NCT04639414

Combined Active Treatment in Type 2 Diabetes with NASH

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: German Diabetes Center · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Obesity and type 2 diabetes (T2D) are tightly associated with non-alcoholic fatty liver disease (NAFLD), which in turn predicts the development of T2D and cardiovascular disease. Up to 80% of NAFLD patients with T2D have NASH and the presence of T2D is an independent risk factor for more-advanced fibrosis, higher rate of fibrosis progression, and increased mortality. Liver-related mortality is increased 10-fold in NASH patients compared with the general population. In addition, people with NASH are at an excessive risk of cardiovascular morbidity and mortality. Currently, there are no established pharmacotherapies for NASH patients with T2D. The aim of this trial is to evaluate efficacy of a combined treatment with semaglutide 1 mg/week (GLP1RA) and empagliflozin 10 mg/d (SGLT2I) or ii) empagliflozin 10 mg/d monotherapy by means of histological resolution of NASH in T2D patients without progression of fibrosis after 48 weeks treatment. To confirm a histological diagnosis of NASH and proof efficacy of treatment, a liver biopsy will be performed prior to screening as well as at the end of treatment phase.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-26
• Primary completion: 2025-01-31
• Completion: 2025-12-01
• First posted: 2020-11-20
• Last updated: 2024-10-10

Locations

26 sites across 2 countries: Austria, Germany