Semaglutide 2.4 mg shows superior weight loss versus placebo in the phase 3 trials STEP 2 and STEP 3, thereby successfully completing the programme

Semaglutide 2.4 mg shows superior weight loss versus placebo in the phase 3 trials STEP 2 and STEP 3, thereby successfully completing the programme

Bagsværd, Denmark, 12 June 2020 – Novo Nordisk today announced headline results from the final two phase 3a clinical trials investigating once-weekly subcutaneous (sc) semaglutide 2.4 mg for weight management. STEP 2 in adults with obesity and type 2 diabetes (T2D) and STEP 3 as an adjunct to intensive behavioural therapy (IBT) in adults with obesity.

STEP 2 (obesity and type 2 diabetes)
STEP 2 is a 68-week randomised, double-blind, multicentre, placebo-controlled trial. The trial compared the efficacy and safety of once-weekly sc semaglutide 2.4 mg after 68 weeks to placebo and once-weekly sc semaglutide 1.0 mg. Treatment was provided in conjunction with lifestyle intervention, in 1,210 adults with T2D and either obesity or overweight with comorbidities.

The trial met both primary endpoints. In all people randomised¹, a statistically significant greater weight loss of 9.6% was achieved at 68 weeks with sc semaglutide 2.4 mg, from a mean baseline bodyweight of 99.8 kg, compared to placebo (3.4% weight loss) and sc semaglutide 1.0 mg (7.0% weight loss). 68.8% of those who received sc semaglutide 2.4 mg achieved a weight loss of 5% or more after 68 weeks, compared to 28.5% with placebo.

When evaluating the effects of treatment if taken as intended², people treated with sc semaglutide 2.4 mg achieved a weight loss of 10.6%, compared to a 3.1% weight loss with placebo and 7.5% weight loss with semaglutide 1.0 mg at 68 weeks. 73.2% of those who stayed on sc semaglutide 2.4 mg for 68 weeks achieved a weight loss of 5% or more, compared to 27.6% with placebo.

STEP 3 (adjunct to intensive behavioural therapy)
STEP 3 is a 68-week randomised, double-blind, multicentre, placebo-controlled trial. The trial investigated the effect of once-weekly sc semaglutide 2.4 mg after 68 weeks compared to placebo in 611 adults with obesity or overweight with comorbidities. Both treatments were in conjunction with IBT, defined as weekly behavioural support, dietician counselling and reduced calorie diet.

The trial met both of its primary endpoints. In all people randomised¹, a statistically significantly greater weight loss of 16.0% was achieved with sc semaglutide 2.4 mg as an adjunct to IBT, from a mean baseline bodyweight of 105.8 kg, compared to a 5.7% weight loss with placebo plus IBT after the 68‑week treatment period. 86.6% of those treated with sc semaglutide 2.4 mg achieved a weight loss of 5% or more after 68 weeks as an adjunct to IBT, compared to 47.6% with placebo plus IBT.