Novo Nordisk Unveils New Phase 3 Trial for Obesity Drug CagriSema Amid Competitive Landscape

Novo Nordisk has announced plans for a new Phase 3 trial of its next-generation obesity drug CagriSema, aiming to refine dosing strategies and treatment duration. This move comes in response to underwhelming results from a previous late-stage study and intensifying competition in the weight loss medication market.

Redefine-11: A New Approach to CagriSema Testing

The Danish pharmaceutical giant revealed on Wednesday that the upcoming trial, dubbed Redefine-11, will explore different dosing regimens and extend the treatment period beyond the 68 weeks used in the initial Redefine-1 study. This decision follows a thorough analysis of data from Redefine-1, which yielded results below the company's expectations for weight loss efficacy.

In Redefine-1, participants receiving the highest dose of CagriSema experienced approximately 22% body weight loss, less than those on lower doses. The new trial aims to address this counterintuitive outcome by testing the high dose over a longer duration. Additionally, Redefine-11 will investigate the potential benefits of re-escalating doses for patients who initially reduced their intake due to gastrointestinal side effects.

Market Dynamics and Competitive Pressures

Novo Nordisk's strategic pivot with CagriSema comes amid fierce competition in the obesity treatment market, particularly from rival Eli Lilly. The landscape shifted significantly when Lilly's drug Zepbound demonstrated superior weight loss compared to Novo's established product, Wegovy, in a head-to-head trial. This development has placed increased scrutiny on Novo Nordisk's pipeline and market position.

Despite these challenges, Novo Nordisk reported robust financial performance for 2024, with total sales reaching 290 billion Danish kroner (approximately $42 billion), marking a 26% increase from the previous year. Notably, Wegovy sales surged to 58 billion kroner ($8.4 billion), representing an 86% year-over-year growth.

Implications for Future Development

The unexpected results from Redefine-1 have prompted analysts to question the relationship between dosing, efficacy, and side effects in CagriSema's development. Cantor Fitzgerald analyst Prakhar Agrawal described the data as "head-scratching," noting that the weight loss and side effect profiles did not align with typical dose-response patterns. This anomaly may be attributed to the rapid dose escalation employed in the initial Phase 3 trial.

As Novo Nordisk continues to refine its approach with Redefine-11, the company maintains its timeline for regulatory submission, with plans to seek approval for CagriSema in early 2026. The outcomes of this new trial and ongoing studies will be crucial in determining CagriSema's potential to compete effectively in the evolving obesity treatment market.