Novo’s CagriSema tops Eli Lilly’s tirzepatide in new trial

Novo ↗ 0.02% unveiled new clinical data on Monday showing its experimental obesity drug CagriSema delivered superior weight loss compared to a lower dose of Eli Lilly's ↘ 0.79% tirzepatide, offering a rebound for the company after its next-generation treatment stumbled in a head-to-head trial earlier this year.

The results, released at Novo's Capital Markets Day in London on September 21, showed CagriSema at a 1.0 mg/1.0 mg dose achieved 12.4% weight loss versus 9.1% for tirzepatide at 5 mg after 60 weeks in adults with type 2 diabetes in the REIMAGINE 5 trial. In a separate trial, REDEFINE 9, the same CagriSema dose produced 21% weight loss versus 2% for placebo after 68 weeks in adults with overweight or obesity.stocktitan

A Comeback After February's Setback

The data arrive at a critical moment for Novo. In February, CagriSema failed to match tirzepatide in the REDEFINE 4 trial, where its highest dose of 2.4 mg/2.4 mg produced 23% weight loss compared to 25.5% for tirzepatide at 15 mg, missing the primary endpoint of non-inferiority. Novo's shares tumbled on those results, and the company has spent much of 2026 trying to rebuild investor confidence in its obesity pipeline.sec+2

The new trials tested CagriSema at a lower dose against a lower dose of tirzepatide, a comparison Novo framed around the reality that not all patients receive or tolerate the highest available doses of current therapies. "These findings strengthen our confidence in its potential, add to the growing evidence for amylin biology and reinforce our ambition to advance the next generation of treatments for obesity and type 2 diabetes," said Martin Holst Lange, Novo's executive vice president for research and development.stocktitan

FDA Decision and Launch Timeline

Novo filed a New Drug Application with the FDA in December 2025 for CagriSema in weight management, with a regulatory decision expected in the fourth quarter of 2026. If approved, a U.S. launch could follow in early 2027.cnbc+2

The company has positioned CagriSema — a once-weekly injection combining the GLP-1 receptor agonist semaglutide with the amylin analog cagrilintide — as its next major product in the obesity market. The Capital Markets Day presentation also included promising early data on painful diabetic neuropathy and outlined Novo's broader pipeline strategy as it faces intensifying competition from Eli Lilly in the fast-growing weight-loss drug market.stocktitan+1