Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632457
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
LIVERAGE - Cirrhosis A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASHMASH Who Have Cirrhosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Double-blind Randomised Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic SteatohepatitisMetabolic Dysfunction Associated Steatohepatitis NASHMASH Cirrhosis
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 NASH or
A confirmed liver disease called metabolic-associated steatohepatitis MASH
BMI of 27 kgm2 or more or
25 kgm2 or more if the participant is Asian
People with a history of other chronic liver diseases or high 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 NASH or MASH improve their 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 All participants regularly receive counselling to make changes to their diet and to exercise regularly
Participants are in the study for up to 4 and a half years During this time they visit the study site or have a remote visit by video call every 2 4 or 6 weeks for about a 1 year and 5 months After this time participants visit the trial site or have 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 is regularly measured At some visits the liver parameters are measured using different imaging methods The participants also fill in questionnaires about their symptoms The results are compared between the groups to see whether the treatment works
A confirmed liver disease called non-alcoholic steatohepatitis NASH or
A confirmed liver disease called metabolic-associated steatohepatitis MASH
BMI of 27 kgm2 or more or
25 kgm2 or more if the participant is Asian
People with a history of other chronic liver diseases or high 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 NASH or MASH improve their 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 All participants regularly receive counselling to make changes to their diet and to exercise regularly
Participants are in the study for up to 4 and a half years During this time they visit the study site or have a remote visit by video call every 2 4 or 6 weeks for about a 1 year and 5 months After this time participants visit the trial site or have 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 is regularly measured At some visits the liver parameters are measured using different imaging methods The participants also fill in questionnaires about their symptoms 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