Latest news with #MartinLange
Yahoo
13-06-2025
- Business
- Yahoo
Novo Nordisk ramps up obesity fight, advances amycretin to Phase III
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. 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. GlobalData is the parent company of Clinical Trials Arena. 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. "Novo Nordisk ramps up obesity fight, advances amycretin to Phase III" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-06-2025
- Health
- Yahoo
Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development
Bagsværd, Denmark, 12 June 2025 – Novo Nordisk today announced that it will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies. The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management. 'We are very pleased that the feedback from regulatory authorities has allowed us to take subcutaneous and oral amycretin in weight management to phase 3,' said Martin Lange, executive vice president for Development at Novo Nordisk. '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 3 programme.' Novo Nordisk is now planning to initiate a phase 3 development programme with amycretin for adults with overweight or obesity during the first quarter of 2026. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and for adults with type 2 diabetes. Amycretin is developed for subcutaneous and oral administration. Oral Amycretin Phase 1 trial - The trial evaluated the single-ascending dose and multiple-ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 Amycretin Phase 1b/2a trial - The trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in people with overweight or obesity. The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks. About Novo NordiskNovo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ Company announcement No 17 / 2025 Attachment CA250612-amycretin-to-phase-3-clean
Yahoo
12-06-2025
- Health
- Yahoo
Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development
Bagsværd, Denmark, 12 June 2025 – Novo Nordisk today announced that it will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies. The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management. 'We are very pleased that the feedback from regulatory authorities has allowed us to take subcutaneous and oral amycretin in weight management to phase 3,' said Martin Lange, executive vice president for Development at Novo Nordisk. '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 3 programme.' Novo Nordisk is now planning to initiate a phase 3 development programme with amycretin for adults with overweight or obesity during the first quarter of 2026. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and for adults with type 2 diabetes. Amycretin is developed for subcutaneous and oral administration. Oral Amycretin Phase 1 trial - The trial evaluated the single-ascending dose and multiple-ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 Amycretin Phase 1b/2a trial - The trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in people with overweight or obesity. The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks. About Novo NordiskNovo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ Company announcement No 17 / 2025 Attachment CA250612-amycretin-to-phase-3-cleanSign in to access your portfolio
