18.06.2024 14:00:50 - dpa-AFX: GNW-Adhoc: Novo Nordisk announces presentation of data from key semaglutide clinical trials in diabetes, obesity and chronic kidney disease at the 84th Scientific Sessions of the American Diabetes Association

* FLOW kidney outcomes trial data evaluating efficacy and safety of once-
    weekly semaglutide 1.0 mg in people with type 2 diabetes(1)
  * SELECT cardiovascular outcomes trial data evaluating efficacy and safety of
    once-weekly semaglutide 2.4 mg in people with obesity and established
    cardiovascular disease, without diabetes(2)
  * STEP HFpEF trial programme data evaluating efficacy and safety of once-
    weekly semaglutide 2.4 mg in people with obesity-related heart failure with
    preserved ejection fraction (HFpEF), with and without diabetes(3)(,4)

Bagsværd, Denmark, 18 June 2024 - Novo Nordisk today announced the presentation
of 34 abstracts highlighting the breadth of its portfolio at the upcoming
84(th) Scientific Sessions of the American Diabetes Association (ADA). The
conference will be held in-person and virtually from 21-24 June 2024 in Orlando,
US.
Additional data from three landmark trials with semaglutide will also be
presented in dedicated scientific sessions. The trials assess additional
potential benefits of semaglutide, including evaluation of kidney and
cardiovascular endpoints in people with type 2 diabetes and chronic kidney
disease (FLOW, semaglutide 1.0 mg) and cardiovascular and glucose-related
endpoints in people with obesity and CVD, with and without diabetes (SELECT and
STEP HFpEF, semaglutide 2.4 mg).
"We recognise that cardiometabolic conditions like cardiovascular disease,
chronic kidney disease, obesity and type 2 diabetes are often interlinked and
might occur in the same patient. We need to develop medicines that address
multiple facets of the diseases," said Stephen Gough, senior vice president and
global chief medical officer at Novo Nordisk. "The broad data being presented
this year at ADA reflect this goal. In particular, data from FLOW and SELECT
look at ways to treat common comorbidities of diabetes and obesity, such as
kidney disease and cardiovascular disease."
All abstracts will be published on the website of the journal Diabetes(®). Data
from the scientific sessions will be made available after their presentation.
Summary of presentations
Scientific sessions
The following data will be presented in the dedicated scientific sessions as a
part of the scientific agenda of the congress:
+------------------------------------------------------------------------------+
|The first dedicated kidney outcome trial with a GLP1-RA once-weekly | |semaglutide - FLOW trial results (scientific session; 24 June, 13:30-15:00 | |EST) | +------------------------------------------------------------------------------+
|SELECT trial - New looks at glycemia, inflammation, and heart | |failure (scientific session; 22 June, 08:00-09:00 EST) | +------------------------------------------------------------------------------+
|The STEP-HFpEF and STEP-HFpEF-DM trials - Targeting obesity to treat heart | |failure (scientific session; 23 June, 16:30-18:00 EST) | +------------------------------------------------------------------------------+
Poster and oral presentations
The following abstracts were submitted by Novo Nordisk and are accepted for
presentation at the congress:
+------------------------------------------------------------------------------+
|Diabetes | +------------------------------------------------------------------------------+
|Ozempic(®) (once-weekly semaglutide 1.0 mg) | +------------------------------------------------------------------------------+
| * Comparative effectiveness of semaglutide in T2D - year 2 results of a | | randomized pragmatic clinical trial (230-OR) | +------------------------------------------------------------------------------+
| * Long-term effectiveness associated with maintenance doses of once-weekly | | semaglutide in US adults with poorly controlled T2D (766-P) | +------------------------------------------------------------------------------+
| * Semaglutide in patients with peripheral arterial disease and type 2 | | diabetes: comorbidities and concomitant medications from the STRIDE trial | | (784-P) | +------------------------------------------------------------------------------+
| * Real-world impact of once-weekly injectable semaglutide on weight, BMI and| | HbA(1c )outcomes in type?2 diabetes: an observational study (PAUSE) (857- | | P) | +------------------------------------------------------------------------------+
| * Real-World Impact of Once-Weekly Injectable Semaglutide (sema OW) vs. | | Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i) on HbA1c, Weight, and | | Health Care Resource Utilization (HCRU) Outcomes in Type 2 Diabetes (T2D) | | - An Observational Study (PAUSE) (1884-LB) | +------------------------------------------------------------------------------+
|Rybelsus(®) (once-daily oral semaglutide) | +------------------------------------------------------------------------------+
| * Evaluating the efficacy of oral semaglutide in Chinese patients with T2D | | by baseline characteristics: post hoc analysis of PIONEER 11 and 12 (752- | | P) | +------------------------------------------------------------------------------+
| * Real-world impact of fasting on adherence to dosing instructions and | | efficacy of oral semaglutide during Ramadan in people with type 2 | | diabetes: O-SEMA-Fast sub-analysis (808-P) | +------------------------------------------------------------------------------+
|CagriSema | +------------------------------------------------------------------------------+
| * CagriSema improves insulin sensitivity in diet-induced obese rats (763-P) | +------------------------------------------------------------------------------+
|Once-weekly insulin icodec | +------------------------------------------------------------------------------+
| * Healthcare resource utilization and costs with timely vs delayed basal | | insulin initiation (816-P) | +------------------------------------------------------------------------------+
| * Demographic, clinical, and treatment characteristics of patients with | | timely vs. delayed basal insulin initiation (817-P) | +------------------------------------------------------------------------------+
| * No evidence of increased physical activity-related hypoglycemia with once-| | weekly insulin icodec versus once-daily basal insulin in T1D: ONWARDS 6 | | (824-P) | +------------------------------------------------------------------------------+
| * Efficacy and safety of once-weekly insulin icodec versus once-daily basal | | insulin in individuals with T2D by kidney function: ONWARDS 1-5 (826-P) | +------------------------------------------------------------------------------+
| * No evidence of increased physical activity-related hypoglycemia with once-| | weekly insulin icodec versus once-daily basal insulin in T2D: ONWARDS 1-5 | | (830-P) | +------------------------------------------------------------------------------+
| * Adherence to app-based dose guidance for once-weekly insulin icodec in | | insulin-naive T2D: post hoc analysis of ONWARDS 5 (836-P) | +------------------------------------------------------------------------------+
