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Combined Active Treatment in Type 2 Diabetes with NASH

NCT04639414 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2024-10-10

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • German Center for Diabetes Research

    collaborator OTHER

  • Federal Ministry of Health, Germany

    collaborator OTHER_GOV

  • Ministry of Innovation, Science and Research in North Rhine-Westphalia

    collaborator UNKNOWN

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • German Diabetes Center

    lead OTHER

Principal Investigators

  • Michael Roden, Prof., MD · German Diabetes Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2025-01-31
Completion
2025-12-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639414 on ClinicalTrials.gov