Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309992
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-08
Brief Title:
A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis NASH to Reduce Liver Fat and to Lose Weight
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Multicentre Randomised Double-blind Placebo-controlled 48-week Phase III Trial to Evaluate the Efficacy and Safety of Survodutide Administered Subcutaneously in Participants With Overweight or Obesity and Presumed or Confirmed Nonalcoholic Steatohepatitis NASH
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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
presumed or confirmed NASH together with overweight or obesity and
a body mass index BMI of 30 kgm² or more or
a BMI of 27 kgm² and at least one weight-related health problem
People with a history of other chronic liver diseases cannot take part in this study
The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis NASH to have less liver fat and to lose weight Participants are put into 2 groups randomly which means by chance 1 group gets different doses of survodutide and 1 group gets placebo Placebo looks like survodutide but does not contain any medicine Every participant has a 2 in 3 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 for about 1 year In addition to the study medicine all participants receive counselling to make changes to their diet and to exercise regularly
Participants are in the study for about 1 year and 3 months During this time it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff The doctors check participants health and take note of any unwanted effects The participants body weight is regularly measured At 3 of the visits the participants liver is measured using different imaging methods The results are compared between the groups to see whether the treatment works
presumed or confirmed NASH together with overweight or obesity and
a body mass index BMI of 30 kgm² or more or
a BMI of 27 kgm² and at least one weight-related health problem
People with a history of other chronic liver diseases cannot take part in this study
The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis NASH to have less liver fat and to lose weight Participants are put into 2 groups randomly which means by chance 1 group gets different doses of survodutide and 1 group gets placebo Placebo looks like survodutide but does not contain any medicine Every participant has a 2 in 3 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 for about 1 year In addition to the study medicine all participants receive counselling to make changes to their diet and to exercise regularly
Participants are in the study for about 1 year and 3 months During this time it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff The doctors check participants health and take note of any unwanted effects The participants body weight is regularly measured At 3 of the visits the participants liver is measured using different imaging methods 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?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505303-23-00 | REGISTRY | None | None |
| U1111-1299-9925 | REGISTRY | WHO registry | None |