NCT04639414 - Combined Active Treatment in Type 2 Diabetes with NASH | Biotech Hunter

Enrollment

192

Participants

Timeline

Start Date

March 26, 2021

Primary Completion Date

January 31, 2025

Study Completion Date

December 31, 2025

Conditions

Type 2 DiabetesNon-alcoholic Steatohepatitis (NASH)Non-alcoholic Fatty Liver Disease (NAFLD)

Interventions

DRUG

Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector

Measurement of the effect of the combined treatment with semaglutide 1mg/week and empagliflozin 10 mg/d compared to matching placebo after 48-week treatment.

DRUG

Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutide

Measurement of the effect of empagliflozin monotherapy 10mg/d compared to matching placebo after 48-week treatment.

DRUG

Placebo matching empagliflozin and placebo pen injector matching semaglutide

Measurement of the effect of the combined treatment with semaglutide 1mg/week and empagliflozin 10 mg/d OR empagliflozin monotherapy 10mg/d compared to matching placebo after 48-week treatment.

Trial Locations (26)

1030

Wiener Gesundheitsverbund, Klinik Landstraße, Vienna

8010

Medizinische Universität Graz, Graz

10787

Franziskus-Krankenhaus Berlin, Berlin

10961

Leber- und Studienzentrum Checkpoint, Berlin

12200

University Clinics Berlin Charité, Berlin

13353

University Clinics Berlin Charité, Berlin

14770

Städtisches Klinikum Brandenburg GmbH, Brandenburg

32545

Herz- und Diabeteszentrum NRW, Bad Oeynhausen

38126

Städtisches Klinikum Braunschweig gGmbH, Braunschweig

40225

German Diabetes Center, Düsseldorf

Universitätsklinikum Düsseldorf, Düsseldorf

44892

University Clinics Bochum, Bochum

45147

University Clinics Essen, Essen

55131

University Clinics Johannes-Gutenberg Mainz, Mainz

60590

University Clinics Frankfurt, Frankfurt

69120

University Clinics Heidelberg, Heidelberg

72076

University Clinics Tübingen, Tübingen

79106

University Clinics Freiburg, Freiburg im Breisgau

81675

TUM, München

89081

Universitätsklinikum Ulm, Ulm

97080

University Clinics Würzburg, Würzburg

Unknown

Medizinische Universität Innsbruck, Innsbruck

Medizinische Universität Wien, Vienna

Wiener Gesundheitsverbund, Klinik Hietzing, Vienna

01307

University Clinics Carl Gustav Carus Dresden, Dresden

04103

Eugastro GmbH, Leipzig