Study Limitations and Data Access

The study's limitations included being conducted only in the United States, having a predominantly white population, lacking a comparator arm continuing injectable therapy, and lasting one year. Deaths, pancreatic adverse events, and cardiovascular events were adjudicated by a blinded independent external committee. Rescue therapy protected participants but prevented a pure placebo comparison after week 24. Eli Lilly funded the study and was involved in design, data collection, analysis, interpretation, and writing. Lilly states it will provide anonymized individual participant data after specified regulatory and publication milestones, subject to review approval and a data-sharing agreement.