BridgeMD
A study to test the effect of BI 456906 on cardiovascular safety in people with overweight or obesity
EU CTIS ID: 2022-502442-27-00
What this study is testing
The primary objective is to demonstrate non-inferiority of survodutide compared with placebo by means of the hazard ratio (survodutide vs. placebo) based on a Cox regression for time to first occurrence of any of the adjudicated components of the primary composite endpoint, defined as CV death, non-fatal stroke, non-fatal myocardial infarction (MI), ischaemia related coronary revascularisation, or heart failure events (HFE) (5P-MACE).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- BMI ≥27 kg/m2 at screening with either established CVD or with at least 2 weight-related complications or risk factors for CVD, or a combination of both OR BMI ≥30 kg/m2 at screening with either established CVD or CKD, or with at least 2 weight-related complications or risk factors for CVD, or any combination of these
- Further inclusion criteria apply
You likely can't join if
- Previous treatment with GLP-1R agonists within 3 months before screening
- Type 1 diabetes
- Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/GIP combinations and screening
- Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction)
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Saudi Arabia
- Mexico
- Hong Kong
- Brazil
- United States
- Taiwan
- Argentina
- India
- China
- Japan
- Turkey
- Korea, Republic of
- Australia
- Kazakhstan
- United Kingdom
- Canada
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saudi Arabia; Mexico; Hong Kong; Brazil; United States; Taiwan and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.