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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
Pivotal Trial

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 below
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I am 18 years old or older.
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My liver fibrosis is at stage 2 or 3 according to a biopsy.
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My liver disease score is 4 or higher, with signs of fat, inflammation, and cell damage.
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My liver fibrosis is at stage 2 or 3 according to a specialist's review.
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My liver disease score is 4 or higher, with signs of fat, inflammation, and cell damage.
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I am willing to undergo a liver biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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.
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I haven't taken GLP-1 receptor agonists in the last 90 days or since my last liver biopsy.

Timeline

Screening ~ 14 days
Treatment ~ 216 weeks
Follow Up ~7 days
This trial's timeline: 14 days for screening, 216 weeks for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Change in ALT (alanine aminotransferase)
Change in AST (aspartate aminotransferase)
Change in ELF (Enhanced Liver Fibrosis) score
+24 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,552 Previous Clinical Trials
2,443,835 Total Patients Enrolled
19 Trials studying Non-alcoholic Fatty Liver Disease
13,195 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
44,165 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
714 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04822181 — Phase 3
Non-alcoholic Fatty Liver Disease Research Study Groups: Semaglutide OW (once weekly ), Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04822181 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04822181 — Phase 3
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04822181 — Phase 3
~571 spots leftby Apr 2028
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