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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04822181




Registration number
NCT04822181
Ethics application status
Date submitted
26/03/2021
Date registered
30/03/2021

Titles & IDs
Public title
Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
Scientific title
The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis
Secondary ID [1] 0 0
U1111-1244-3678
Secondary ID [2] 0 0
NN9931-4553
Universal Trial Number (UTN)
Trial acronym
ESSENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo

Experimental: Semaglutide OW (once weekly ) - Semaglutide administrated subcutaneously once weekly

Placebo comparator: Placebo - Placebo administrated subcutaneously once weekly


Treatment: Drugs: Semaglutide
Semaglutide administrated subcutaneously (under the skin) once weekly there will be a period of dose escalation before reaching the target dose.

Treatment: Drugs: Placebo
Placebo administrated subcutaneously (under the skin) once weekly.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Timepoint [1] 0 0
From randomisation (week 0) to week 72
Primary outcome [2] 0 0
Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
Timepoint [2] 0 0
From randomisation (week 0) to week 72
Primary outcome [3] 0 0
Part 2: Cirrhosis-free survival (Yes/No)
Timepoint [3] 0 0
From randomisation (week 0) to week 240
Secondary outcome [1] 0 0
Change in body weight
Timepoint [1] 0 0
From randomisation (week 0) to week 72
Secondary outcome [2] 0 0
Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
Timepoint [2] 0 0
From randomisation (week 0) to week 72
Secondary outcome [3] 0 0
Change in SF-36 (Short Form 36) Bodily Pain
Timepoint [3] 0 0
From randomisation (week 0) to week 72
Secondary outcome [4] 0 0
Change in body weight
Timepoint [4] 0 0
From randomisation (week 0) to week 240
Secondary outcome [5] 0 0
Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)
Timepoint [5] 0 0
From randomisation (week 0) to week 72
Secondary outcome [6] 0 0
Change in histology-assessed liver collagen proportionate area
Timepoint [6] 0 0
From randomisation (week 0) to week 72
Secondary outcome [7] 0 0
Worsening in steatohepatitis (Yes/No)
Timepoint [7] 0 0
From randomisation (week 0) to week 72
Secondary outcome [8] 0 0
Improvement in histology-assessed ballooning (Yes/No)
Timepoint [8] 0 0
From randomisation (week 0) to week 72
Secondary outcome [9] 0 0
Improvement in histology-assessed inflammation (Yes/No)
Timepoint [9] 0 0
From randomisation (week 0) to week 72
Secondary outcome [10] 0 0
Improvement in histology-assessed steatosis (Yes/No)
Timepoint [10] 0 0
From randomisation (week 0) to week 72
Secondary outcome [11] 0 0
NASH resolution (ballooning of 0, inflammation of 0-1) and above or equal to 2point NAS reduction with no worsening of fibrosis
Timepoint [11] 0 0
From randomisation (week 0) to week 72
Secondary outcome [12] 0 0
Progression of liver fibrosis in patients with F2 at baseline (Yes/No)
Timepoint [12] 0 0
From randomisation (week 0) to week 72
Secondary outcome [13] 0 0
Progression of liver fibrosis
Timepoint [13] 0 0
From randomisation (week 0) to week 72
Secondary outcome [14] 0 0
Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Timepoint [14] 0 0
From randomisation (week 0) to week 240
Secondary outcome [15] 0 0
Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
Timepoint [15] 0 0
From randomisation (week 0) to week 240
Secondary outcome [16] 0 0
Changes in liver stiffness values assessed by transient elastography (FibroScan®)
Timepoint [16] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [17] 0 0
Change in ELF (Enhanced Liver Fibrosis) score
Timepoint [17] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [18] 0 0
Change in ALT (alanine aminotransferase)
Timepoint [18] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [19] 0 0
Change in AST (aspartate aminotransferase)
Timepoint [19] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [20] 0 0
Change in CAP (Controlled Attenuation Parameter) values assessed by transient elastography (FibroScan)
Timepoint [20] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [21] 0 0
Change in FAST (FibroScan-AST) score
Timepoint [21] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [22] 0 0
Change in Pro-C3 (pro-peptide of type III collagen)
Timepoint [22] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [23] 0 0
Change in inflammation assessed by hsCRP (High Sensitive C-Reactive Protein)
Timepoint [23] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [24] 0 0
Change in HbA1c (glycated haemoglobin)
Timepoint [24] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [25] 0 0
Change in triglyceride
Timepoint [25] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [26] 0 0
Change in free fatty acids
Timepoint [26] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [27] 0 0
Change in LDL (low-density lipoprotein) cholesterol
Timepoint [27] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [28] 0 0
Change in HDL (High density lipoprotein ) cholesterol
Timepoint [28] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [29] 0 0
Time to first MACE(Major Adverse Cardiovascular event ) (composite endpoint)
Timepoint [29] 0 0
From randomisation (week 0) to week 240
Secondary outcome [30] 0 0
Major cardio-hepatic event-free survival (Yes/No)
Timepoint [30] 0 0
From randomisation (week 0) to week 240
Secondary outcome [31] 0 0
Changes in SF-36 (Short Form 36 v2.0 acute ) Physical Component Summary
Timepoint [31] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [32] 0 0
Changes in SF-36 Mental Component Summary
Timepoint [32] 0 0
From randomisation (week 0) to week 72 and week 240
Secondary outcome [33] 0 0
Change in SF-36 Bodily Pain
Timepoint [33] 0 0
From randomisation (week 0) to week 240
Secondary outcome [34] 0 0
Changes in NASH-CHECK Abdominal Pain
Timepoint [34] 0 0
From randomisation (week 0) to week 72 and week 240

