非アルコール性脂肪性肝炎（NASH）および線維化（F1～F3）を有する成人におけるスルボデュチド（BI456906）の安全性および有効性を検証する研究

基本情報

NCT ID

NCT04771273

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

295

治験依頼者名

Boehringer Ingelheim

概要

This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine. Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.

対象疾患

介入

依頼者（Sponsor）

実施施設 (21)