Real-world use and effectiveness of tirzepatide among individuals without type 2 diabetes: Results from the Optum Market Clarity database.

AIMS: To understand real-world tirzepatide utilization and effectiveness (change in weight and body mass index [BMI]) among people without type 2 diabetes (T2D) in the United States. MATERIALS AND METHODS: This retrospective, observational study used Optum's de-identified Market Clarity database (index date: first-observed tirzepatide claim; index period: 13 May 2022-30 September 2023). Outcomes were assessed in 3 cohorts: (1) Overall cohort: age ≥18 years; ≥1 tirzepatide claim; no baseline T2D diagnosis codes, anti-diabetes medication use (except metformin) or glycated haemoglobin ≥6.5%; continuous medical and pharmacy enrolment for ≥12 months pre-index. (2) Utilization cohort: all above criteria and anti-obesity medication (AOM)-eligible individuals (BMI ≥30 kg/m, or ≥27 kg/m with ≥1 obesity-related complication [ORC]) for assessment of tirzepatide utilization (persistence, discontinuation, dose escalation and switching 6 months post-index). (3) Effectiveness cohort: all above criteria and AOM-eligible glucagon-like peptide-1 receptor agonist (GLP-1 RA)-naive individuals persistent on tirzepatide for ≥6 months with pre- and post-index weight and BMI measurements for assessment of tirzepatide effectiveness (mean absolute and percent bodyweight/BMI change from baseline and bodyweight/BMI reduction ≥5%, ≥10%, ≥15% and ≥20%). All analyses were descriptive. RESULTS: Overall cohort included 20,998 individuals (mean age: 47.4 years, female: 74.9%, mean BMI: 36.9 kg/m). At index, 66.0% of individuals had ≥1 ORC, while 44.4% had ≥2 ORCs. Persistence in the utilization cohort was 55.4%; 30.8% switched to a different AOM/GLP-1 RA analogue or restarted tirzepatide after discontinuation, and by the sixth prescription fill, 74.2% were on <10 mg tirzepatide. Mean weight reduction in the effectiveness cohort was 11.9% at 6 months post-index (≥5%: 85.8%; ≥10%: 61.5%). CONCLUSIONS: Real-world evidence suggests multimorbidity is common among tirzepatide initiators. While tirzepatide dose escalation was slower than in clinical trials, individuals achieved weight reduction at 6 months, consistent with clinical trials.