Clinical trial

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

Active, not recruiting · Phase 3 · 5 countries · Registry ID NCT04822181

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionNon-alcoholic Steatohepatitis

Full registry criteria

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.

Treatments and study arms

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.

Primary outcomes

Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)From randomisation (week 0) to week 72

Count of subject

Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)From randomisation (week 0) to week 72

Count of subject

Part 2: Cirrhosis-free survival (Yes/No)From randomisation (week 0) to week 240

Count of subject

Study locations

558 locations were listed when this page was built. The first 40 are shown.

DIM Clinica Privada🇦🇷 Buenos Aires, Argentina
Centro Médico Viamonte SRL🇦🇷 CABA, Argentina
Glenny Corp. S.A🇦🇷 CABA, Argentina
Hospital Italiano Departamento Hepatologia🇦🇷 CABA, Argentina
Centro de Investigaciones Metabólicas🇦🇷 Capital Federal, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas🇦🇷 Capital Federal, Argentina
Hospital Britanico de Buenos Aires🇦🇷 Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital El Cruce🇦🇷 Florencio Varela, Buenos Aires, Argentina
Hospital del Centenario🇦🇷 Rosario, Santa Fe, Santa Fe Province, Argentina
Royal Adelaide Hospital - Hepatology Department🇦🇺 Adelaide, South Australia, Australia
A.W. Morrow Gastroenterology and Liver Centre🇦🇺 Camperdown, New South Wales, Australia
Lyell McEwin Hospital🇦🇺 Elizabeth Vale, South Australia, Australia
St Vincent's Hospital Melbourne - Gastroenterology Department🇦🇺 Fitzroy, Victoria, Australia
Austin Hospital🇦🇺 Heidelberg, Victoria, Australia
Nepean Hospital🇦🇺 Kingswood, New South Wales, Australia
Liverpool Hospital🇦🇺 Liverpool, New South Wales, Australia
Fiona Stanley Hospital - Hepatology🇦🇺 Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital - Hepatology Department🇦🇺 Nedlands, Western Australia, Australia
Griffith University Clinical Trial Unit🇦🇺 Southport, Queensland, Australia
Westmead Hospital🇦🇺 Westmead, New South Wales, Australia
Westmead Hospital - Storr Liver Centre🇦🇺 Westmead, New South Wales, Australia
Klin.Abt. f. Gastroenterologie u. Hepatologie🇦🇹 Graz, Austria
Fließer-Görzer [Ordination]🇦🇹 Saint Stefan, Austria
LKH Salzburg Universitätsklinikum🇦🇹 Salzburg, Austria
Klinik Landstraße🇦🇹 Vienna, Austria
Klinikum Wels-Grieskirchen🇦🇹 Wels, Austria
CUB Hôpital Erasme_Brussels_0🇧🇪 Brussels, Belgium
Cliniques Universitaires Saint-Luc - Serv. Hépato-gastroentérology🇧🇪 Brussels, Belgium
UZA🇧🇪 Edegem, Belgium
Ziekenhuis Oost-Limburg AV - Gastro🇧🇪 Genk, Belgium
AZ Maria Middelares - Gent - Gastro-Enterology🇧🇪 Ghent, Belgium
UZ Gent - Department Gastro-enterology🇧🇪 Ghent, Belgium
Fundação Pio XII🇧🇷 Barretos, São Paulo, Brazil
Fundação Pio XII - Hospital de Amor de Barretos🇧🇷 Barretos, São Paulo, Brazil
UPECLIN- Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu🇧🇷 Botucatu, São Paulo, Brazil
Hospital das Clínicas da Universidade Federal de Goiás🇧🇷 Goiânia, Goiás, Brazil
Hospital de Clínicas de Porto Alegre_Porto Alegre🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil
Hospital Universitario Clementino Fraga Filho🇧🇷 Rio de Janeiro, Brazil
Fundação Bahiana de Infectologia🇧🇷 Salvador, Estado de Bahia, Brazil
CIP Centro Integrado de Pesquisas do Hospital de Base🇧🇷 São José do Rio Preto, São Paulo, Brazil