Oral semaglutide 25 mg and 50 mg demonstrate superior reductions in HbA1c and body weight versus 14 mg in people with type 2 diabetes in the PIONEER PLUS phase 3 trial
Bagsværd, Denmark, 24 March 2023 - Novo Nordisk today announced headline results from the PIONEER PLUS trial, a phase 3b, 68-week, efficacy and safety trial with once-daily oral semaglutide 25 mg and 50 mg versus 14 mg as add-on to a stable dose of 1-3 oral antidiabetic medicines in people with type 2 diabetes in need of treatment intensification. The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in HbA1c at week 52 with both the 25 mg and 50 mg doses versus the 14 mg dose of oral semaglutide.
When evaluating the effects of treatment taken as intended1 and from a mean baseline HbA1c of 9.0 %, people treated with 25 mg and 50 mg oral semaglutide achieved a statistically significant higher HbA1c reduction of 1.9 percentage points and 2.2 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg.
From a mean baseline body weight of 96.4 kg, people treated with oral semaglutide 25 mg and 50 mg experienced a statistically significant higher weight loss of 7.0 kg and 9.2 kg, respectively, compared with a reduction of 4.5 kg with oral semaglutide 14 mg.
When applying the treatment policy estimand2, people treated with 25 mg and 50 mg oral semaglutide achieved a superior HbA1c reduction of 1.8 percentage points and 2.0 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg. People treated with oral semaglutide 25 mg and 50 mg experienced a superior weight loss of 6.7 kg and 8.0 kg, respectively, compared with a reduction of 4.4 kg with oral semaglutide 14 mg.
Trial product estimand Treatment policy
Oral semaglutide 14 mg 25 mg 50 mg 14 mg 25 mg 50 mg
HbA1c reduction (%-points) 1.5 1.9† 2.2† 1.5 1.8† 2.0†
Body weight reduction (kg) 4.5 7.0† 9.2† 4.4 6.7† 8.0†
†Statistically significant/superior vs oral semaglutide 14 mg
In the trial, all doses of oral semaglutide appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Gastrointestinal adverse events were most prominent during dose escalation and more frequent with oral semaglutide 25 mg and 50 mg than with oral semaglutide 14 mg.
"We are pleased to see the results from the PIONEER PLUS trial which add further evidence of the benefits of oral semaglutide for people living with type 2 diabetes," said Martin Holst Lange, executive vice president for Development at Novo Nordisk. "The higher efficacy from 25 mg and 50 mg doses provides the option to progress to higher doses if additional glycemic control or weight loss are needed".
Novo Nordisk expects to file for regulatory approvals in the US and the EU in 2023. The global roll-out of the 25 mg and 50 mg doses is contingent on portfolio prioritisations and manufacturing capacity.
About the PIONEER clinical programme
The PIONEER clinical development programme for oral semaglutide currently comprises nine phase 3 global clinical trials, including a cardiovascular outcomes trial, involving more than 10,000 adults with type 2 diabetes in total. Oral semaglutide 3 mg, 7 mg and 14 mg are approved under the brand name Rybelsus®, indicated for type 2 diabetes.
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 54,400 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 and YouTube.
Contact for further information
Media:
Ambre Brown Morley
+45 3079 9289
[email protected]
Natalia Salomao Abrahao (US)
+1 848 304 1027
[email protected]
Investors:
Daniel Muusmann Bohsen
+45 3075 2175
[email protected]
Jacob Martin Wiborg Rode
+45 3075 5956
[email protected]
David Heiberg Landsted
+45 3077 6915
[email protected]
Mark Joseph Root (US)
+1 848 213 3219
[email protected]
Bagsværd, Denmark, 24 March 2023 - Novo Nordisk today announced headline results from the PIONEER PLUS trial, a phase 3b, 68-week, efficacy and safety trial with once-daily oral semaglutide 25 mg and 50 mg versus 14 mg as add-on to a stable dose of 1-3 oral antidiabetic medicines in people with type 2 diabetes in need of treatment intensification. The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in HbA1c at week 52 with both the 25 mg and 50 mg doses versus the 14 mg dose of oral semaglutide.
When evaluating the effects of treatment taken as intended1 and from a mean baseline HbA1c of 9.0 %, people treated with 25 mg and 50 mg oral semaglutide achieved a statistically significant higher HbA1c reduction of 1.9 percentage points and 2.2 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg.
From a mean baseline body weight of 96.4 kg, people treated with oral semaglutide 25 mg and 50 mg experienced a statistically significant higher weight loss of 7.0 kg and 9.2 kg, respectively, compared with a reduction of 4.5 kg with oral semaglutide 14 mg.
When applying the treatment policy estimand2, people treated with 25 mg and 50 mg oral semaglutide achieved a superior HbA1c reduction of 1.8 percentage points and 2.0 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg. People treated with oral semaglutide 25 mg and 50 mg experienced a superior weight loss of 6.7 kg and 8.0 kg, respectively, compared with a reduction of 4.4 kg with oral semaglutide 14 mg.
