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Novo’s CagriSema Falls Short of Lilly’s Tirzepatide in 84-Week Head‑to‑Head Trial

The setback reinforces Lilly’s advantage — Novo now targets higher doses with an FDA decision expected late 2026.

Overview

  • CagriSema produced about 23% average weight loss over 84 weeks versus 25.5% for tirzepatide, missing the study’s non‑inferiority goal.
  • Novo Nordisk shares sank roughly 15%–16% to their lowest since 2021 as billions in market value were erased, while Eli Lilly rose about 4%–5%.
  • Novo said the open‑label design may have favored the incumbent drug but maintained confidence in CagriSema’s profile and continued development.
  • The company has already filed CagriSema with the FDA, with a ruling expected late 2026, and plans additional phase III work including a high‑dose trial starting in the second half of 2026.
  • Analysts called the result a material commercial setback that strengthens Lilly’s lead and shifts investor focus to pricing, M&A options and Novo’s broader pipeline.