Wegovy maker Novo Nordisk is moving its investigational amycretin asset into late-stage weight loss trials starting early next year.
The Danish pharma and obesity heavyweight is moving forward with both subcutaneous and oral versions of amycretin, a GLP-1 and amylin receptor agonist.
It was previously unclear what Novo was planning for the dual-acting candidate. Now, the pharma has shared that the decision to move forward is based on feedback from regulatory authorities after end-of-phase 2 interactions for both forms of amycretin, according to a June 12 release.
A phase 3 program enrolling adults with overweight or obesity is slated to start in the first quarter of 2026.
In January, Novo recorded 22% weight loss in people who received weekly amycretin injections for 36 weeks in a phase 1b/2a study. The company didn’t mention whether weight loss appeared to plateau after 36 weeks or whether the trends suggest possible improvement over a longer period. In a study of Eli Lilly’s Zepbound, weight loss increased (PDF) from 20.9% after 36 weeks to 25.8% after 88 weeks.
The top-line data shared by Novo earlier this year didn’t include safety details, with the Danish pharma describing the safety profile as consistent with incretin therapies, adding that the most common adverse events were gastrointestinal.
As for the oral amycretin program, a phase 1 trial tied the candidate to 13.1% weight loss in people who took the therapy daily for 12 weeks.
Since Zepbound beat Wegovy in a head-to-head weight loss trial in December 2024, Novo has been searching for ways to dial up efficacy. In the same month, the company’s top next-gen contender, called CagriSema, failed to hit the expected weight loss mark of 25% in a phase 3 study.
After 68 weeks, people receiving CagriSema lost 22.7% of their body weight, data that sent Novo’s stock tumbling.
But Novo hasn’t been resting on its laurels, instead doubling down on bolstering its obesity pipeline via licensing deals. Over the last year and a half, the pharma has penned pacts with China’s United Laboratories, Lexicon Pharmaceuticals, Septerna and Deep Apple Therapeutics.