Novo Nordisk’s recent announcement of positive topline data from its Phase IIIa study STEP 4, investigating the use of semaglutide to treat obesity, will enable them to remain a leader in the obesity space, according to GlobalData, a leading data and analytics company.

In early May, Novo Nordisk announced positive topline data from its Phase IIIa study STEP 4, investigating the use of semaglutide in achieving sustained weight reduction for those suffering from obesity. The STEP 4 trial is a randomized, double-blind, multicenter, placebo-controlled, withdrawal trial that explores the use of semaglutide, subcutaneously administered, in comparison to a placebo. This is significant for the global obesity market, where Novo Nordisk’s Saxenda (liraglutide) currently occupies a 55% market share.

The STEP 4 trial lasted for a period of 68 weeks, with semaglutide 2.4mg administered to 902 people with obesity or overweight with comorbidities. The study reports that following an initial 20-week period, the 803 people who reached the target dose of semaglutide 2.4mg had a reduced mean body weight from 107.2kg to 96.1kg. Patients were then randomized to either continue treatment with once-weekly semaglutide 2.4mg or to receive a placebo for the remaining 48 weeks; those remaining on semaglutide for the entire trial period achieved a total weight loss of 17.4%.

Akash Patel Healthcare Analyst at GlobalData, commented: “The STEP 4 trial results demonstrate that semaglutide is highly efficacious in the treatment of obesity and has a safe and well-tolerated profile.”

The primary endpoint of the trial was achieved by demonstrating that, of all randomized patients, those who continued with semaglutide 2.4mg for 48 weeks, following the initial 20-week period, achieved an additional mean weight loss of 7.9% from a mean body weight at randomization of 96.1kg. Patients who remained compliant to semaglutide for 68 weeks, not taking any other anti-obesity therapies, achieved a mean weight loss of 18.2%.

Patel continues: “In addition to demonstrating high efficacy for weight loss, semaglutide was shown maintain sustained weight loss partially due to its efficacy but also due an increased rate of compliance from its once-weekly administration.”

Earlier this year, Ozempic (semaglutide) received a label update towards reducing major adverse cardiovascular event (MACE) risks in patients with type 2 diabetes (T2D) and known heart disease. The drug has a strong reputation in the T2D space, as expressed by key opinion leaders interviewed by GlobalData. Its growing name recognition, combined with positive experience physicians have described from prescribing the drug, will be a key driver for rapid uptake of semaglutide, if approved for obesity.

Patel adds: ‘‘Additionally, it’s also important to note that 57% of diagnosed T2D patients in the US suffer from obesity, which will likely lead physicians to increasingly favor prescribing semaglutide for treatment.”