Semaglutide 2.4 mg demonstrates superior and sustained weight loss versus placebo and in addition a 17.4% weight loss after 68 weeks in STEP 4 trial

Bagsværd, Denmark, 13 May 2020 – Novo Nordisk today announced headline results from STEP 4, the first completed phase 3a trial in the STEP programme. STEP 4 is a randomised, double-blind, multicentre, placebo-controlled, withdrawal trial exploring sustained weight management with semaglutide vs placebo. The 68-week trial investigated the effect of once-weekly subcutaneous (sc) semaglutide 2.4 mg on body weight in 902 people with obesity or overweight with comorbidities. After the 20-week run-in period, the 803 people reaching the target dose of semaglutide 2.4 mg had reduced their mean body weight from 107.2 kg to 96.1 kg and were randomised to continued treatment with either once-weekly sc semaglutide 2.4 mg or placebo for 48 weeks.

The trial achieved its primary objective by demonstrating that in all people randomised¹, continued treatment with sc semaglutide 2.4 mg for 48 weeks (after the run-in period) resulted in an additional mean weight loss of 7.9%, from a mean baseline body weight at randomisation of 96.1 kg, whereas people on placebo regained 6.9% of the body weight. The treatment difference was statistically significant. People who received sc semaglutide 2.4 mg for 68 weeks (run-in period plus 48 weeks) achieved a total weight loss of 17.4%.

When evaluating the effects of treatment if taken as intended², people who continued treatment with sc semaglutide 2.4 mg achieved an additional mean weight loss of 8.8% whereas people on placebo regained 6.5%. The treatment difference was statistically significant. People who stayed on sc semaglutide 2.4 mg for 68 weeks achieved a weight loss of 18.2%.

In the trial, sc semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common adverse events among people treated with sc semaglutide 2.4 mg were gastrointestinal events. As seen previously with GLP-1 receptor agonists, most events were transient and mild or moderate in severity.

“Achieving sustained weight loss without medical therapy is known to be very challenging. STEP 4 shows that people continuing treatment with semaglutide achieved a further substantial weight loss while people switching to placebo, on the other hand, regained a significant amount of weight,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk and continues, “this highlights that obesity is a chronic disease requiring sustained treatment, and we look forward to sharing additional results from the ongoing STEP programme”.