Oral semaglutide (Rybelsus®) is now the first and only oral GLP-1 RA approved for type 2 diabetes, with proven cardiovascular benefits1
This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus®) reduced cardiovascular death, heart attack and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk1
In addition, new results from SOUL will be presented at one of the largest diabetes conferences (EASD) later this week, showing that oral semaglutide significantly reduced hospitalisations compared with placebo2

Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial. SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsus® on cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD)1. Rybelsus® is now the first and only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) – mimicking a natural hormone in your body that helps regulate blood sugar, appetite, and digestion – available in the EU for type 2 diabetes with a proven cardiovascular benefit1.
“Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life – and this approval will help do just that,” said Emil Kongshøj Larsen, executive vice president, International Operations at Novo Nordisk. “This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.”
New results from the SOUL trial will be shared later this week at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting, 15–19 September. These include findings that treatment with oral semaglutide significantly reduced hospitalisations related to serious adverse events compared with placebo2. Additional SOUL results will be presented at the same
CVR no: 24 25 67 90
ate of approval: September
meeting, which highlight that the cardiovascular benefits of oral semaglutide were consistent regardless of body mass index (BMI) and body weight of participants3.
In the US, a decision is expected later this year for a label extension for the cardiovascular indication for Rybelsus®. Novo Nordisk has also submitted an application in the US for a oncedaily 25 mg oral formulation of semaglutide (Wegovy® in a pill) in adults living with obesity or overweight and cardiovascular disease. A decision is expected at the turn of this year, and if approved, Wegovy® would become the first oral GLP-1 RA indicated for chronic weight management.
Rybelsus® is the first and only oral GLP-1 RA approved for the treatment of type 2 diabetes, following its launch in 2019. It is supported by a strong clinical and real-world evidence base, demonstrating superior blood glucose reduction and body weight reduction versus multiple comparators, as well as an established safety profile in people with type 2 diabetes4-8.

            Results from a real-world survey suggest that semaglutide for weight management (Wegovy®) helped suppress food noise – unwanted and intrusive thoughts about food – in addition to its established effect on weight loss1

            The number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy®1 

            The majority of respondents reported improved mental health (64%) and healthier habits (80%) while taking Wegovy®1

 Novo Nordisk today announced results from the US-based INFORM survey of people taking semaglutide for weight management (Wegovy®), at the European Association for the Study of Diabetes (EASD) 2025, Vienna, Austria. The INFORM survey revealed that individuals experienced a substantial drop in food noise after starting Wegovy® treatment, alongside notable improvements in their mental well-being and lifestyle.1 Food noise – unwanted and intrusive thoughts about food – can affect the mental well-being, quality of life and weight loss efforts of those living with overweight or obesity.2

 “There are so many factors that challenge people with overweight or obesity in their efforts to lose weight, including food noise,” said Filip Knop, MD PhD, senior vice president and incoming chief medical officer at Novo Nordisk. “It is very encouraging to see these new data from people using Wegovy® that, in addition to weight loss, Wegovy® may help quiet disruptive thoughts about food, support improved mental well-being and help enable people to live healthier lives.”

On Wegovy® treatment, the survey showed a decline of 46% in the number of people experiencing constant thoughts about food throughout the day (reported by 62% before starting Wegovy® versus 16% on Wegovy®).1 The proportion of participants who reported that food noise had a negative effect on their lives was 60% before starting treatment, which dropped to 20% for respondents on Wegovy® treatment.1

September 2025

Around two-thirds (64%) of respondents reported that their mental health improved since starting Wegovy® treatment.1 Substantial majorities also reported developing a healthier lifestyle (76%) and healthier habits (80%).1 Around 8 in 10 (83%) of individuals in the study were satisfied with their Wegovy® treatment.1

Novo Nordisk continues to investigate how obesity impacts individuals’ day-to-day lives. An upcoming presentation at EASD highlights eating behaviour and control of eating with semaglutide from the STEP UP clinical trial. The findings add to the growing evidence of the broad health benefits of semaglutide in people with obesity, alongside its established effect on weight loss.3 Full results of the STEP UP and STEP UP T2D clinical trials were published in Lancet Diabetes Endocrinology on 14 September 2025.

نجح مستشفى الملك فيصل التخصصي ومركز الأبحاث بالرياض في خفض متوسط وقت انتظار المرضى للتنويم في قسم الطوارئ من أكثر من 13 ساعة في عام 2023 إلى 3.2 ساعة فقط بحلول منتصف عام 2025، محققًا انخفاضًا بنسبة 75٪، ليصبح ضمن أفضل 5٪ من المراكز الطبية الأكاديمية عالية السعة على مستوى العالم في مؤشر متوسط وقت انتظار التنويم في الطوارئ، بما يعكس قدرة التخصصي على إدارة ضغوط السعة التشغيلية، وتوسيع الوصول للرعاية الصحية التخصصية المتقدمة.

ولتحقيق هذا التحول، نفّذ “التخصصي” برنامجًا شاملًا لإعادة هندسة العمليات قائمًا على نهج مدعوم بالبيانات وتحليلات الأداء لمعالجة الأسباب الجذرية للتأخير في جميع مراحل رحلة المريض، بدءًا من دخوله إلى الطوارئ وحتى التنويم، بدعم من مركز القيادة والتحكم المعزز بالذكاء الاصطناعي، والذي يعمل على مدار الساعة لمتابعة حركة المرضى داخل المستشفى لحظة بلحظة، والتنبؤ بمناطق التكدس المحتملة قبل وقوعها.

ويتمثل الدور الرئيسي لإعادة هندسة العمليات في تصميم مسارات أكثر كفاءة استنادًا إلى بيانات ومؤشرات أداء دقيقة، مستنداً إلى بيانات مركز القيادة والتحكم التي ترصد تلقائياً أي تأخير في مسارات المرضى داخل المستشفى، يتبعها إرسال إشعار فوري إلى الموظف المختص لمعالجتها بشكل مباشر، وفي حال استمرار التأخير، تُصعّد الإشعارات تلقائيًا إلى المستوى الأعلى، مما يسرّع اتخاذ القرار ويعزز المحاسبة.

وضمن البرنامج الشامل لإعادة هندسة العمليات، استحدث المستشفى مسارات جديدة لتنويم الحالات المستقرة مباشرة من العيادات دون المرور بالطوارئ، إضافة إلى تسريع إجراءات الخروج في الصباح، وتعجيل صرف أدوية الخروج، وتسريع التشخيصات المخبرية والإشعاعية، ما أسهم في مضاعفة القدرة الاستيعابية، واستقبال المزيد من الحالات المعقدة مثل زراعة الأعضاء والعلاج بالخلايا المناعية، مما يعكس نجاح المستشفى في تحقيق التوازن بين تقديم رعاية صحية عالية المستوى، وتطبيق نظام تشغيل مرن وفعّال قادر على الاستجابة للطلب المتزايد.

وتزداد أهمية التحول بالنظر إلى حجم مستشفى الملك فيصل التخصصي ومركز الأبحاث بالرياض، الذي يعمل بطاقة سريرية تتجاوز 1500 سرير، ويخدم حالات عالية التعقيد تشمل زراعة الأعضاء والعلاج المناعي وزراعة النخاع، مما يجعل التحكم في حركة التنويم أحد أكثر التحديات حساسة وتأثيرًا على سلامة المرضى وكفاءة التشغيل. وفي هذا الإطار، يستعد “التخصصي” لمشاركة تجربته مع مؤسسات مرجعية عالمية، واستضافة زيارات تدريبية، وتطوير مبادرات تعاون في جودة الأداء وتخطيط السعة السريرية.