Combined Active Treatment in Type 2 Diabetes With NASH
- Status
- CompletedResults none
- Why it is watched
- non-weight indication: liver, addiction
- Who it enrolls
- age 25 Years to 75 Years; no BMI minimum stated; conditions: Type 2 Diabetes; Non-alcoholic Steatohepatitis (NASH); Non-alcoholic Fatty Liver Disease (NAFLD)
- Interventions
- Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector; Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutide; Placebo matching empagliflozin and placebo pen injector matching semaglutide
- Conditions
- Type 2 Diabetes; Non-alcoholic Steatohepatitis (NASH); Non-alcoholic Fatty Liver Disease (NAFLD)
- Phase and size
- Phase 4 · 192 participants
- Dates
- Start 2021-03-26
Primary completion 2025-01-31 - Sponsor
- German Diabetes Center (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Histological resolution of NASH without worsening of fibrosisfrom baseline to 48 weeks
02Eligibility
Who can take part
Inclusion Criteria: * Diagnosis of T2D and NASH with fibrosis stage F1-F3 * Age between 25 and 75 years * HbA1c ≤ 9.5% * obtained written informed consent Exclusion Criteria: * Contraindications on liver biopsy * Evidence of cirrhosis on liver biopsy * 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 * Alcohol consumption \>30 g/d for males and \>20 g/d for females * Past (≥5 years) or current history of alcohol or drug abuse and/or psychiatric disease including severe depression necessitating pharmacological treatment * Medications that may induce steatosis:tamoxifen, raloxifene, oral glucocorticoids or chloroquine * 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
03Change log
Registry changes
No changes recorded since the trial was added.