LIVERAGE™：中等度または進行した肝線維症を伴うNASH/MASHと呼ばれる肝疾患患者に対するスルボデュタイドの効果を検証する試験
基本情報
- NCT ID
- NCT06632444
- ステータス
- 募集中
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 1,800
- 治験依頼者名
- Boehringer Ingelheim
概要
This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.
対象疾患
介入
依頼者（Sponsor）
実施施設 (50)
JCHO Shimonoseki Medical Center
Shimonoseki, Japan(NOT_YET_RECRUITING)
佐賀大学医学部附属病院
Saga, Japan(RECRUITING)
独立行政法人国立病院機構長崎医療センター
Nagasaki, Omura, Japan(RECRUITING)
くまもと森都総合病院
Kumamoto, Kumamoto, Japan(RECRUITING)
National Hospital Organization Takasaki General Medical Center
Takasaki-shi, Japan(NOT_YET_RECRUITING)
Seichokai Bell Land General Hospital
Sakai, Japan(RECRUITING)
藤田医科大学病院
Aichi, Toyoake, Japan(NOT_YET_RECRUITING)
国家公務員共済組合連合会 虎の門病院
Tokyo, Minato-ku, Japan(RECRUITING)
国立大学法人島根大学医学部附属病院
Izumo, Japan(RECRUITING)
東北大学病院
Sendai, Japan(RECRUITING)
長野市民病院
Hanishina-gun, Japan(RECRUITING)
JCHO Shimonoseki Medical Center
Shimonoseki, Japan(NOT_YET_RECRUITING)
医療法人徳洲会 茅ヶ崎徳洲会病院
Sendai, Japan(RECRUITING)
新潟大学医歯学総合病院
Niigata, Japan(NOT_YET_RECRUITING)
和歌山県立医科大学附属病院
Wakayama, Japan(RECRUITING)
独立行政法人国立病院機構 九州医療センター
Fukuoka, Fukuoka, Japan(NOT_YET_RECRUITING)
聖マリアンナ医科大学病院
Kawasaki-shi, Japan(RECRUITING)
東海大学医学部付属病院
Isehara, Japan(RECRUITING)
独立行政法人労働者健康安全機構 大阪労災病院
Sakai, Japan(RECRUITING)
兵庫医科大学病院
Hyogo, Nishinomiya, Japan(RECRUITING)
国立研究開発法人国立国際医療研究センター 国府台病院
Chiba, Ichikawa, Japan(NOT_YET_RECRUITING)
久留米大学病院
Fukuoka, Kurume, Japan(RECRUITING)
京都府立医科大学附属病院
Kyoto, Kyoto, Japan(RECRUITING)
Seichokai Bell Land General Hospital
Sakai, Japan(RECRUITING)
熊本大学病院
Kumamoto, Japan(RECRUITING)
東京科学大学病院
Tokyo, Japan(NOT_YET_RECRUITING)
Sapporo Kosei General Hospital
Hokkaido, Sapporo, Japan(RECRUITING)
国立大学法人 三重大学医学部附属病院
Tsu, Japan(RECRUITING)
岐阜市民病院
Gifu, Gifu, Japan(NOT_YET_RECRUITING)
公立大学法人横浜市立大学附属病院
Yokohama, Japan(RECRUITING)
東京医科大学病院
Ibaraki, Inashiki-gun, Japan(RECRUITING)
信州大学医学部附属病院
Nagano, Matsumoto, Japan(RECRUITING)
社会福祉法人 恩賜財団 済生会支部 福井県済生会 福井県済生会病院
Fukui, Fukui, Japan(RECRUITING)
鹿児島大学病院
Kagoshima, Kagoshima, Japan(NOT_YET_RECRUITING)
宮崎大学医学部附属病院
Miyazaki, Miyazaki, Japan(RECRUITING)
Shin-yurigaoka General Hospital
Kanagawa, Kawasaki, Japan(RECRUITING)
医療法人 輝心会 大分循環器病院
Ōita, Japan(RECRUITING)
独立行政法人国立病院機構高崎総合医療センター
Takasaki-shi, Japan(NOT_YET_RECRUITING)
独立行政法人地域医療機能推進機構 北海道病院
Hokkaido, Sapporo, Japan(RECRUITING)
武蔵野赤十字病院
Musashino, Japan(NOT_YET_RECRUITING)
独立行政法人国立病院機構北海道がんセンター
Kure, Japan(RECRUITING)
Shin-yurigaoka General Hospital
Kanagawa, Kawasaki, Japan(RECRUITING)
広島大学病院
Hiroshima, Hiroshima, Japan(RECRUITING)
順天堂大学医学部附属静岡病院
Shizuoka, Izunokuni, Japan(RECRUITING)
公立大学法人 奈良県立医科大学附属病院
Nara, Kashihara, Japan(RECRUITING)
国立大学法人金沢大学附属病院
Ishikawa, Kanazawa, Japan(RECRUITING)
神戸大学医学部附属病院
Kobe, Japan(RECRUITING)
東京大学医学部附属病院
Bunkyō City, Japan(RECRUITING)
広島赤十字・原爆病院
Hiroshima, Japan(NOT_YET_RECRUITING)
日本医科大学付属病院
Tokyo, Bunkyo-ku, Japan(RECRUITING)