A Study to Test the Effect of BI 456906 on Cardiovascular Safety in People With Overweight or Obesity

JRCT ID: jRCT2031230478

Registered date:25/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 18/12/2023
• Target sample size: 4935
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Italy,Japan,Kazakhstan,Japan,Korea, Republic of,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Saudi Arabia,Japan,Slovakia,Japan,South Africa,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

Drug: BI 456906
Drug: Placebo

Outcome(s)

• Primary Outcome: Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 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.
2. Body mass index (BMI)>=27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI >=30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.

Exclude criteria

1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1)agonists within 3 months before screening.
2. Type 1 diabetes.
3. Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP)combinations and screening.
4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).

Related Information

• Primary Sponsor: Yamamoto Machiko
• Secondary ID(s): NCT06077864