Bagsværd, Denmark, Four June 2020 – Novo Nordisk at present introduced headline outcomes from STEP 1, a section 3a trial within the STEP programme. STEP 1 is a 68-week randomised, double-blind, multicentre, placebo-controlled weight administration trial. The trial investigated the efficacy and security of once-weekly subcutaneous (sc) semaglutide 2.Four mg on physique weight over 68 weeks in comparison with placebo in 1,961 adults with weight problems or obese with comorbidities, each at the side of way of life intervention.
The STEP 1 trial met each main endpoints. In all individuals randomised1, a statistically vital and superior discount in physique weight was achieved with sc semaglutide 2.Four mg in comparison with placebo after 68 weeks. Folks handled with sc semaglutide 2.Four mg achieved a weight lack of 14.9%, from a imply baseline physique weight of 105.Three kg, in comparison with a 2.4% weight reduction with placebo. As well as, 86.4% of those that acquired sc semaglutide 2.Four mg reached a weight lack of 5% or extra after 68 weeks, in comparison with 31.5% with placebo.
When evaluating the consequences of therapy taken as meant2, individuals handled with sc semaglutide 2.Four mg achieved a weight lack of 16.9%, in comparison with a 2.4% weight reduction with placebo after 68 weeks and 92.4% achieved a weight lack of 5% or extra, in comparison with 33.1% with placebo. The therapy variations have been statistically vital.
Within the trial, sc semaglutide 2.Four mg appeared to have a protected and well-tolerated profile, as seen with earlier trials. The most typical adversarial occasions amongst individuals handled with sc semaglutide 2.Four mg have been gastrointestinal occasions. Most occasions have been transient, and delicate or reasonable in severity.
“The outcomes from the pivotal STEP 1 trial present that semaglutide 2.Four mg supplies unprecedented weight reduction after 68 weeks. Additional, virtually all sufferers achieved a weight lack of a minimum of 5%, which is broadly recognised as clinically related. The outcomes from this trial are very encouraging, boding properly for the therapy outlook for individuals with weight problems“ says Mads Krogsgaard Thomsen, government vice chairman and chief science officer of Novo Nordisk. “We now look ahead to quickly sharing further knowledge from the remaining two STEP medical trials.”
About weight problems and sc semaglutide 2.Four mg for weight administration
Weight problems is a persistent illness that requires long-term administration. It’s related to many critical well being penalties and decreased life expectancy. Weight problems-related problems are quite a few and embrace sort 2 diabetes, coronary heart illness, obstructive sleep apnoea, persistent kidney illness, non-alcoholic fatty liver illness and most cancers.
As soon as-weekly sc semaglutide 2.Four mg is being investigated by Novo Nordisk as a therapy for adults with weight problems. Semaglutide is an analogue of the human glucagon‑like peptide-1 (GLP-1) hormone. It induces weight reduction by decreasing starvation, growing emotions of fullness and thereby serving to individuals eat much less and cut back their calorie consumption.
In regards to the STEP medical programme
STEP (Semaglutide Therapy Impact in Folks with weight problems) is a section Three medical growth programme with once-weekly sc semaglutide 2.Four mg in weight problems. The worldwide medical section 3a programme consists of 4 trials, having enrolled roughly 4,500 adults with obese or weight problems.
STEP 1 – a 68-week security and efficacy trial of sc semaglutide 2.Four mg versus placebo in 1,961 adults with weight problems or obese.
STEP 2 – a 68-week security and efficacy trial of sc semaglutide 2.Four mg versus placebo and once-weekly sc semaglutide 1.zero mg once-weekly in 1,210 adults with sort 2 diabetes and both weight problems or obese.
STEP 3 – a 68-week security and efficacy trial of sc semaglutide 2.Four mg versus placebo together with intensive behavioural therapy in 611 adults with weight problems or obese.
STEP 4 – a 68-week security and efficacy trial of sc semaglutide 2.Four mg versus placebo in 803 adults with weight problems or obese who reached the goal dose of two.Four mg after a 20-week run-in. The outcomes have been reported on 13 Might 2020.
About Novo Nordisk
Novo Nordisk is a number one international healthcare firm, based in 1923 and headquartered in Denmark. Our function is to drive change to defeat diabetes and different critical persistent illnesses resembling weight problems and uncommon blood and endocrine problems. We accomplish that by pioneering scientific breakthroughs, increasing entry to our medicines and dealing to forestall and in the end remedy illness. Novo Nordisk employs about 43,100 individuals in 80 international locations and markets its merchandise in round 170 international locations. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Inventory Change (NVO). For extra data, go to novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
Firm announcement No 37 / 2020
1 Primarily based on the therapy coverage estimand (main statistical strategy): therapy impact no matter therapy adherence or initiation of different anti-obesity therapies
2 Primarily based on the trial product estimand (secondary statistical strategy): therapy impact if all individuals adhered to therapy and didn’t provoke different anti-obesity therapies