Drugs

Novo Nordisk Obesity Drug Misses Endpoint

Novo Nordisk says its experimental obesity drug CagriSema delivered substantial weight loss in a head-to-head late-stage trial but failed to meet its primary objective of proving it was not inferior to Eli Lilly’s rival therapy tirzepatide (Zepbound and Mounjaro).

In the 84-week Phase 3 REDEFINE 4 study, patients treated with CagriSema — a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg — achieved average weight loss of 23.0% when assuming full adherence to therapy, according to the company. That compared with 25.5% for dual GIP/GLP-1 receptor agonist tirzepatide 15 mg. Under a treatment-regimen analysis — which includes treatment discontinuations — weight loss was 20.2% for CagriSema versus 23.6% for tirzepatide at week 84, it says. Because the difference exceeded the predefined statistical margin, the trial did not demonstrate non-inferiority, its primary endpoint.

Despite missing the non-inferiority goal, the magnitude of weight reduction with CagriSema remains among the highest reported for GLP-1–based therapies in obesity, Novo Nordisk notes. Company executives emphasized the 23% mean reduction as clinically meaningful and indicative of additive benefit from combining semaglutide — the active ingredient in Wegovy — with the amylin analog cagrilintide.

It says CagriSema appeared generally safe and well-tolerated in the study. The most common adverse events were gastrointestinal and were largely mild to moderate in severity, declining over time — a pattern consistent with the GLP-1 receptor agonist class.

Novo Nordisk submitted an NDA for CagriSema in December based on data from the pivotal REDEFINE 1 and REDEFINE 2 trials. An review action is expected before the end of the year,

Meanwhile, additional studies are underway to explore the drug’s full weight-loss potential. The Phase 3 REDEFINE 11 trial evaluating CagriSema 2.4 mg/2.4 mg is expected to report in the first half of 2027. The company also plans to initiate a higher-dose Phase 3 trial in the second half of 2026.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome