Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

Type 2 DiabetesNon-alcoholic Steatohepatitis (NASH)Non-alcoholic Fatty Liver Disease (NAFLD)Fatty liverDiabetes mellitusEmpagliflozinSemaglutide

Outcome Measures

Primary Outcomes (1)

Histological resolution of NASH without worsening of fibrosis
NAFLD status will be assessed by histologic evaluation of liver biopsy samples based on NAFLD activity score. NASH resolution is defined by disappearance of ballooning (score 0), together with either disappearance of lobular inflammation or the persistence of mild lobular inflammation only (score 0 or 1) and resulting in an overall pathologic diagnosis of either steatosis alone or steatosis with mild inflammation; with no worsening of fibrosis. Worsening of fibrosis is defined by an increase of at least one stage of the Kleiner fibrosis classification.
from baseline to 48 weeks

Secondary Outcomes (4)

Overall NAFLD activity score (NAS)
from baseline to 48 weeks

Study Arms (3)

Combined treatment with Empagliflozin and Semaglutide

EXPERIMENTAL

Combined treatment with Empagliflozin, film-coated tablet, 10mg once daily and Semaglutide, colourless solution in pre-filled pen, 1mg once weekly

Drug: Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector

Empagliflozin monotherapy

EXPERIMENTAL

Empagliflozin, film-coated tablet, 10mg once daily and Placebo matching Semaglutide (colourless solution in pre-filled pen, once weekly)

Drug: Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutide

Placebo

PLACEBO COMPARATOR

Interventions

Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injectorDrug

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.

Also known as: Jardiance(R), Ozempic(R)

Combined treatment with Empagliflozin and Semaglutide

Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutideDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age25 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of T2D and NASH with fibrosis stage F1-F3
Age between 25 and 75 years

Sponsors & Collaborators

Ministry of Innovation, Science and Research in North Rhine-Westphalia
Type not reportedcollaborator
Federal Ministry of Health, Germany
Governmentcollaborator

Study Sites (26)

Medizinische Universität Graz

Graz, 8010, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Wiener Gesundheitsverbund, Klinik Landstraße

Vienna, 1030, Austria

Medizinische Universität Wien

Vienna, Austria

Wiener Gesundheitsverbund, Klinik Hietzing

Vienna, Austria

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver DiseaseFatty LiverDiabetes Mellitus

Interventions

empagliflozinTabletssemaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Study Officials

Michael Roden, Prof., MD
German Diabetes Center
PRINCIPAL INVESTIGATOR

Enrollment

192 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: double-blind placebo-controlled
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

November 20, 2020

Study Start

March 26, 2021

Actual (reported)

Combined Active Treatment in Type 2 Diabetes With NASH

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Combined treatment with Empagliflozin and Semaglutide

Empagliflozin monotherapy

Placebo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Combined treatment with Empagliflozin and Semaglutide

Empagliflozin monotherapy

Placebo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations