Semaglutide for Non-alcoholic Steatohepatitis
(ESSENCE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries.Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance.Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week.The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day.Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.
Will I have to stop taking my current medications?
The trial requires that certain medications be at a stable dose for at least 90 days before the screening visit. If you are taking vitamin E, pioglitazone, GLP-1 RAs, glucose-lowering agents, lipid-lowering medications, or weight loss medications, they must be stable according to the investigator's opinion. You may need to adjust your medications to meet these criteria.
Is semaglutide safe for humans?
Semaglutide has been studied for various conditions, including non-alcoholic steatohepatitis (NASH), and is generally considered safe. It is known to cause significant weight loss and improve liver conditions without severe side effects, making it a safer option compared to some other treatments.12345
How is the drug semaglutide unique in treating non-alcoholic steatohepatitis (NASH)?
Semaglutide is unique in treating NASH because it not only improves liver inflammation and fat accumulation but also leads to significant weight loss, which is beneficial for liver health. Unlike other treatments, semaglutide has shown exclusive potential in resolving NASH, although it may need to be combined with other agents for reversing advanced fibrosis.12456
What data supports the effectiveness of the drug semaglutide for treating non-alcoholic steatohepatitis (NASH)?
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive semaglutide or placebo administered subcutaneously once weekly
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Semaglutide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen