Reducing Non-Alcoholic Steatohepatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2024-10-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha

External identifiers

EU CT number

2024-518334-88-00

EudraCT number

2023-000041-16

ClinicalTrials.gov

NCT06519448

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Evaluation of histological grade and NASH stage in patients with verified NASH during 48-week long empagliflozin therapy.

Secondary objectives 1

1. Evaluation of changes in non-invasive liver elastography, laboratory results and anthropometric data during 48-week long empagliflozin therapy

Conditions and MedDRA coding

Metabolic dysfunction-associated steatohepatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • The ability and eligibility to sign informed consent. • The age between 18 and 75 years of age at the beginning of the study. • Verified/excluded diagnosis of DM2T according to the cohort. (OGTT HbA1c). Verified diagnosis of NASH determined by histology no older than 6 months before the administration of medication. The activity of the process must be determined by NAFLD Activity Score – NAS. • Value of HbA1c ≤ 80 mmol/mol. • In women of child bearing age a willingness to use at least 2 contraceptive methods

Exclusion criteria 1

1. • Contraindication of liver biopsy • A documented episode of ketoacidosis • Contraindication or hypersensitivity to empagliflozin • A presence of an acute or chronic disease that could endanger the safety or health of the patient by discretion of the examiner • Value of HbA1c > 80 mmol/mol. • The inability to exclude thiazolidinedione (pioglitazone) from chronic medication. • Liver affection of different etiology, including hepatitis B a C , autoimmune hepatitis, alpha-1 antitrypsin insufficiency, hemochromatosis, Wilson disease, primary sclerosing cholangitis, primary biliary cirrhosis or liver cirrhosis (Child-Pugh A, B, C) of any etiology • The use of drugs or medicine inducing steatosis or liver fibrosis. • Verified use of ethanol: men >30 g/day, woman > 20 g/day • History of acute o chronic pancreatitis. • Known abuse of and or an addiction to illegal substances • A verified fluctuation of body weight +/- 10 % in the last 3 months. • A diagnosis of a malignant disease (with the exclusion of threated dermal malignancies) in the last 5 years. • Cerebral stroke or cardiac infarction in the last 6 months. • Clinically significant shortness of breath defined as NYHA III or more. • Verified heart failure with associated decrease of ejection fraction of the left ventricle less than 40 %. • Values of eGFR lower than 30 ml/min/1,73 m2 or if CrCl is lower than 30 ml/min. • Syndrome of the diabetic foot with the need for amputation or an active ulcer • Planed pregnancy, active lactation or pregnancy, positivity in a pregnancy test, absence of at least 2 adequate contraceptive methods in women of fertile age. • Participation in a different study in the last 3 months before the start of the study. • Incapacity or diminished capacity to perform legal acts. • Pending execution of a sentence.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Decrease of a histological score of NASH

Secondary endpoints 1

1. Decrease of fibrosis stage assessed by non-invasive liver elastography. Improvement of laboratory results and anthropometric data

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha

Sponsor organisation

Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha

Address

U Vojenske Nemocnice 1200

City

Prague 6

Postcode

169 02

Country

Czechia

Scientific contact point

Organisation

Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha

Contact name

Investigator

Public contact point

Organisation

Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha

Contact name

Investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications