TLDR
- Novo Nordisk shares plummeted 15% following disappointing CagriSema trial results that couldn’t demonstrate non-inferiority against Eli Lilly’s tirzepatide.
- Trial participants taking CagriSema achieved 23% weight reduction compared to 25.5% with tirzepatide — falling short of the study’s main goal.
- NVO shares reached their weakest point since June 2021, declining approximately 50% from their peak over 12 months.
- Company leadership maintains optimism about CagriSema’s prospects, emphasizing its unique position as a pioneering GLP-1/amylin combination therapy.
- Eli Lilly shares gained 3.1% during premarket hours following the announcement.
Novo Nordisk suffered a significant blow this Monday. Shares tumbled as much as 15% following the pharmaceutical giant’s disclosure that CagriSema, its next-generation obesity treatment, couldn’t demonstrate equivalency to Eli Lilly’s tirzepatide in a direct comparison study.
The disappointing outcome pushed NVO shares to their weakest level in nearly four years.
According to the late-stage clinical study data, participants receiving CagriSema experienced a 23% reduction in body weight after 84 weeks of treatment. In contrast, those administered tirzepatide — the key compound in Lilly’s Mounjaro and Zepbound medications — achieved a 25.5% weight reduction.
This performance difference resulted in CagriSema failing to meet its primary objective: demonstrating non-inferiority compared to tirzepatide.
Researchers conducted the study as an open-label trial, which means participants were aware of which medication they received. Novo’s Chief Scientific Officer Martin Holst Lange acknowledged that this trial structure could potentially skew results in favor of established medications when compared against investigational compounds.
Lange expressed being “surprised” by the 25.5% efficacy observed with tirzepatide, noting that Lilly’s previous research demonstrated approximately 20.2% weight reduction over 72 weeks.
CEO Stays Optimistic
Confronting the disappointing data, CEO Mike Doustdar maintained a confident stance. “We strongly believe that CagriSema has, right now, the best weight efficacy than any product currently in the market,” he stated.
Novo submitted CagriSema for FDA review in late 2024, with regulatory feedback anticipated by late 2026. Doustdar projected market entry could occur early next year, positioning it as having the most effective weight-loss indication available.
The pharmaceutical company is considering supplementary clinical trials, including evaluations of higher-dose formulations, to fully realize the medication’s therapeutic potential.
CagriSema represents a combination of semaglutide — the active component in Ozempic and Wegovy — paired with cagrilintide, an investigational hormone that modulates appetite. Novo has marketed it as the inaugural GLP-1/amylin dual-mechanism treatment for obesity management.
A Rough Run for Novo
This setback doesn’t stand alone. When Novo initially unveiled CagriSema late-stage trial results in December 2024, shares dropped 21%, erasing roughly $100 billion in market capitalization.
Throughout the last twelve months, NVO has surrendered nearly half its stock value.
Earlier in the month, Novo projected a revenue and earnings contraction ranging from 5% to 13% for 2026. The company faces mounting challenges from intensifying market competition, reduced pricing in the United States, and approaching patent cliff concerns for Wegovy and Ozempic in certain territories.
Jefferies analyst Michael Leuchten observed that CagriSema’s market positioning has become “increasingly unclear” in light of Monday’s data release. He projected the medication could represent 15% to 25% of Novo’s total revenue by 2030 and emphasized “the pressing need for M&A,” predicting Novo might deploy up to $35 billion toward strategic acquisitions during the current year.
In contrast, Eli Lilly’s shares climbed 3.1% during Monday’s premarket session.
Novo’s Copenhagen-traded shares were most recently down 14% at 259 Danish kroner.
