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Semaglutide for Non-alcoholic Steatohepatitis (ESSENCE Trial)
Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age above or equal to 18 years at the time of signing informed consent.
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.
Must not have
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.
Timeline
Screening 14 days
Treatment 216 weeks
Follow Up 7 days
Awards & highlights
Summary
This trial is studying a medication called semaglutide in patients with NASH. Semaglutide is a well-known medication used to treat type 2 diabetes, and participants will either receive semaglutide or a dummy medication, with no way of knowing which they're getting. The study will last for 5 years, during which participants will have to inject themselves weekly and will have 21 clinic visits and 9 phone calls with clinical staff. Some of the clinic visits may last more than one day.
Who is the study for?
Adults with a specific liver condition called NASH and fibrosis stages 2 or 3 can join this study. They must have evidence of NASH from a recent biopsy, not be on certain unstable medications, and cannot have other chronic liver diseases or excessive alcohol use. Pregnant women or those planning pregnancy are excluded.
What is being tested?
The trial is testing Semaglutide, already used for type 2 diabetes, against a placebo to see if it helps with NASH. Participants will inject themselves weekly and the study spans about five years with regular clinic visits and phone check-ins.
What are the potential side effects?
While the side effects aren't detailed here, Semaglutide in diabetes care may cause digestive issues like nausea or diarrhea, potential low blood sugar events, and sometimes allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My liver fibrosis is at stage 2 or 3 according to a biopsy.
Select...
My liver disease score is 4 or higher, with signs of fat, inflammation, and cell damage.
Select...
My liver fibrosis is at stage 2 or 3 according to a specialist's review.
Select...
My liver disease score is 4 or higher, with signs of fat, inflammation, and cell damage.
Select...
I am willing to undergo a liver biopsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My chronic liver disease is not due to non-alcoholic fatty liver disease.
Select...
I have or had serious liver-related health issues or a liver transplant.
Select...
I haven't taken GLP-1 receptor agonists in the last 90 days or since my last liver biopsy.
Timeline
Screening ~ 14 days3 visits
Treatment ~ 216 weeks21 visits
Follow Up ~ 7 days0 visits
Screening ~ 14 days
Treatment ~ 216 weeks
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Part 2: Time to first liver-related clinical event (composite endpoint)
Secondary outcome measures
Change in ALT (alanine aminotransferase)
Change in AST (aspartate aminotransferase)
Change in ELF (Enhanced Liver Fibrosis) score
+24 moreSide effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide OW (once weekly )Experimental Treatment1 Intervention
Semaglutide administrated subcutaneously once weekly
Group II: PlaceboPlacebo Group1 Intervention
Placebo administrated subcutaneously once weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,525 Previous Clinical Trials
2,418,536 Total Patients Enrolled
17 Trials studying Non-alcoholic Fatty Liver Disease
3,145 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
43,955 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
714 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver disease score is 4 or higher, with signs of fat, inflammation, and cell damage.You drink too much alcohol or have an addiction to alcohol.I am 18 years old or older.I haven't changed my dose of vitamin E, pioglitazone, or NASH medication in the last 90 days.My liver fibrosis is at stage 2 or 3 according to a specialist's review.My diabetes, cholesterol, or weight loss medication doses have been stable for the last 3 months.My liver fibrosis is at stage 2 or 3 according to a biopsy.My liver biopsy confirms I have NASH.I have or had serious liver-related health issues or a liver transplant.I haven't taken GLP-1 receptor agonists in the last 90 days or since my last liver biopsy.I am willing to undergo a liver biopsy.My liver disease score is 4 or higher, with signs of fat, inflammation, and cell damage.I am 18 years old or older.My liver biopsy confirms I have NASH.My chronic liver disease is not due to non-alcoholic fatty liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Semaglutide OW (once weekly )
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 14 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 216 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 7 Months after you stop receiving the treatment.
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04822181 — Phase 3
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