Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632444
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
LIVERAGE A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASHMASH Who Have Moderate or Advanced Liver Fibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Multicentre Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic SteatohepatitisMetabolic Associated Steatohepatitis NASHMASH and F2 - F3 Stage of Liver Fibrosis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is open to adults who are at least 18 years old and have
a confirmed liver disease called non-alcoholic steatohepatitis NASHmetabolic-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
a confirmed liver disease called non-alcoholic steatohepatitis NASHmetabolic-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None