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Novo Nordisk’s first semaglutide obesity trial hits the mark

Drug achieved statistically significant improvement in weight loss

Novo Nordisk HQ

Novo Nordisk has taken a big step towards its ambitious growth targets in obesity after reporting positive results with its once-weekly GLP-1 agonist semaglutide in a phase 3 trial.

The Danish drugmaker has been eagerly anticipating the results of the STEP 4 study, the first of five intended to secure approval for the drug as a drug treatment for people with obesity or who are overweight.

Novo Nordisk’s obesity franchise – currently represented by Saxenda (liraglutide) – grew 30% in the first quarter to DKK 1.58bn ($228m), as the drug continued its roll-out and reached 46 world markets.

The company has said it intends to double the size of its obesity franchise by 2025, and a big part of this will be a filing of semaglutide for obesity – due later this year.

The once-weekly injectable version of the drug is already approved at a lower dose under the Ozempic brand, and in an oral formulation as Rybelsus, for type 2 diabetes, and is Novo Nordisk’s fastest-growing drug.

In the 800-patient STEP 4 study, semaglutide given by subcutaneous injection once a week results in a weight loss of around 11 kg among the participants on average, down from 107.2 kg to 96.1 kg, over the course of a 20-week run in period in which the drug was slowly escalated to a target dose of 2.4 mg.

For another 48 weeks the patients took weekly 2.4mg doses or placebo. At the end of the period those on the GLP-1 agonist lost another 7.9% of their body weight on average, while those in the control group regained 6.9%.

The primary endpoint in the study compared semaglutide to placebo in all patents, regardless of whether they adhered to treatment or used other obesity therapies. On this measure, Novo Nordisk’s drug achieved an 8.8% loss in weight, whereas people on placebo regained 6.5%, which was a statistically significant improvement.

Novo Nordisk’s chief science officer Mads Krogsgaard Thomsen said on Novo Nordisk’s first-quarter results call that STEP 4’s design “mimics what happens in the real world that people treat themselves for five months, then they stop and put on weight again – the situation of chronic therapy versus abrupt therapy”.

All told, those who stayed on semaglutide across the whole 68-week period lost 18.2% of their weight – almost a fifth of their starting weight – which would be expected to have material health benefits.

“Achieving sustained weight loss without medical therapy is known to be very challenging,” said Thomsen, adding: “This highlights that obesity is a chronic disease requiring sustained treatment.”

After STEP 4, Novo Nordisk is awaiting the results of the STEP 1 obesity trial, which will compare semaglutide 2.4mg to placebo across 68 weeks – with no run-in phase – and includes more than 1,600 patients.

In the first half of the year the company should also have read-outs from the 1,200-patient STEP 2 trial in subjects with both diabetes and obesity or who are overweight, and the STEP 3 study – looking at the GLP-1 agonist used alongside intensive behavioural therapy – in more than 600 patients.

The positive data in obesity follows hard on the heels of a positive mid-stage trial of semaglutide in non-alcoholic steatohepatitis (NASH), which could add another potentially lucrative indication for the drug if that is repeated in phase 3 testing.

Article by
Phil Taylor

14th May 2020

From: Research



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