Trial product estimand Treatment policy
Oral semaglutide 14 mg 25 mg 50 mg 14 mg 25 mg 50 mg
HbA1c reduction (%-points) 1.5 1.9† 2.2† 1.5 1.8† 2.0†
Body weight reduction (kg) 4.5 7.0† 9.2† 4.4 6.7† 8.0†
†Statistically significant/superior vs oral semaglutide 14 mg
In the trial, all doses of oral semaglutide appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Gastrointestinal adverse events were most prominent during dose escalation and more frequent with oral semaglutide 25 mg and 50 mg than with oral semaglutide 14 mg.
"We are pleased to see the results from the PIONEER PLUS trial which add further evidence of the benefits of oral semaglutide for people living with type 2 diabetes," said Martin Holst Lange, executive vice president for Development at Novo Nordisk. "The higher efficacy from 25 mg and 50 mg doses provides the option to progress to higher doses if additional glycemic control or weight loss are needed".
Novo Nordisk expects to file for regulatory approvals in the US and the EU in 2023. The global roll-out of the 25 mg and 50 mg doses is contingent on portfolio prioritisations and manufacturing capacity.
About the PIONEER clinical programme
The PIONEER clinical development programme for oral semaglutide currently comprises nine phase 3 global clinical trials, including a cardiovascular outcomes trial, involving more than 10,000 adults with type 2 diabetes in total. Oral semaglutide 3 mg, 7 mg and 14 mg are approved under the brand name Rybelsus®, indicated for type 2 diabetes.
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 54,400 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 and YouTube.
Contact for further information
Media:
Ambre Brown Morley
+45 3079 9289
[email protected]
Natalia Salomao Abrahao (US)
+1 848 304 1027
[email protected]
Investors:
Daniel Muusmann Bohsen
+45 3075 2175
[email protected]
Jacob Martin Wiborg Rode
+45 3075 5956
[email protected]
David Heiberg Landsted
+45 3077 6915
[email protected]
Mark Joseph Root (US)
+1 848 213 3219
[email protected]
25/3 2023 07:51 ProInvestorNEWS 3
111667 Novo når endemål i fase 3-studie om oral Semaglutid
24/3 17:02
Novo Nordisk har nået endemålene i fase 3b-studiet Pioneer Plus, hvor effektiviteten og sikkerheden ved vægttab gennem anvendelsen af oral Semaglutid i doserne 25 og 50 mg én gang dagligt er blevet testet.
Begge doser viste efter 52 uger højere effektivitet end ved anvendelsen af en dosis på 14 mg.
Det oplyser Novo Nordisk i en meddelelse fredag eftermiddag.
Studiet viste at deltagerne nåede et statistisk signifikant reduktion af langtidsblodsukker på henholdsvis 1,9 og 2,2 pct.point sammenlignet med en reduktion på 1,5 pct.point ved en dosis på 14 mg.
I forhold til en baseline-vægt på 96,4 kilo viste studiet et vægttab på 7 kilo og 9 kilo hos patienter, der blev behandlet med henholdsvis 25 og 50 mg mod 4,5 kilo hos patienter, der blev behandlet med en dosis på 14 mg.
Novo Nordisk venter at søge godkendelse hos myndighederne i USA og i EU i løbet af 2023.
Aktien i Novo Nordisk, der ellers blev handlet eksklusive retten til udbytte, steg efter nyheden 1,4 pct. til rekordkursen 1049 kr. fra et plus på 0,4 pct. forinden.
.\˙ MarketWire
24/3 17:02
Novo Nordisk har nået endemålene i fase 3b-studiet Pioneer Plus, hvor effektiviteten og sikkerheden ved vægttab gennem anvendelsen af oral Semaglutid i doserne 25 og 50 mg én gang dagligt er blevet testet.
Begge doser viste efter 52 uger højere effektivitet end ved anvendelsen af en dosis på 14 mg.
Det oplyser Novo Nordisk i en meddelelse fredag eftermiddag.
Studiet viste at deltagerne nåede et statistisk signifikant reduktion af langtidsblodsukker på henholdsvis 1,9 og 2,2 pct.point sammenlignet med en reduktion på 1,5 pct.point ved en dosis på 14 mg.
I forhold til en baseline-vægt på 96,4 kilo viste studiet et vægttab på 7 kilo og 9 kilo hos patienter, der blev behandlet med henholdsvis 25 og 50 mg mod 4,5 kilo hos patienter, der blev behandlet med en dosis på 14 mg.
Novo Nordisk venter at søge godkendelse hos myndighederne i USA og i EU i løbet af 2023.
Aktien i Novo Nordisk, der ellers blev handlet eksklusive retten til udbytte, steg efter nyheden 1,4 pct. til rekordkursen 1049 kr. fra et plus på 0,4 pct. forinden.
.\˙ MarketWire
