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Semaglutide for Non-alcoholic Steatohepatitis (NASH)(ESSENCE Trial)

clinical research professionals, Chesterfield, MO
Semaglutide +1 morePhase 3RecruitingResearch Sponsored by Novo Nordisk A/S

ESSENCE 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.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

ESSENCE Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

ESSENCE Trial 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

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 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
Decreased Appetite
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.

ESSENCE 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
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Find a Location


Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,476 Previous Clinical Trials
2,367,323 Total Patients Enrolled
16 Trials studying Non-alcoholic Fatty Liver Disease
3,110 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,012 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given Semaglutide the green light?

"Semaglutide has received a score of 3, indicating that while it is still in Phase 3 clinical trials, there is data to support both its efficacy and safety."

Answered by AI

Are there still opportunities for people to participate in this research project?

"Yes, this is an active trial recruiting patients. The first posting was on April first 2021 with the most recent update on February twenty-fourth 2022. They are looking for a total of 1200 people across eighty-nine different sites."

Answered by AI

Will this clinical trial be the first to test this new treatment?

"Semaglutide has been the focus of 59 active studies in 55 countries and 711 cities since the drug's initial study in 2018. The first study, sponsored by Novo Nordisk A/S, completed Phase 4 drug approval in 2018 with 1387 patients. A total of 18349 studies have been conducted since then."

Answered by AI

Semaglutide is sometimes used for type 2 diabetes, correct?

"Semaglutide can help patients with chronic weight management, those looking to reduce their calorie intake, and those trying to increase their exercise levels."

Answered by AI

Could you provide some context for this study by sharing what other research has been conducted on Semaglutide?

"Semaglutide was first trialed in 2018 by Novo Nordisk. Since the initial study, there have been 18349 completed clinical trials. Right now, 59 different medical studies are actively recruiting, many of which are based in Terrebonne, Quebec."

Answered by AI

How many research facilities are testing this new medication?

"There are 89 sites around the country where this trial is recruiting patients. While Terrebonne, Houston and McAllen have trial sites, other locations might be closer to you. When enrolling, it is best to consider a site that will minimize travel."

Answered by AI

Why was this clinical trial started in the first place?

"The main goal of this study, which will last 72 weeks, is to Part 2: Time to first liver-related clinical event (composite endpoint). Other objectives include Change in HDL (High density lipoprotein ) cholesterol which is defined as Ratio to baseline, Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No) which is defined as Count of subjects, and Change in ALT (alanine aminotransferase) which is defined as Ratio to baseline."

Answered by AI

How many people have enrolled in this trial thus far?

"That is right, the clinical trial is recruiting 1200 participants from 89 locations. The information was first posted on 4/1/2021 and was most recently edited on 2/24/2022."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

What questions have other patients asked about this trial?

How long does screening take? How long does screenings take? How often are visits and how long per visit?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

FOr my liver health. I wish to fix my liver! I was diagnosed with fatty liver.
PatientReceived 1 prior treatment
Would like to see if it would help. I’m scared and not ready to give up.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
Average response time
  • < 2 Days
~743 spots leftby Apr 2028