NCT04639414CompletedPhase 4
Combined Active Treatment in Type 2 Diabetes With NASH
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
The aim of this multicentre, prospective, placebo-controlled, double-blind, randomized, 3-arm parallel group, interventional study is to assess for the first time the effects of either a combined therapy with the antihyperglycemic drugs semaglutide and empagliflozin or empagliflozin monotherapy compared to placebo as potential treatments for non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 192 (actual)
- First submitted
- 5 Apr 2019
- Start date
- 26 Mar 2021
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- German Diabetes Center
- NCT number
- NCT04639414
- EudraCT number
- 2019-001987-31
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 192
- From 26 Mar 2021 to the primary completion date, 31 Jan 2025
- 25 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medications that may induce steatosis:tamoxifen, raloxifene, oral glucocorticoids or chloroquine
Other illness
- Liver disease of other etiology including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology
- History of ketoacidosis
Age
- Past (≥5 years) or current history of alcohol or drug abuse and/or psychiatric disease including severe depression necessitating pharmacological treatment
Other
- Contraindications on liver biopsy
- Evidence of cirrhosis on liver biopsy
- Alcohol consumption \>30 g/d for males and \>20 g/d for females
- Planned pregnancy, pregnant or lactating women, positive pregnancy test, and woman of childbearing potential not using two adequate methods of contraception, including a barrier method and a highly efficacious non-barrier method
Who the study is looking for
- Diagnosis of T2D and NASH with fibrosis stage F1-F3
- Age between 25 and 75 years
- HbA1c ≤ 9.5%
- obtained written informed consent
Age in the registry: 25 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universität Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Medizinische Universität Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Wiener Gesundheitsverbund, Klinik Landstraße Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Medizinische Universität Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Wiener Gesundheitsverbund - Klinik Hietzing Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Herz- und Diabeteszentrum NRW Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Unknown status |
| Leber- und Studienzentrum Checkpoint Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Franziskus-Krankenhaus Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| University Clinics Berlin Charité Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| University Clinics Bochum Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Städtisches Klinikum Brandenburg GmbH Coordinator of this site? Confirm its status | Brandenburg | Germany | Unknown status |
| Städtisches Klinikum Braunschweig gGmbH Coordinator of this site? Confirm its status | Braunschweig | Germany | Unknown status |
| University Clinics Carl Gustav Carus Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Universitätsklinikum Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| German Diabetes Center Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| University Clinics Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| University Clinics Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| University Clinics Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| University Clinics Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Eugastro GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| University Clinics Johannes-Gutenberg Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| TUM Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| University Clinics Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Universitätsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| University Clinics Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.