| * Impact of age on the efficacy and safety of once-weekly insulin icodec | | versus once-daily insulin in T2D (ONWARDS 1-5) (838-P) | +------------------------------------------------------------------------------+
| * Efficacy and safety of once-weekly insulin icodec versus once-daily basal | | insulin in type 2 diabetes according to baseline glucagon-like peptide-1 | | receptor agonist use: ONWARDS 1-5 (840-P) | +------------------------------------------------------------------------------+
| * Efficacy and safety of once-weekly insulin icodec vs once-daily basal | | insulin in T2D by ethnicity and race: ONWARDS 1-5 (841-P) | +------------------------------------------------------------------------------+
| * Cost-effectiveness of insulin icodec for the treatment of type 2 diabetes | | in Canada (1046-P) | +------------------------------------------------------------------------------+
| * Efficacy and safety outcomes with once-weekly insulin icodec versus once- | | daily insulin degludec in T1D according to glycemic variability: ONWARDS | | 6 post hoc analysis (1882-LB) | +------------------------------------------------------------------------------+
|Daily insulins | +------------------------------------------------------------------------------+
| * Influence of the functionally selective insulin analog NNC-965 on cardiac | | structure and function versus insulin glargine (IGla) (822-P) | +------------------------------------------------------------------------------+
| * Improved glycemic control in people with type?2 diabetes (T2D) initiating | | or switching to insulin degludec/insulin aspart (IDegAsp) in a real-world | | setting in China (publication only) | +------------------------------------------------------------------------------+
|General diabetes | +------------------------------------------------------------------------------+
| * Persistence and adherence of once weekly GLP-1 receptor agonists in | | patients with type 2 diabetes and atherosclerotic cardiovascular disease | | in a real-world setting (740-P) | +------------------------------------------------------------------------------+
| * Impact of newer GLP-1 RAs on HbA1c in US adults with type 2 diabetes: a | | population-level time-series analysis (774-P) | +------------------------------------------------------------------------------+
| * Understanding attitudes about basal insulin: insights from a global survey| | of people with type 2 diabetes (833-P) | +------------------------------------------------------------------------------+
| * The value of the guideline-recommended management of type 2 diabetes: A | | novel population-level system dynamics approach (1040-P) | +------------------------------------------------------------------------------+
| * Prevalence of atherosclerotic cardiovascular diseases in adults with type | | 2 diabetes in Jordan: the PACT-MEA Study (1789-LB) | +------------------------------------------------------------------------------+
| * In vivo chain-splitting of human insulin (2032-LB) | +------------------------------------------------------------------------------+
|Digital Health | +------------------------------------------------------------------------------+
| * Improvement in time in range after smart insulin pen initiation in | | Austria (842-P) | +------------------------------------------------------------------------------+
| * Multinational analysis of factors associated with missed bolus insulin | | injections using smart pen data (843-P) | +------------------------------------------------------------------------------+
|Obesity | +------------------------------------------------------------------------------+
|Wegovy(®) (once-weekly semaglutide 2.4 mg) | +------------------------------------------------------------------------------+
| * CONCRETE - characterization of patients receiving telemedicine and branded| | antiobesity medication for medical weight management: a retrospective | | analysis (1684-P) | +------------------------------------------------------------------------------+
| * Clinical outcomes in patients with obesity or overweight treated with | | semaglutide 2.4 mg: a real-world retrospective cohort study in the United | | States (SCOPE 2) (1691-P) | +------------------------------------------------------------------------------+
| * Modeling the Impact of Semaglutide 2.4 mg in U.S. Patients with | | Atherosclerotic Cardiovascular Disease and BMI >=27 kg/m2 (1981-LB) | +------------------------------------------------------------------------------+
|General obesity | +------------------------------------------------------------------------------+
| * Patient-centered weight management clinical decision support: a proof-of- | | concept study (1101-P) | +------------------------------------------------------------------------------+
| * Prevalence, characteristics, and clinical burden among patients with | | overweight or obesity and established ASCVD in a US real world | | setting (1692-P) | +------------------------------------------------------------------------------+
About Ozempic(® )
Once-weekly subcutaneous semaglutide is approved in 0.5 mg, 1.0 mg and 2.0 mg
doses under the brand name Ozempic(®) and indicated as an adjunct to diet and
exercise to improve glycaemic control in adults with type 2 diabetes and to
reduce the risk of major adverse cardiovascular events (cardiovascular death,
non-fatal myocardial infarction or non-fatal stroke) in adults with type 2
diabetes and established cardiovascular disease.
About Rybelsus(®)
Oral semaglutide is administered once daily and is approved for use in three
therapeutic doses, 3 mg, 7 mg and 14 mg under the brand name Rybelsus(®). It is
indicated for the treatment of adults with insufficiently controlled type 2
diabetes mellitus to improve glycaemic control as an adjunct to diet and
exercise.
About Wegovy(®)
Once-weekly subcutaneous semaglutide 2.4 mg is approved under the brand name
Wegovy(®) and is indicated in combination with a reduced calorie diet and
increased physical activity to reduce the risk of major adverse cardiovascular
events (cardiovascular death, non-fatal myocardial infarction, or non-fatal
stroke) in adults with established cardiovascular disease and either obesity or
overweight, as well as to reduce excess body weight and maintain weight
reduction long term in adults and paediatric patients aged 12 years and older
with obesity and in adults with overweight in the presence of at least one
weight-related comorbid condition.
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 serious
chronic diseases, built upon our heritage in diabetes. We do so by pioneering
scientific breakthroughs, expanding access to our medicines, and working to
prevent and ultimately cure disease. Novo Nordisk employs about 66,000 people in
80 countries and markets its products in around 170 countries. For more
information, visit novonordisk.com (http://www.novonordisk.com), Facebook
(http://www.facebook.com/novonordisk), Instagram
(https://www.instagram.com/novonordisk), X (http://www.twitter.com/novonordisk),
LinkedIn (http://www.linkedin.com/company/novo-nordisk) and YouTube
(http://www.Youtube.com/novonordisk).
Contacts for further information
Media:
 Ambre James-Brown                      Liz Skrbkova (US)
 +45 3079 9289                          +1 609 917 0632
 abmo@novonordisk.com                   lzsk@novonordisk.com
 (mailto:abmo@novonordisk.com)          (mailto:lzsk@novonordisk.com)

