Predicting Long-Term Outcome Risk with Tirzepatide: A Post-Hoc Analysis of SURMOUNT-1

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Study drug and medical condition

• Medical condition to be studied:
  Obesity

  Type 2 diabetes mellitus

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  2500

Study design details

• Main study objective:
  To describe and compare the change from baseline predicted risk of long-term outcomes (listed below) between tirzepatide and placebo at 72 weeks among people with overweight or obesity using SURMOUNT-1 trial data. -Atherosclerotic Cardiovascular Disease -Type 2 diabetes
• Outcomes:
  Predicted risk for cardiovascular disease and predicted risk for type 2 diabetes
• Data analysis plan:
  The primary analysis will use the American College of Cardiology/American Heart Association (ACC/AHA) risk engine to calculate CVD risk scores and the Cardiometabolic Disease Staging (CMDS) engine to calculate T2D risk scores. Risk scores will be calculated at baseline and Week 24 and Week 72 as well as the change of risk score from baseline.