Semaglutide for Non-alcoholic Steatohepatitis
(ESSENCE Trial)

Recruiting in Palo Alto (17 mi)

+843 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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

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 fibrosis is at stage 2 or 3 according to a specialist's review.

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Exclusion Criteria

You drink too much alcohol or have an addiction to alcohol.

Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).

I haven't changed my dose of vitamin E, pioglitazone, or NASH medication in the last 90 days.

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Treatment Details

Interventions

Placebo (Other)
Semaglutide (Glucagon-like peptide-1 receptor agonist)

Trial OverviewThe 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.

Participant Groups

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