Both Novo Nordisk and Eli Lilly are eyeing regulatory advancements for their obesity blockbusters as the European Association for the Study of Diabetes’ annual conference continues this week.
Obesity leaders Novo Nordisk and Eli Lilly could notch key expansions for their weight-loss products in the near future, further heating up an already-competitive field.
Speaking at the 2025 conference of the European Association for the Study of Diabetes, Novo’s chief scientific officer Martin Holst Lange said the Danish drugmaker is looking to submit a regulatory application for a high-dose formulation of Wegovy in the U.S., Bloomberg News reported on Tuesday. An application for the higher Wegovy dose was filed in Europe in July.
The high dose will enable Wegovy to go toe-to-toe with its chief competitor, Lilly’s Zepbound. “Obviously our competitors have optimized the dosing,” Lange told Bloomberg. “Now with high-dose Wegovy we’ve done the same.”
Novo tested 7.2-mg Wegovy against the currently approved 2.4-mg dose in the Phase IIIb STEP UP study, which enrolled more than 1,400 patients with obesity but not diabetes. A readout in January showed that those on the higher dose saw an 18.7% reduction in body weight at 72 weeks, whereas comparators on the standard dose achieved 15.6% weight loss.
Updated data presented at the 2025 American Diabetes Association’s meeting in June showed slightly better weight reduction figures across treatment arms, though the higher-dose injection remained numerically superior. Novo at the time also pointed to a “well-tolerated safety profile.” Adverse events were consistent with what is known for Wegovy and for the broader GLP-1 class.
Higher-dose Wegovy, if approved, could help Novo regain some lost ground against Lilly, which some analysts consider to have outmaneuvered the Danish pharma in the market. Novo has since parted ways with its former CEO Lars Fruergaard Jørgensen and replaced him with Maziar Mike Doustdar. Formerly the company’s executive vice president of internal operations, Doustdar said during the company’s second-quarter call that he will focus on execution.
Lilly will not easily be outdone, however. According to reporting from Reuters on Tuesday, which cited Wall Street analysts, the pharma’s investigational oral obesity drug orforglipron could potentially qualify for the FDA’s recently launched Commissioner’s Priority Voucher, which aims to shorten drug reviews to just one to two months, with a particular focus on companies that align with U.S. national policy priorities.
Quoting a recent note from Jefferies, Reuters noted that “orforglipron is a prime candidate for this pilot program as it treats a high-burden chronic condition and can be priced at parity.” In a statement, Lilly told the publication that while it thinks the FDA’s priority program is “promising,” it remains “too early” to say how the commissioner’s voucher will apply to its specific programs.
