Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management - Seite 2

About the STEP clinical programme
STEP (Semaglutide Treatment Effect in People with obesity) is a phase 3 clinical development programme with once-weekly subcutaneous semaglutide 2.4 mg in obesity. The global phase 3a programme consists of four trials and has enrolled approximately 4,500 adults with overweight or obesity.

STEP 1 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in 1,961 adults with obesity or overweight. For more information, please read the company announcement here

STEP 2 – a 68-week safety and efficacy trial of subcutaneous  semaglutide 2.4 mg versus placebo and once-weekly subcutaneous semaglutide 1.0 mg in 1,210 adults with type 2 diabetes and either obesity or overweight. For more information, please read the company announcement here

STEP 3 – a 68-week safety and efficacy trial of subcutaneous  semaglutide 2.4 mg versus placebo in combination with intensive behavioural treatment in 611 adults with obesity or overweight. For more information, please read the company announcement here

STEP 4 – a 68-week safety and efficacy trial of subcutaneous  semaglutide 2.4 mg versus placebo in 803 adults with obesity or overweight who have reached the target dose of 2.4 mg after a 20-week run-in. For more information, please read the company announcement here

About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Further information

Media:
Mette Kruse Danielsen	[phone]	[e-mail]
Ken Inchausti (US)	[phone]	[e-mail]
Investors:
Daniel Muusmann Bohsen	[phone]	[e-mail]
Valdemar Borum Svarrer	[phone]	[e-mail]
Ann Søndermølle Rendbæk	[phone]	[e-mail]
Mark Joseph Root	[phone]	[e-mail]
Kristoffer Due Berg (US)	[phone]	[e-mail]

Company announcement No 74 / 2020