Eligibility for Semaglutide 2.4 mg in US Adults with Obesity and Prediabetes, Based on the STEP-10 Trial Criteria

Abstract

The STEP-10 trial among adults with obesity and prediabetes found that Wegovy led to greater reversion to normoglycemia and prevention of type 2 diabetes than placebo. The extent to which STEP-10 findings may be generalized to the US population with obesity and prediabetes is unclear. Therefore, we estimated the size and sociodemographic and metabolic characteristics of the US population that would be eligible for Wegovy based on STEP-10 criteria. We used the National Health and Nutrition Examination Survey from January 2017 to March 2020. Our sample included adults (aged ≥18) with a documented BMI and FPG. Those eligible for STEP-10 were defined as not receiving anti-diabetes or anti-obesity medication in the past month and having obesity (BMI ≥30 kg/m2) and prediabetes, defined as 6.0% ≤ HbA1c ≤ 6.4% or 99 mg/dL ≤ FPG ≤ 125 mg/dL. The study sample included 3,892 participants aged ≥18, representing 245,418,973 adults. Among this population, 20.4% (95% CI, 18.0-22.8%) or 49.9 million people were eligible for Wegovy based on STEP-10 criteria. Compared to the US population with obesity and prediabetes, STEP-10 overrepresented females and people of White race and enrolled participants with greater mean body weight, BMI, waist circumference, and HbA1c. These findings indicate that there is a large US population with non-medically treated obesity and prediabetes who could benefit from the type 2 diabetes preventative effects of Wegovy. However, the generalizability of STEP-10 to the US is limited by under-representation of Males and people of Black and Hispanic race/ethnicity.