Novo links next-generation obesity drug to 22% weight loss at week 36

Novo Nordisk 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 pre-market trading .

The phase 1b/2a study compared the GLP-1 and amylin receptor agonist to placebo in 125 people who were overweight or obese. 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 the treatment.

Novo did not mention whether weight loss appeared to plateau after 36 weeks or whether 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 explored a range of ways to dial in effectiveness. The company’s shares fell a day after it released data on two of its potentially more effective options — Wegovy and high-dose Cagrisema — in recent weeks, but amycretin’s results fell nicely with investors. Shares of Novo climbed 11% to almost $90 in early trading.

The front-end data shared by Novo Friday lacks 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 trace the clinical development of amycretin in people who are overweight or obese but has not yet shared details. The company moved Cagrisema quickly into Phase 3, but Martin Holst Lange, MD, Ph.D., Novo’s executive vice president of development, was unsure whether the team would take the same approach with Amycretin when of a request for a conference call with analysts in August.

Work on the subcutaneous candidate is progressing in parallel with an oral amycretin program. Novo shared Phase 1 data on the oral candidate last year, reporting a 13.1% weight loss in people who took the therapy daily for 12 weeks.

Analysts at William Blair suggested that Novo could “leverage amycritin as an alternative to Lilly’s zepbound or retrrutide, although the exact strategic positioning will likely be clarified with full data (especially its tolerability).”

In a note this morning, analysts also called attention to three “significant caveats” of today’s announcement, including that no safety data was included and that Results were limited to patients who adhered to the treatment, which “has the potential to inflate treatment effect in the real-world setting.” »

Additionally, the increase in weight 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.