Novo Nordisk has reported 22% weight loss in people who received weekly amycretin injections for 36 weeks, triggering an 11% jump in the Danish drugmaker’s share price in premarket trading.
The phase 1b/2a study compared the GLP-1 and amylin receptor agonist to placebo in 125 people who are overweight or with obesity. Patients achieved an estimated weight loss of 9.7% on 1.25 mg after 20 weeks, 16.2% on 5 mg after 28 weeks and 22% on 20 mg after 36 weeks. The figures come from an analysis that assessed the effect of amycretin if all people adhered to treatment.
Novo made no mention of whether weight loss appeared to be plateauing after 36 weeks or whether the trends suggest further improvements are possible in longer trials. In a study of Eli Lilly’s Zepbound, weight loss increased (PDF) from 20.9% after 36 weeks to 25.8% after 88 weeks.
Zepbound beat Novo’s Wegovy in a head-to-head clinical trial in December, and Novo has been exploring a range of ways to dial up efficacy. The company’s stock fell in the aftermath of the publication of data on two of its potentially more efficacious options—high-dose Wegovy and CagriSema—in recent weeks, but the amycretin results went down well with investors. Novo’s stock climbed 11% to almost hit $90 in premarket trading.
The top-line data shared by Novo Friday lack important details, including anything beyond a high-level description of safety and tolerability. Novo said the safety profile was consistent with incretin therapies, adding that the most common adverse events were gastrointestinal and the vast majority were mild to moderate in severity.
Novo has seen enough to plot further clinical development of amycretin in people who are overweight or with obesity but is yet to share details. The company moved CagriSema rapidly into phase 3, but Martin Holst Lange, M.D., Ph.D., Novo’s executive vice president of development, was unsure whether the team would take the same approach with amycretin when asked on a conference call with analysts in August.
Work on the subcutaneous candidate is advancing in parallel to an oral amycretin program. Novo shared phase 1 data on the oral candidate last year, reporting 13.1% weight loss in people who took the therapy daily for 12 weeks.
William Blair analysts suggested that Novo could “leverage amycretin as an alternative to Lilly’s Zepbound or retatrutide, though the exact strategic positioning will likely be clarified with full data (in particular its tolerability).”
In a note this morning, the analysts also drew attention to three “important caveats” from today's announcement, including the fact that no safety data was included and that the results were limited to patients who adhered to treatment, which “has the potential to inflate treatment effect in the real-world setting.”
In addition, the weight increase seen in the placebo group was unusual, the analysts said, meaning that amycretin may appear to have performed relatively better than similar weight loss studies of other drugs.