Semaglutide for Non-alcoholic Steatohepatitis

(ESSENCE Trial)

Recruiting at 844 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 0

1205 Participants Needed

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.

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.

Treatment Details

Interventions

• Placebo
• Semaglutide

Trial Overview 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.

Participant Groups

Group I: Semaglutide OW (once weekly ) Experimental Treatment 1 Intervention

Semaglutide administrated subcutaneously once weekly

Group II: Placebo Placebo Group 1 Intervention

Placebo administrated subcutaneously once weekly

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

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