Reducing Non-Alcoholic Steatohepatitis

Официальное название

Reducing Non-Alcoholic Steatohepatitis Study

Обзор

The goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults. The objectives are: Primary Objective To evaluate the change in histological grading and staging of NASH in patients with confirmed non-alcoholic steatohepatitis (NASH) treated with empagliflozin for a duration of 48 weeks. Secondary Objective To evaluate the change in findings from non-invasive liver elasticity measurements, laboratory tests, and anthropometric assessments after 48 weeks of empagliflozin administration. Participants will: Take empagliflozin every day for 12 months. Visit the clinic according to a protocol at weeks: 1, 2, 4, 12, 24, 36, 48 Visits includes checkups and tests (blood count, basic biochemistry, glycosylated hemoglobin, anthropometry, non-invasive liver stiffness measurement).

Вмешательства

• Препарат Empagliflozin 10 miligrams (mg)
  Use of empagliflozin 10 mg daily for 12 months.

Первичные конечные точки

• Change in histological activity after 12-month treatment with empagliflozin [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Change of liver stiffness [Срок оценки: 12 months]
• Change of liver steatosis [Срок оценки: 12 months]
• Anthropometry (body weight) [Срок оценки: 12 months]
• Anthropometry (height) [Срок оценки: 12 months]
• Anthropometry (BMI) [Срок оценки: 12 months]
• Liver functional tests [Срок оценки: 12 months]
• Bilirubin level [Срок оценки: 12 months]
• Lipidogram [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Ability and eligibility to provide informed consent.
• Age between 18 and 75 years at the time of study initiation.
• Confirmed or excluded diagnosis of type 2 diabetes mellitus (DM2) according to the target group (OGTT test, HbA1c).
• Diagnosis of NASH confirmed by a central pathologist based on histological evaluation of a liver biopsy performed within 3 months prior to the initiation of the investigational drug. - The evaluation must include determination of the process activity according to the NAFLD Activity Score (NAS).
• HbA1c value ≤ 80 mmol/mol.
• For women of childbearing potential, willingness to use at least two adequate methods of contraception.

Критерии исключения

• Contraindication to liver biopsy.
• Documented episode of ketoacidosis.
• Contraindication or hypersensitivity to empagliflozin.
• Presence of acute or chronic illness that, in the investigator's opinion, could jeopardize the health or safety of the patient.
• HbA1c value > 80 mmol/mol.
• Inability to safely discontinue thiazolidinedione (pioglitazone) therapy.
• Liver disease of other etiologies, including viral hepatitis B and C, autoimmune hepatitis, alpha-1 antitrypsin deficiency, hemochromatosis, Wilson's disease, primary sclerosing cholangitis, primary biliary cholangitis, or liver cirrhosis (Child-Pugh A, B, C) of any etiology.
• Use of medications or medical procedures that induce liver steatosis or fibrosis.
• Proven alcohol use exceeding: Men > 30 g/day, Women > 20 g/day.
• History of acute or chronic pancreatitis.
• Known dependence on or use of illegal addictive substances.
• Significant weight gain or loss: +/- 10% in the last three months.
• Diagnosis of malignant disease (except treated benign or skin tumors) in the last 5 years.
• Stroke or myocardial infarction in the last 6 months.
• Clinically significant dyspnea New York hear association (NYHA) grade III or higher.
• Proven heart failure with a left ventricular ejection fraction below 40%.
• estimated glomerular filtration rate(eGFR) values lower than 30 ml/min/1.73 m² or creatinine clearance lower than 30 ml/min.
• Proven diabetic foot syndrome requiring amputation or with an existing defect.
• Planned pregnancy, ongoing lactation or pregnancy, positive pregnancy test, lack of at least two adequate contraceptive methods in women of childbearing potential.
• Participation in another interventional study within the last 3 months before study entry.
• Legal incapacity or reduced ability to perform legal acts.
• Serving a prison sentence.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• Central Military Hospital — Prague

Идентификаторы

NCT: NCT06519448 · RedNASH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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