.com
About this study
Official title: 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.
- Conditions
- NASH
- Being tested
- HuHuangLianzonggan capsule, HuHuangLianzonggan capsule placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuHuangLianzonggan capsuleDrug
Also called Experimental group
HuHuangLianzonggan capsule, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks
HuHuangLianzonggan capsule placeboDrug
Also called Placebo group
HuHuangLianzonggan capsule placebo, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | HuHuangLianzonggan capsule, 4 pills, take orally after meals, 2 times a day Receives: Drug: HuHuangLianzonggan capsule |
| Placebo group | Placebo comparator | HuHuangLianzonggan capsule placebo, 4 pills, take orally after meals, 2 times a day Receives: Drug: HuHuangLianzonggan capsule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hepatic fat fraction assessed by MRI-PDFF at week 12.
Measured: Week 12
Proportion of subjects with ≥ 30% relative fat reduction on MRI-PDFF at week 12.
Measured: Week 12
Secondary outcomes (19)
Change from baseline in weight at week 4, 12.
Measured: Week 4, 12
Change from baseline in Body Mass Index (BMI) at week 4, 12.
Measured: Week 4, 12
Change from baseline in waist hip rate at week 4, 12.
Measured: Week 4, 12
Change from baseline in fasting blood glucose at week 4, 12.
Measured: Week 4, 12
Change from baseline in 2 hours postprandial hyperglycemia at week 4, 12.
Measured: Week 4, 12
Change from baseline in homeostasis model assessment-insulin resistance (HOMA-IR) at week 4, 12.
Measured: Week 4, 12
Change from baseline in Total Cholestrol (TC) at week 4, 12.
Measured: Week 4, 12
Change from baseline in triglyceride (TG) at week 4, 12.
Measured: Week 4, 12
Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) at week 4, 12.
Measured: Week 4, 12
Change from baseline in High Density Lipoprotein Cholesterol (HDL-C) at week 4, 12.
Measured: Week 4, 12
Change from baseline in Glycosylated hemoglobin A1c (HbA1c) at week 12.
Measured: Week 12
Change from baseline in Alanine aminotransferase (ALT) at week 4, 12.
Measured: Week 4, 12
Change from baseline in Aspartate aminotransferase (AST) at week 4, 12.
Measured: Week 4, 12
Change from baseline in total bilirubin (TBil) at week 4, 12.
Measured: Week 4, 12
Change from baseline in Cytokeratin18 (CK-18) at week 4, 12.
Measured: Week 4, 12
Change from baseline in N-terminal type Ⅲ collagen propeptide (Pro-C3) at week 4, 12.
Measured: Week 4, 12
Change from baseline in Fibrosis 4 score at week 4, 12.
Measured: Week 4, 12
Change from baseline in Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD) at week 4, 12.
Measured: Week 4, 12
Change from baseline in ferritin at week 4, 12.
Measured: Week 4, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start21 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632861
- Sponsor's protocol ID
- TSL-TCM-HHLZGJN-NASH-Ⅱ
- Status last verified
- Aug 2024
- First submitted
- 13 Nov 2022
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HuHuangLianzonggan Capsule in Subjects With Nonalcoholic steatoHEPAtitis: a Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 tRial(HHL-HEPAR)
- ClinicalTrials.gov ID
- NCT05632861
- Acronym / sponsor ID
- TSL-TCM-HHLZGJN-NASH-Ⅱ
- Conditions
- NASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: HuHuangLianzonggan capsuleHuHuangLianzonggan capsule, 4 pills, take orally after meals, 2 times a day |
| Placebo group | Placebo comparator | Drug: HuHuangLianzonggan capsule placeboHuHuangLianzonggan capsule placebo, 4 pills, take orally after meals, 2 times a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuHuangLianzonggan capsuleAlso: Experimental groupHuHuangLianzonggan capsule, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks | Drug | Experimental group |
| HuHuangLianzonggan capsule placeboAlso: Placebo groupHuHuangLianzonggan capsule placebo, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks | Drug | Placebo group |
Primary outcome
Change from baseline in hepatic fat fraction assessed by MRI-PDFF at week 12.
Time frame: Week 12
Proportion of subjects with ≥ 30% relative fat reduction on MRI-PDFF at week 12.
Time frame: Week 12
19 secondary outcomes
Change from baseline in weight at week 4, 12.
Time frame: Week 4, 12
Change from baseline in Body Mass Index (BMI) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in waist hip rate at week 4, 12.
Time frame: Week 4, 12
Change from baseline in fasting blood glucose at week 4, 12.
Time frame: Week 4, 12
Change from baseline in 2 hours postprandial hyperglycemia at week 4, 12.
Time frame: Week 4, 12
Change from baseline in homeostasis model assessment-insulin resistance (HOMA-IR) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in Total Cholestrol (TC) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in triglyceride (TG) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in High Density Lipoprotein Cholesterol (HDL-C) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in Glycosylated hemoglobin A1c (HbA1c) at week 12.
Time frame: Week 12
Change from baseline in Alanine aminotransferase (ALT) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in Aspartate aminotransferase (AST) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in total bilirubin (TBil) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in Cytokeratin18 (CK-18) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in N-terminal type Ⅲ collagen propeptide (Pro-C3) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in Fibrosis 4 score at week 4, 12.
Time frame: Week 4, 12
Change from baseline in Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD) at week 4, 12.
Time frame: Week 4, 12
Change from baseline in ferritin at week 4, 12.
Time frame: Week 4, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HuHuangLianzonggan capsule in people with NASH, run by Tasly Pharmaceutical Group Co., Ltd at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hepatic fat fraction assessed by MRI-PDFF at week 12. (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.