Eligibility
Key inclusion criteria
* Age above or equal to 18 years at the time of signing informed consent.
* 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 the screening visit (V1).
* Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy.
* A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)
* Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
* 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 greater than 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 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 from time of biopsy until screening.
* Treatment with GLP-1 RAs 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 (V2A).
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/04/2029
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
A.W. Morrow Gastroenterology and Liver Centre - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Griffith University Clinical Trial Unit - Southport
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Hepatology- 5E291 - Adelaide
Recruitment hospital [6] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [7] 0 0
St Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [8] 0 0
Austin Health - Heidelberg
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Hepatology - Murdoch
Recruitment hospital [10] 0 0
Sir Charles Gairdner Hospital_Nedlands - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4222 - Southport
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
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Arizona
Country [3] 0 0
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Roma
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Rome
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Torino
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Bunkyo-ku, Tokyo
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Japan
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Fukui-shi, Fukui
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Fukushima
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Gifu
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Hamamatsu-shi, Shizuoka
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Japan
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Hatsukaichi-shi, Hiroshima
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Japan
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Hiroshima-shi, Hiroshima
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Japan
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Izunokuni-shi, Shizuoka
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Japan
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Kagoshima-shi, Kagoshima
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Japan
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Kamigyo-ku, Kyoto
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Japan
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Kanazawa-shi, Ishikawa
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Kashihara-shi, Nara
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Japan
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Kawasaki-shi, Kanagawa
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Japan
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Kumamoto-shi, Kumamoto
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Japan
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Minato-ku, Tokyo
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Japan
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Musashino-shi, Tokyo
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Japan
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Nagakute-shi, Aichi
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Japan
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Nakagamigun, Okinawa
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Japan
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Nara-shi, Nara
Country [140] 0 0
Japan
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Nishinomiya-shi, Hyogo
Country [141] 0 0
Japan
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Oita-shi, Oita
Country [142] 0 0
Japan
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Okayama-shi, Okayama
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Japan
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Osaka-shi, Osaka
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Japan
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Osaka
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Japan
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Otsu-shi, Shiga
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Japan
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Saga-shi, Saga
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Japan
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Sapporo-shi, Hokkaido
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Japan
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Sendai-shi, Miyagi
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Japan
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Shinjuku-ku, Tokyo
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Japan
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Suita-shi, Osaka
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Takamatsu-shi, Kagawa
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Japan
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Takasaki-shi, Gunma
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Japan
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Tokyo
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Japan
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Toon-shi, Ehime
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Wakayama-shi, Wakayama
Country [156] 0 0
Japan
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Yokohama-shi, Kanagawa
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Korea, Republic of
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Kelantan
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Malaysia
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Dundee
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Exeter
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Hull
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Leeds
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
clinicaltrials@novonordisk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Newsome PN, Sanyal AJ, Engebretsen KA, Kliers I, O... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT04822181