Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214741
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-01-10
Brief Title:
A Study to Test Whether Survodutide BI 456906 Helps Chinese People Living With Overweight or Obesity to Lose Weight
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase III Randomized Double-blind Parallel-group Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Chinese Participants With a BMI 28 kgm2 or BMI 24 kgm2 With at Least One Weight-related Complication
Status:
RECRUITING
Status Verified Date:
2024-08
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 in China is open to adults who are at least 18 years old who are living with overweight or obesity People with a body mass index BMI of 28 kgm2 or higher or 24 kgm2 or higher with at least 1 weight related problem can join the study The main purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity 2 different doses of survodutide are tested in this study
Participants are put into 3 groups by chance Each participant has an equal chance of being in each group 2 groups get different doses of survodutide 1 group gets placebo Participants get survodutide or placebo as injections under the skin once a week for about 19 months
Placebo injections look like survodutide injections but do not contain any medicine
Participants are in the study for about 21 months During this time there are 20 visits 14 visits are in person at the study site Where possible 6 visits can be done by video call or by phone in rare cases During this time doctors regularly measure participants body weight Results are compared between the survodutide groups and placebo group to see whether the treatment works The doctors also regularly check participants health and take note of any unwanted effects
Participants are put into 3 groups by chance Each participant has an equal chance of being in each group 2 groups get different doses of survodutide 1 group gets placebo Participants get survodutide or placebo as injections under the skin once a week for about 19 months
Placebo injections look like survodutide injections but do not contain any medicine
Participants are in the study for about 21 months During this time there are 20 visits 14 visits are in person at the study site Where possible 6 visits can be done by video call or by phone in rare cases During this time doctors regularly measure participants body weight Results are compared between the survodutide groups and placebo group to see whether the treatment works The doctors also regularly check participants health and take 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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1295-9567 | REGISTRY | WHO International Clinical Trials Registry Platform ICTRP | None |