Clinical Trials List
2021-04-01 - 2029-09-13
Phase III
Not yet recruiting3
Recruiting7
ICD-10K74.4
Secondary biliary cirrhosis
ICD-10K75.81
Nonalcoholic steatohepatitis (NASH)
ICD-10K76.0
Fatty (change of) liver, not elsewhere classified
ICD-10K76.89
Other specified diseases of liver
ICD-10R16.2
Hepatomegaly with splenomegaly, not elsewhere classified
ICD-9571.8
Other chronic nonalcoholic liver disease
The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis
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Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
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Sponsor
Novo Nordisk A/S
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Jia-Horng Kao Digestive System Department
- 曾岱宗 Digestive System Department
- PEI-JER CHEN Digestive System Department
- 洪俊銘 Digestive System Department
- 蘇東弘 Digestive System Department
- 楊宏志 Digestive System Department
- Shih-Jer Hsu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 邱彥程 Digestive System Department
- Chiu Hung Chiu Digestive System Department
- 簡世杰 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王苑貞 Digestive System Department
- 藍耿欣 無
- 黃惠君 Digestive System Department
- Chin-Sung Kuo Division of Endocrinology
- 李癸汌 Digestive System Department
- I-Cheng Lee Digestive System Department
- 吳啟榮 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李忠憲 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jee-Fu Huang Digestive System Department
- 梁博程 Digestive System Department
- Chia-Yen Dai Digestive System Department
- Chung-Feng Huang Digestive System Department
- Ming-Lun Yeh Digestive System Department
- 謝明彥 Digestive System Department
- Wan-Long Chuang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wei-Yu Kao 無
- 黃奕文 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Resolution of
steatohepatitis and no
worsening of liver
fibrosis (Yes/No)
Improvement in liver
fibrosis and no worsening
of steatohepatitis
(Yes/No)：
From randomisation (week 0) to
week 72
Part 2:
Time to first liver-related clinical
event (composite endpoint)：
From randomisation (week 0) to
week 240
Inclution Criteria
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial.
2. Age above or equal to 18 years at the time of signing informed consent.
3. Histological evidence of NASH based on a central pathologist evaluation of the baseline liver
biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to
screening visit (V1).
4. Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN classification
based on a central pathologist evaluation of the baseline liver biopsy.
5. A histological NAS ≥ 4 with a score of 1 or more in both steatosis, lobular inflammation and
hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
Exclusion Criteria
Positive HBsAg (hepatitis B surface antigen), positive anti-HIV (human immunodeficiency virus), positive HCV-RNA (Hepatitis C virus RNA) at screening or any known presence of HCV RNA (ribonucleic acid) or HBsAg within 2 years of screening (V2A).
Documented causes of chronic liver disease other than Non-Alcoholic Fatty Liver Disease NAFLD.
Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire).
Treatment with vitamin E (at doses above or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
Treatment with GLP-1 RAs (glucagon-like peptide-1 receptor agonist) in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening.
Treatment with glucose lowering agent(s) (other than GLP-1 RAs), lipid lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
The Estimated Number of Participants
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Taiwan
35 participants
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Global
1200 participants
