After consistently failing to meet investor expectations, Novo Nordisk touted a safety profile for CagriSema in line with the GLP1-RA class, while reporting mid-stage data for its GLP1- and amylin-targeting drug amycretin that raised dosing questions.
After the underwhelming readout for CagriSema last December, Novo Nordisk came to the American Diabetes Association’s 85th scientific congress with new safety data for the drug, possibly hoping to rebuild investor confidence.
Also over the weekend, Novo revealed mid-stage data for its GLP-1- and amylin-targeting drug amycretin, leading to dose-related questions.
As for CagriSema, Novo on Sunday presented data from the REDEFINE-1 and REDEFINE-2 studies, which compared once-weekly subcutaneous injections of the trial drug versus placebo in more than 1,200 patients with type 2 diabetes and either obesity or overweight. Results from both studies were published simultaneously in The New England Journal of Medicine.
In REDEFINE-1, which focused on participants with obesity or those who were overweight but had at least one obesity-related complication, CagriSema resulted in a mean weight loss of 22.7% at 68 weeks. This mirrors its December 2024 readout—and continues to come slightly below the expectation of 25% weight reduction, which was set by the company itself.
Results for REDEFINE-2, which enrolled participants with type 2 diabetes, likewise reflected a March 2025 data drop, showing a 13.7% decrease in body weight at 68 weeks. Investors had been expecting at least a 15% reduction.
While the weight loss numbers failed to reach the company’s goals, Novo sees CagriSema’s competitive edge lying in its safety. The pharma said on Sunday that CagriSema’s side effect profile in REDEFINE-1 and REDEFINE-2 was “comparable with the GLP1-RA class,” noting that dropout rates were “low.” Both trials will continue to evaluate the safety of CagriSema.
“What people haven’t seen in detail yet is the side effect profile, as in, there will be a lot of comfort in that substantial weight loss potential,” said Martin Holst Lange, Novo’s executive vice president for development, according to reporting from The Financial Times.
Novo also recently launched the REDEFINE-11 study, which will evaluate CagriSema over a longer duration, the pharma revealed on Sunday.
Also at ADA 2025, and simultaneously published in The Lancet—Novo revealed Phase Ib/IIa data for amycretin, which it compared to placebo in 125 participants. Findings showed that a 60-mg subcutaneous dose of amycretin cut body weight by 24.3% after 36 weeks, while a 20-mg dose elicited a 22% weight loss.
After correcting for placebo-however, the 60-mg dose’s efficacy dipped slightly to 23.2%, while the 20-mg dose saw an efficacy bump to 23.2%—raising the question of which dose Novo should take forward into late-stage development.
The pharma announced on Friday that it is taking both the subcutaneous and oral formulations of amycretin into Phase III development, though it did not reveal the doses it plans to use.
