Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077864
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-09-27
Brief Title:
A Study to Test the Effect of Survodutide BI 456906 on Cardiovascular Safety in People With Overweight or Obesity SYNCHRONIZE - CVOT
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase 3 Randomised Double-blind Parallel-group Event-driven Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease CVD or Chronic Kidney Disease andor at Least Two Weight-related Complications or Risk Factors for CVD
Status:
RECRUITING
Status Verified Date:
2024-10
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 a body mass index BMIbof 27 kgm2 or more People can take part if they have cardiovascular or chronic kidney disease People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate Participants must have previously tried to lose weight by changing their diet
The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide BI 456906 are less or more likely to develop serious cardiovascular problems It also aims to find out whether health parameters like blood pressure improve Overweight and obesity are linked to cardiovascular disease Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight
Participants are divided into 3 groups of almost equal size 2 groups get 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 inject survodutide or placebo under the skin once a week All participants also receive counselling on diet and physical activity
Participants are in the study for up to 2 years and 3 months During this time it is planned that participants visit the study site up to 21 times and attend remote visits by video calls During these visits the doctors check participants cardiovascular and overall health The results are compared between survodutide and placebo groups The study staff also takes note of any unwanted effects
The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide BI 456906 are less or more likely to develop serious cardiovascular problems It also aims to find out whether health parameters like blood pressure improve Overweight and obesity are linked to cardiovascular disease Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight
Participants are divided into 3 groups of almost equal size 2 groups get 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 inject survodutide or placebo under the skin once a week All participants also receive counselling on diet and physical activity
Participants are in the study for up to 2 years and 3 months During this time it is planned that participants visit the study site up to 21 times and attend remote visits by video calls During these visits the doctors check participants cardiovascular and overall health The results are compared between survodutide and placebo groups The study staff also takes note of any unwanted effects
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 |
|---|---|---|---|
| 2022-502442-27-00 | REGISTRY | None | None |
| U1111-1289-0174 | REGISTRY | WHO registry | None |