Novo Nordisk Defends Underwhelming CagriSema Trial Results, Calls It ‘An Important Product’

Novo Nordisk is standing by its next-generation obesity drug candidate, CagriSema, despite disappointing clinical trial results that sent its stock tumbling. The Danish pharmaceutical giant insists the treatment remains a valuable addition to its weight-loss portfolio.

CEO Addresses Shareholders

Speaking at the company’s Annual General Meeting in Copenhagen, CEO Lars Fruergaard Jørgensen acknowledged investor concerns after two consecutive late-stage trials failed to meet expectations. However, he expressed confidence in CagriSema’s potential.

“I’m very confident about CagriSema,” Jørgensen told shareholders. “It will be an important product for us.”

CagriSema combines cagrilintide—an amylin analog used in weight-loss treatments—with semaglutide, the active ingredient in Novo Nordisk’s blockbuster obesity drug, Wegovy.

Trial Results and Market Impact

The latest REDEFINE-2 Phase 3 trial showed that CagriSema helped obese or overweight adults with type 2 diabetes lose an average of 15.7% of their body weight over 68 weeks, compared to 3.1% for placebo. While significant, the results fell short of the high-teen percentage previously projected.

An earlier trial in December reported a 22.7% weight reduction in obese or overweight individuals with at least one comorbidity, excluding type 2 diabetes—also missing the expected 25% target.

Investor reaction was swift, with Novo Nordisk’s stock plunging more than 50% from its 2024 highs as hopes for a superior alternative to Wegovy and Eli Lilly’s Zepbound diminished.

Calls for Better Communication and Strategy

Shareholders pressed Novo Nordisk’s leadership for clearer trial designs and projections to avoid such market volatility. Jørgensen admitted the company could have done a better job communicating the trial’s flexibility, particularly regarding patient tolerability.

“22.7% is not 25%, so some people were disappointed about that,” he acknowledged, but emphasized that the firm sees continued potential for CagriSema. The company is now exploring extended trial periods and dosage adjustments.

To further evaluate CagriSema’s efficacy, Novo Nordisk has launched REDEFINE 11, a new Phase 3 trial aimed at addressing concerns and refining its approach.

A Shifting Weight-Loss Market

The broader weight-loss industry remains divided over obesity drug applications beyond total weight reduction. Analysts at BofA Global Research recently expressed “slightly more cautious” views on the differentiation of obesity and diabetes treatments following the latest CagriSema results.

However, some experts argue that a range of treatments is necessary to address diverse patient needs, including cardiovascular disease, sleep apnea, and liver disease.

“It’s clear that there is a very large market opportunity, but it also takes a portfolio of products that cater to different patient needs,” Jørgensen noted.

As Novo Nordisk refines its strategy, the global weight-loss drug market remains a battleground, with competitors racing to develop more effective and well-tolerated solutions.