Investors:
 Jacob Martin Wiborg Rode               David Heiberg Landsted
 +45 3075 5956                          +45 3077 6915
 jrde@novonordisk.com                   dhel@novonordisk.com
 (mailto:jrde@novonordisk.com)          (mailto:dhel@novonordisk.com)
 Sina Meyer                             Frederik Taylor Pitter
 +45 3079 6656                          +45 3075 8259
 azey@novonordisk.com                   fptr@novonordisk.com
 (mailto:azey@novonordisk.com)          (mailto:fptr@novonordisk.com)
 Ida Melvold Gjøsund                    Mark Joseph Root (US)
 +45 3077 5649 idmg@novonordisk.com     +1 848 213 3219
 (mailto:idmg@novonordisk.com)          mjhr@novonordisk.com
                                        (mailto:mjhr@novonordisk.com)

_______________________
References
1. ClinicalTrials.gov. A Research Study to See How Semaglutide Works Compared
to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW).
Available at: https://clinicaltrials.gov/study/NCT03819153. Last accessed: June
2024.
2. ClinicalTrials.gov. Semaglutide Effects on Heart Disease and Stroke in
Patients With Overweight or Obesity (SELECT). Available
athttps://clinicaltrials.gov/study/NCT03574597. Last accessed: June 2024.
3. ClinicalTrials.gov. Research Study to Investigate How Well Semaglutide
Works in People Living With Heart Failure and Obesity (STEP-HFpEF). Available
at: https://clinicaltrials.gov/study/NCT04788511. Last accessed: June 2024.
4. ClinicalTrials.gov. Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes (STEP HFpEF DM).
Available at: https://clinicaltrials.gov/study/ NCT04916470. Last accessed: June
2024.
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Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
NOVO-NORDISK AS B DK 0,1 A3EU6F Xetra 134,500 26.06.24 17:35:44 -3,600 -2,61% 0,000 0,000 137,100 138,100

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