A Master Protocol for Semaglutide Effects on Cardiovascular and Obesity-related Outcomes in People With Overweight or Obesity in the Real World

Launched by NOVO NORDISK A/S ·

Keywords

ClinConnect Summary

This is a large, real-world study looking at whether once-weekly semaglutide affects heart and other obesity-related health outcomes. Researchers will use medical and pharmacy records from people in the United States (2016–2024) to compare adults who start semaglutide with similar adults who do not use the drug. The study groups include people with heart failure, people with existing atherosclerotic cardiovascular disease (ASCVD), and people at risk for ASCVD but without established disease. The main focus is on cardiovascular events such as heart attack, stroke, hospitalization for heart failure, heart-related procedures, and death, followed over up to about 3½ years.

To be eligible, people need to be 45 years or older and have overweight or obesity (a BMI of 27 or higher, with related medical indications). They must have continuous insurance coverage for at least 12 months before joining, and not have certain conditions like pancreatitis, specific cancers, end-stage kidney disease, pregnancy, diabetes, or prior bariatric surgery. Participants will be observed as either semaglutide users (those who started the medicine after eligibility) or non-users (no semaglutide). Because this is an observational study, it will show associations rather than proving that semaglutide causes any outcome. No results are available yet.

Gender

ALL

Eligibility criteria