drugset / Trial / NCT04639414
Combined Active Treatment in Type 2 Diabetes With NASH
Phase 4
Completed
192 enrolled
German Diabetes Center
Boehringer Ingelheim · collabFederal Ministry of Health, Germany · collabGerman Center for Diabetes Research · collabMinistry of Innovation, Science and Research in North Rhine-Westphalia · collabNovo Nordisk A/S · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2021-03-26
- Primary completion
- 2025-01-31
- Completion
- 2025-11-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Semaglutide | Peptide | 1 mg | — |