Ignite Creation Date:
2024-07-17 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492135
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Safety Tolerability and Pharmacokinetics Study of Multiple Rising Subcutaneous Doses of Survodutide in Chinese Participants With Overweight or Obesity BMI 240 to 400 kgm2 Non-randomization Open Label Parallel Group Design
Status:
ACTIVE_NOT_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 Chinese adults aged 18 to 60 with overweight or obesity People can join the study if they have a Body Mass Index from 24 to 400 kgm2
Survodutide is a medicine being developed to help people with overweight or obesity The purpose of this study is to find out how different doses of survodutide are taken up in the body Other goals are to test if participants can tolerate different doses of survodutide and whether survodutide helps people with overweight or obesity
Participants receive survodutide as an injection under the skin once a week for 75 months During this time participants visit the study site 33 times 4 of the visits require a stay in the hospital At the visits doctors take blood samples to measure the levels of survodutide in participants blood The doctors also check participants health and take note of any unwanted effects
Survodutide is a medicine being developed to help people with overweight or obesity The purpose of this study is to find out how different doses of survodutide are taken up in the body Other goals are to test if participants can tolerate different doses of survodutide and whether survodutide helps people with overweight or obesity
Participants receive survodutide as an injection under the skin once a week for 75 months During this time participants visit the study site 33 times 4 of the visits require a stay in the hospital At the visits doctors take blood samples to measure the levels of survodutide in participants blood The doctors also 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