Combined Active Treatment in Type 2 Diabetes with NASH

NCT04639414 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing a combination of active treatments in adults with type 2 diabetes who also have non-alcoholic steatohepatitis (NASH) to see if it can improve liver health.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, triple-blind treatment study

Participants 192 people Planned (estimated).

Who can join Ages 25–75 · all sexes

Timeline Started 2021-03 · est. completion 2025-12

Where 26 sites · Austria, Germany

What this study is testing ClinicalTrials.gov NCT04639414 ↗

Description as written by the study sponsor.

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.

Treatments tested

Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector also known as Jardiance(R), Ozempic(R) Drug

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.
Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutide also known as Jardiance(R) Drug

Measurement of the effect of empagliflozin monotherapy 10mg/d compared to matching placebo after 48-week treatment.
Placebo matching empagliflozin and placebo pen injector matching semaglutide also known as Control / Placebo Drug

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.

Main thing measured	Histological resolution of NASH without worsening of fibrosis
Sponsor	German Diabetes Center
Conditions studied	Type 2 Diabetes, Non-alcoholic Steatohepatitis (NASH), Non-alcoholic Fatty Liver Disease (NAFLD)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04639414 ↗