Novo Nordisk is progressing both subcutaneous and oral versions of amycretin into Phase III trials for patients with obesity and who are overweight.
Following a positive end-of-Phase II meeting, Novo Nordisk shared that regulatory authorities have approved the therapy to proceed. The company plans to initiate the trial in adults who are overweight or with obesity in Q1 2026.
Go deeper with GlobalData
Executive vice president for development at Novo Nordisk, Martin Lange said: “We are very pleased that the feedback from regulatory authorities has allowed us to take subcutaneous and oral amycretin in weight management to Phase III. We are excited about the amycretin molecule, and this marks an important step forward. We look forward to sharing more information on the design of the Phase III programme.”
In a Phase Ib/IIa study (NCT06064006), amycretin, a glucagon-like peptide-1 (GLP-1) and amylin receptor co-agonist, showed weight-loss outcomes of up to 22% in 36 weeks. This was higher than seen by the company’s blockbuster therapy Wegovy (semaglutide), which demonstrated a body weight change of 14% at week 36 in a Phase II study.
The Phase Ia/IIb study investigated three doses of once-weekly subcutaneous amycretin in 125 patients who are overweight or with obesity. The primary endpoint was treatment-emergent adverse events (TEAEs), with Novo Nordisk reporting that the most common events were gastrointestinal, and the majority were mild to moderate in severity.
If successful in a Phase III trial, GlobalData anticipates that amycretin will receive approval for adults with overweight or obesity in Q4 2030 in the US, followed by approval in the EU in Q1 2031.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataGlobalData is the parent company of Clinical Trials Arena.
Novo Nordisk moves to defend obesity market position
Novo Nordisk has signed a $812m partnership with Deep Apple Therapeutics to access novel compounds, not GLP-1RAs, for obesity and other diseases.
As well as this, the company has also listed two new studies for CagriSema, another candidate in its pipeline. The company recently announced underwhelming data from a Phase III trial, which, while meeting its primary endpoint, fell short of the 25% weight loss promise.
Following all these updates, Novo Nordisk’s share price has now increased, making it the most valuable company in Europe once again. It has a market cap of $359.28bn compared to German software company SAP at $359bn.
Novo Nordisk’s flagship semaglutide, marketed as Wegovy in weight loss and Ozempic in type 2 diabetes, is forecast to make $49bn in sales in 2030, according to GlobalData.
Its main competitor, Eli Lilly’s tirzepatide, marketed as Zepbound in weight loss and Mounjaro in type 2 diabetes, is projected to reach sales of $60.8bn. Lilly’s drug proved to have higher efficacy than Novo Nordisk’s in a head-to-head study between the pair.
