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Clinical Trials in the UK / NCT04822181
Active, not recruiting Phase 3

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

NCT04822181 · tracked via the Priya Life Science UK tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2021-04-01
Last updated
2026-09-04

Condition(s) studied

Non-alcoholic Steatohepatitis

Investigational drug(s) / intervention(s)

SemaglutidePlacebo

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

Placebo: Placebo administrated subcutaneously (under the skin) once weekly.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age above or equal to 18 years at the time of signing informed consent. * Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to the screening visit (V1). * 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. * A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy. Exclusion Criteria: * Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD) * 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). * Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation. * Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)). * Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening. * Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A). * Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.

Primary outcome measure(s)

Trial sites (558)

FacilityCityRegionStatus
North AL Health Res, LLC Huntsville Alabama
The Institute for Liver Health Chandler Arizona
Inst-Liver Hlth dba AZ Liver H Peoria Arizona
Inst. Liver H II dba AZ Liver H Tucson Arizona
Del Sol Research Management, LLC Tucson Arizona
ARcare Center for Clinical Research Jonesboro Arkansas
ARcare Center for Clinical Research Little Rock Arkansas
Arkansas Diagnostic Center, PA Little Rock Arkansas
Gastroenterology & Liver Institute Escondido California
Shang Wu M.D. Inc. Hacienda Heights California
Scripps Whittier Diabetes Inst La Jolla California
UCSD NAFLD Research Center La Jolla California
OM Research LLC Lancaster California
Digestive Hlth Res of SoCa Long Beach California
OM Research LLC Oxnard California
Cedars-Sinai Medical Center Pasadena California
Pasedena Liver Center Pasadena California
Inland Empire Clin Trials LLC Rialto California
UC Davis Hlth -Midtwn Ambu Cen Sacramento California
University of California, San Francisco San Francisco California
San Jose Gastroenterology San Jose California
Peak Gastro Assoc-Col Springs Colorado Springs Colorado
Yale Ctr for Clin Invest New Haven Connecticut
Encore Medical Research of Boynton Beach LLC Boynton Beach Florida
Integrity Clinical Research, LLC Doral Florida
Covenant Metabolic Specialists, Ft. Myers Fort Myers Florida
University of Florida-CTRB Gainesville Florida
Miguel Rebollar PA Hialeah Florida
Direct Helpers Research Center Hialeah Florida
Florida Research Institute, LLC Lakewood Rch Florida
Sandhill Research, LLC Maitland Florida
Tandem Clinical Research - Maitland Maitland Florida
Optimus U, Corp Miami Florida
Univ of Miami/Schiff Ctr Miami Florida
Genoma Research Group, Inc Miami Florida
IMIC Inc Miami Florida
San Marcus Res Clin Miami Lakes Miami Lakes Florida
Ocala GI Research Ocala Florida
Sensible Healthcare LLC Ocoee Florida
Covenant Metabolic Specialists LLC Sarasota Florida

+ 518 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

More Novo Nordisk A/S trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04822181 on ClinicalTrials.gov ↗ ← All trials in the UK