Wegovy and Ozempic Maker Novo Nordisk Shares Data From Phase 3 Diabetes Study Of Semaglutide/Insulin Containing Candidate

Novo Nordisk A/S NVO announced topline results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. 

Semaglutide is used in Novo Nordisk's blockbuster weight loss and diabetes drugs Wegvoy and Ozempic.

COMBINE 3 was a 52-week, open-label treat-to-target trial comparing the efficacy and safety of once-weekly IcoSema vs once-daily insulin glargine U100 and insulin aspart (injected 2-4 times a day during mealtimes), dosed with or without oral glucose-lowering medications, in 679 people with type 2 diabetes inadequately controlled on daily basal insulin. 

The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart. 

From an overall baseline HbA1c of 8.30%, once-weekly IcoSema achieved an estimated reduction in HbA1c of -1.47 percentage points compared with -1.40 percentage points for insulin glargine U100 and insulin aspart.

Further, from a baseline body weight of 85.8 kg, people treated with IcoSema achieved a superior reduction in estimated change of body weight, a weight loss of -3.6 kg with IcoSema, and a weight gain of 3.2 kg with insulin glargine U100 and insulin aspart (estimated treatment difference: -6.7 kg). 

In the trial, IcoSema was superior to insulin glargine U100 and insulin aspart in estimated rates of severe or clinically significant (blood glucose below 3.0 mmol/L) hypoglycemia, with 0.26 events per patient-year of exposure for once-weekly IcoSema and 2.18 events per patient-year of exposure for insulin glargine U100 and insulin aspart. 

In the trial, once-weekly IcoSema appeared to have a safe and well-tolerated profile. 

The most common adverse events for people treated with IcoSema were gastrointestinal, consistent with GLP-1 receptor agonist class, and the vast majority were mild to moderate.

Price Action: NVO shares are down 0.05% at $105.90 on the last check Monday.

Photo via Company