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Non-alcoholic SteatohepatitisPhase 2EASYBEinNASHNCT03198572

Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis

A Phase 2 study testing Lifestyle intervention and Berberine in people with Non-alcoholic Steatohepatitis, run by Fudan University at 6 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-alcoholic Steatohepatitis
What is being tested?
Lifestyle intervention and Berberine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
89 participants
Where
6 sitesChina
Study dates
16 Aug 2017to 20 Feb 2025
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

None listed.

Who cannot join

  • Excessive alcohol intake ( > 140 g per week for men and >70 g per week for women within 6 months before enrollment);
  • Liver enzymes (ALT or aspartate aminotransferase(AST) is 5 times higher than the upper limit of normal range;
  • Liver diseases caused by other reasons, such as alcohol abuse, viral hepatitis, drugs, auto-immune hepatitis, hereditary liver disease, liver cirrhosis, liver cancer, etc;
  • Biliary tract diseases, biliary obstructive disease, etc;
  • Other diseases that affect glucose and lipid metabolism, such as hypothyroidism, hyperthyroidism, hypercortisolism, etc;
  • Diabetic patients with poor blood glucose control: HbA1c >9.5%;
Show all 13Show fewer
  • Use of drugs that may affect the outcome measures of this study 3 months before enrollment, including pioglitazone, GLP-1 receptor agonist, DPP-4 inhibitor, insulin, and glycyrrhizic acid preparation, etc;
  • Chronic kidney disease or severe renal impairment, defined as serum creatinine greater than 2.0mg/dL (176.8umol/L);
  • Life expectancy is no more than 5 years;
  • Pregnant or planning to become pregnant within the next 64 weeks for female participant;
  • Any situation that may affect the implementation or results of the study;
  • Continuous use of drugs that may affect steatohepatitis 3 months before enrollment, such as glucocorticoids, methotrexate, etc;
  • Subjects participated in other clinical trials in the past 4 weeks; The researchers did not think they were suitable for the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou

  • Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital

    Shanghai, Shanghai Municipality

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

  • Tianjin Third Central Hospital

    Tianjin

  • Xinjiang Medical University

    Ürümqi

Other trials in China

About this study

Official title: Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis: a Multicentre, Randomised, Placebo-controlled Trial

The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.

Read the detailed description

This is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate the efficacy and safety of berberine on subjects with Non-alcoholic Steatohepatitis.Patients with biopsy-proven non-alcoholic steatohepatitis (NASH) from 18-65 years of age were enrolled. Patients should had no excessive alcohol intake or use of any hepatoprotective or hepatotoxicity medication within 3 months before enrollment.Patients will have an screening period 12 weeks, and a 48-week double-blinded treatment period.

Being tested
Lifestyle intervention, Placebo, Berberine
Keywords
Non-alcoholic steatohepatitis
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionBehavioural

    Lifestyle intervention is consisted of diet control and aerobic exercise. calorie restriction: to subtract 500 kcal from daily calorie intake aerobic exercise: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate.

  • PlaceboDrug

    placebo tablets 0.5 tid, 30 minutes before each meal, for 48weeks

  • BerberineDrug

    Berberine tablets 0.5 tid, 30 minutes before each meal, for 48weeks

Study groups in NCT03198572
Study groupRoleWhat they receive
BerberineExperimentalBerberine was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
Receives: Behavioral: Lifestyle intervention; Drug: Berberine
PlaceboPlacebo comparatorPlacebo was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
Receives: Behavioral: Lifestyle intervention; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS)

    A separate system of scoring the histological features of nonalcoholic fatty liver disease (NAFLD) called the NAFLD Activity Score (NAS) was used. An improvement in histologic findings require an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.

    Measured: 48 weeks

Secondary outcomes (7)

  1. Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning

    NAFLD activity score (NAS) is composed of steatosis (scale of 0 to 3), lobular inflammation (scale of 0 to 3), hepatocellular ballooning (scale of 0 to 2). Alteration in each component of NAS is measured.

    Measured: 48 weeks

  2. Improvement in liver histological fibrosis staging

    Fibrosis staging was measured as following criteria: 0=none, 1=perisinusoidal or periportal fibrosis, 2=perisinusoidal and portal/periportal fibrosis, 3=bridging fibrosis, and 4=cirrhosis.the definition of fibrosis stages improvement requires at least one stage.

    Measured: 48 weeks

  3. Resolution of NASH

    Resolution of NASH was defined as a diagnosis of no steatohepatitis at 48 weeks among those with possible or definite NASH at baseline.

    Measured: 48 weeks

  4. Change in anthropometric measures

    including BMI etc

    Measured: 48 weeks

  5. Change in blood biochemistry

    including serum aminotransferase levels etc

    Measured: 48 weeks

  6. Change in liver fat content

    liver fat content determined by 1H MRS (in part of clinical centers)

    Measured: 48 weeks

  7. Change in serum cytokeratin 18 (CK-18) in U/L

    serum cytokeratin 18 (CK-18) in U/L

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2017
  2. Study start16 Aug 2017
  3. Primary completion14 Nov 2024
  4. Study completion20 Feb 2025

Why it stopped: Enrolment terminated early owing to slow accrual (repeat-biopsy burden and COVID-19 pandemic), following a protocol-specified interim analysis approved by the ethics committee (2017-050(5)).

Resources

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
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03198572
Sponsor's protocol ID
2016ZSLC04
Acronym
EASYBEinNASH
Status last verified
Mar 2025
First submitted
18 Jun 2017
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.

    PubMed 15565570

  • Williams CD, Stengel J, Asike MI, Torres DM, Shaw J, Contreras M, Landt CL, Harrison SA. Prevalence of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis among a largely middle-aged population utilizing ultrasound and liver biopsy: a prospective study. Gastroenterology. 2011 Jan;140(1):124-31. doi: 10.1053/j.gastro.2010.09.038. Epub 2010 Sep 19.

    PubMed 20858492

  • Li Z, Xue J, Chen P, Chen L, Yan S, Liu L. Prevalence of nonalcoholic fatty liver disease in mainland of China: a meta-analysis of published studies. J Gastroenterol Hepatol. 2014 Jan;29(1):42-51. doi: 10.1111/jgh.12428.

    PubMed 24219010

  • Garcia-Monzon C, Martin-Perez E, Iacono OL, Fernandez-Bermejo M, Majano PL, Apolinario A, Larranaga E, Moreno-Otero R. Characterization of pathogenic and prognostic factors of nonalcoholic steatohepatitis associated with obesity. J Hepatol. 2000 Nov;33(5):716-24. doi: 10.1016/s0168-8278(00)80301-3.

    PubMed 11097478

  • Gupte P, Amarapurkar D, Agal S, Baijal R, Kulshrestha P, Pramanik S, Patel N, Madan A, Amarapurkar A, Hafeezunnisa. Non-alcoholic steatohepatitis in type 2 diabetes mellitus. J Gastroenterol Hepatol. 2004 Aug;19(8):854-8. doi: 10.1111/j.1440-1746.2004.03312.x.

    PubMed 15242486

  • Musso G, Gambino R, Cassader M, Pagano G. Meta-analysis: natural history of non-alcoholic fatty liver disease (NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity. Ann Med. 2011 Dec;43(8):617-49. doi: 10.3109/07853890.2010.518623. Epub 2010 Nov 2.

    PubMed 21039302

  • Kotronen A, Yki-Jarvinen H. Fatty liver: a novel component of the metabolic syndrome. Arterioscler Thromb Vasc Biol. 2008 Jan;28(1):27-38. doi: 10.1161/ATVBAHA.107.147538. Epub 2007 Aug 9.

    PubMed 17690317

  • Targher G, Day CP, Bonora E. Risk of cardiovascular disease in patients with nonalcoholic fatty liver disease. N Engl J Med. 2010 Sep 30;363(14):1341-50. doi: 10.1056/NEJMra0912063. No abstract available.

    PubMed 20879883

  • Cali AM, Zern TL, Taksali SE, de Oliveira AM, Dufour S, Otvos JD, Caprio S. Intrahepatic fat accumulation and alterations in lipoprotein composition in obese adolescents: a perfect proatherogenic state. Diabetes Care. 2007 Dec;30(12):3093-8. doi: 10.2337/dc07-1088. Epub 2007 Aug 23.

    PubMed 17717283

  • Shen L. Treatment implication from the potential association between nonalcoholic fatty liver disease and cardiovascular disease. Hepatology. 2011 Jul;54(1):377-8. doi: 10.1002/hep.24213. No abstract available.

    PubMed 21710476

  • Schwimmer JB, Pardee PE, Lavine JE, Blumkin AK, Cook S. Cardiovascular risk factors and the metabolic syndrome in pediatric nonalcoholic fatty liver disease. Circulation. 2008 Jul 15;118(3):277-83. doi: 10.1161/CIRCULATIONAHA.107.739920. Epub 2008 Jun 30.

    PubMed 18591439

  • Hamaguchi M, Kojima T, Takeda N, Nakagawa T, Taniguchi H, Fujii K, Omatsu T, Nakajima T, Sarui H, Shimazaki M, Kato T, Okuda J, Ida K. The metabolic syndrome as a predictor of nonalcoholic fatty liver disease. Ann Intern Med. 2005 Nov 15;143(10):722-8. doi: 10.7326/0003-4819-143-10-200511150-00009.

    PubMed 16287793

  • Lin SC, Ang B, Hernandez C, Bettencourt R, Jain R, Salotti J, Richards L, Kono Y, Bhatt A, Aryafar H, Lin GY, Valasek MA, Sirlin CB, Brouha S, Loomba R. Cardiovascular risk assessment in the treatment of nonalcoholic steatohepatitis: a secondary analysis of the MOZART trial. Ther Adv Gastroenterol. 2016 Mar;9(2):152-61. doi: 10.1177/1756283X15621232.

    PubMed 26929777

  • Marchesini G, Moscatiello S, Di Domizio S, Forlani G. Obesity-associated liver disease. J Clin Endocrinol Metab. 2008 Nov;93(11 Suppl 1):S74-80. doi: 10.1210/jc.2008-1399.

    PubMed 18987273

  • Kistler KD, Brunt EM, Clark JM, Diehl AM, Sallis JF, Schwimmer JB; NASH CRN Research Group. Physical activity recommendations, exercise intensity, and histological severity of nonalcoholic fatty liver disease. Am J Gastroenterol. 2011 Mar;106(3):460-8; quiz 469. doi: 10.1038/ajg.2010.488. Epub 2011 Jan 4.

    PubMed 21206486

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lifestyle intervention and Berberine in people with Non-alcoholic Steatohepatitis, run by Fudan University at 6 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 0 inclusion and 13 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: stopped early, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

The study was stopped early (reason given: Enrolment terminated early owing to slow accrual (repeat-biopsy burden and COVID-19 pandemic), following a protocol-specified interim analysis approved by the ethics committee (2017-050(5)).). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03198572, which also lists 31 linked publications.

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 23 Sep 2026.

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