Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352437
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-04-03
Brief Title:
A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Safety Tolerability and Pharmacokinetics of Single Subcutaneous Doses of BI 3034701 in Healthy Male Volunteers Part A and of Multiple Rising Subcutaneous Doses in Otherwise Healthy Male and Female Volunteers With ObesityOverweight Part B
Status:
RECRUITING
Status Verified Date:
2024-06
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 healthy people and people with overweight or obesity It has 2 parts Part A is open to healthy men between 18 and 55 years of age Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy
The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men Part A and people with overweight or obesity Part B Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood
Participants get different doses of BI 3034701 or placebo as an injection under the skin In Part A every participant gets a single dose In Part B every participant gets several doses of BI 3034701 or placebo In this study BI 3034701 is given to humans for the first time
Participants in Part A are in the study up to 10 weeks During this time they visit the study site 8 times Participants in Part B are in the study for about 6 months They visit the study regularly At some of the visits participants in both parts stay at the study site for up to 5 nights During the study the doctors collect information on any health problems of the participants
The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men Part A and people with overweight or obesity Part B Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood
Participants get different doses of BI 3034701 or placebo as an injection under the skin In Part A every participant gets a single dose In Part B every participant gets several doses of BI 3034701 or placebo In this study BI 3034701 is given to humans for the first time
Participants in Part A are in the study up to 10 weeks During this time they visit the study site 8 times Participants in Part B are in the study for about 6 months They visit the study regularly At some of the visits participants in both parts stay at the study site for up to 5 nights During the study the doctors collect information on any health problems of the participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| U1111-1302-5933 | REGISTRY | WHO International Clinical Trials Registry Platform ICTRP | None |
| 2023-508767-79-00 | REGISTRY | None | None |