Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

NCT04822181 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing whether the medication semaglutide can help people with non-alcoholic steatohepatitis (NASH), a type of liver disease.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 1,205 people

Who can join Ages 18+ · all sexes

Timeline Started 2021-04 · est. completion 2029-04

Where 556 sites · Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT04822181 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide Drug

Semaglutide administrated subcutaneously (under the skin) once weekly there will be a period of dose escalation before reaching the target dose.
Placebo Drug

Placebo administrated subcutaneously (under the skin) once weekly.

Main thing measured	Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Sponsor	Novo Nordisk A/S
Conditions studied	Non-alcoholic Steatohepatitis
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04822181 ↗