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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.
- Non-alcoholic Fatty Liver Disease
ESSENCE Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowESSENCE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT04189848Awards & Highlights
ESSENCE Trial Design
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Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
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- You have a 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.You have histological evidence of non-alcoholic steatohepatitis based on a central pathologist evaluation of the baseline liver biopsy.You cannot have taken high doses of vitamin E or pioglitazone or any medication for NASH that has not been at a steady dose for at least 90 days before the screening. Also, if you had a liver biopsy taken more than 90 days ago, you must have been on a stable dose of medication since then.You have a history of liver issues such as ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation.You drink too much alcohol or have an addiction to alcohol.
- Group 1: Semaglutide OW (once weekly )
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Novo Nordisk Investigational Site: < 24 hours
Average response time
- < 2 Days
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