OBE07241_Novo_Obesity Core Story.lo1c

The obesity

core story

Novo Nordisk is committed to changing how the world sees

people with obesity to make obesity a heathcare priority,

and to developing a leading portfolio of treatment solutions.

PromoMatsID: XXXXXX

Approval date: XXX XXX

For internal use only – all content is subject to local legal review and any established approval procedures

1

Guidance

for use

What is the obesity core story?

The Novo Nordisk obesity core story is the cornerstone

of our obesity strategies, ensuring that Novo Nordisk

speaks with one voice about obesity.

The core story builds on the Novo Nordisk’s dual

mission to:

1. Change how the world sees people with obesity

and make obesity a healthcare priority;

2. Develop a leading portfolio of treatment solutions

The core story is based on scientific evidence that defines

obesity as a chronic, yet manageable disease, and illustrates

why obesity is a key commitment to Novo Nordisk. The

story is a living document and just as the story of obesity

continues to evolve, particularly in light of the COVID-19

pandemic, this core story will also be regularly updated.

Susie 2 For internal use only – all content is subject to local legal review and any established approval procedures 3

Our guiding principles for obesity disease awareness

Losing weight has a positive impact on health

Maintaining weight loss is difficult because regaining it is easy

Long-lasting medical treatment options are available

Lasting weight loss is possible

The chapters of the core story:

Abigale Sarah Wynford Susie

1 2 3 4

Obesity is a chronic

disease and it is not

going away:

We are acting on our

purpose by showing

leadership in solving

the global obesity

challenge

People with obesity

should not fight alone:

We will ensure that

healthcare systems

acknowledge and treat

obesity as a chronic

disease

The narrative around

obesity is changing:

We are partnering with

stakeholders to make

obesity a healthcare

priority

People with obesity

deserve care and

treatment:

Novo Nordisk offers

treatment solutions

and an industry-leading

obesity pipeline

Elroy 4 “Spoonface”

For internal use only – all content is subject to local legal review and any established approval procedures 5

1

Obesity is a chronic disease

and it is not going away

D’S

650 million adults

We are acting on our purpose by

showing leadership in solving the

global obesity challenge

125 million children

Worldwide, obesity impacts

650 million adults 1

124 million

children living with

obesity globally 2

Novo Nordisk is committed to tackling obesity and the complications

associated with it. In order to find solutons and address barriers to

obesity care, we advocate for a shift from individual to shared

societal responsibility.

975

MILLION OVER

THE NEXT

DECADE 1

The individual

The majority of people with obesity

believe weight management is their

own responsibility and that only lifestyle

interventions work. Yet, studies show

this approach is not enough to have a

lasting effect. 3

This has consequences, as obesity is

linked to a large number of complications

and disorders – some of which may impact

life-expectancy and health-related quality

of life. 4 However, with increasing weight

loss the improvements in complications

increase, and additional improvements

to overall health are seen with a weight

loss of 10% or more. 5-8

Society

The significant burden of obesity and

obesity-related conditions such as diabetes

and cardiovascular disease is welldocumented.

9 However, as the COVID-19

pandemic has highlighted, obesity not

only increases the likelihood of long-term

complications, it also puts individuals at

increased risk of acute complications and

severe outcomes from infectious diseases.

This has brought obesity into the public

agenda and further underscored the need

for obesity to be treated as an urgent

healthcare priority. 10-13

Annually, obesity accounts for USD 2 trillion

(DKK 12 trillion) in global healthcare costs. 14

Outside of healthcare, obesity is also costly

in the form of lost productivity including

sick days, reduced efficiency at work and

permanent disability. 15

6 For internal use only – all content is subject to local legal review and any established approval procedures 7

2

People with obesity should

not fight alone

We will ensure that healthcare systems

acknowledge and treat obesity as a

chronic disease

To tackle obesity, people with obesity should have access to appropriate

treatment and care.

Losing weight has a positive

impact on health

Why is obesity undertreated?

Reducing the stigma people with obesity face is critical:

On the street In the media At work Even at the doctor’s office

Stigma can impact their mental health and health-related quality of

life, 16-19 and it can stop them from seeking medical help.

There is a significant potential to educate about the physiological

causes of obesity, as well as the variety of treatment options available.

A strong-willed biology

Obesity is a multifactorial disease. 20

Psychological, social and

environmental factors contribute

to obesity. Genetics also play a

part with studies showing that up

to 70% of the causes of obesity

can be linked to genetics, family

history and ethnicity. 21-23

For more information on the science behind

obesity, see slides 17–21 of the Semaglutide 2.4

mg Simplified Core Science Deck.

What drives hunger?

Hormones like GLP-1, amylin,

ghrelin and peptide YY (PYY) play

an important role in regulating

appetite and the food we eat. 31,32

In the brain, they regulate

feelings of satiety or hunger and

so affect food intake. 31

People with obesity may

have different levels of these

hormones, which can impact

their hunger levels and desire

to eat. 33

The benefits of losing weight and keeping it

off can be substantial:

• 5% weight loss has significant health benefits,

including reducing the risk of type 2 diabetes. 24

• Further improvements are seen with weight loss

of 10–15% in cardiovascular disease and related

risk factors, 5 osteoarthritis, 6 and health-related

quality of life. 7,8

• An improvement in overall health can be achieved

with weight loss greater than 15%, including the

remission of type 2 diabetes, and a reduced risk

of cardiovascular mortality and certain types of

heart failure. 25-27

For more information on weight loss benefits, see slides 22–31

of the Semaglutide 2.4 mg Simplified Core Science Deck

Maintaining weight loss is difficult

because regaining it is easy

When weight loss is achieved, a process

called ‘metabolic adaptation’ kicks in. It

increases levels of hunger and the desire to

eat, while also reducing energy expenditure,

collectively driving weight regain. 28 This

process can persist for many years, which

goes some way to explain why two out of

three people are unable to maintain weight

Obesity remains underdiagnosed and

undertreated, with significant barriers

to weight management including

miscommunication, stigmatisation and lack

of a formal medical diagnosis. 3

For more information on the barriers to

weight management among people with

obesity and healthcare professionals, see

the Awareness, Care, & Treatment In

Obesity maNagemet – an International

Observation (ACTION IO) study. 3

8 loss in the long term. 28-30

9

3

The narrative around obesity

is changing

We are partnering with stakeholders to make

obesity a healthcare priority

The obesity narrative is changing

Progress is being made to address these issues in key areas

Media

The media has played a significant role in perpetuating weight

bias due to a combination of its overt negative sentiment,

inaccurate reporting, and the use of stigmatising photos and

language. This is gradually shifting to a more neutral and in some

cases even positive narrative.

Healthcare professionals:

There is increasing recognition amongst professional associations

and health organisations of the need to recognise obesity as a

chronic disease in order to treat and prevent it, and a focus on

how to address the growing prevalence of childhood obesity. 34-37

Policymakers:

Following major national efforts, many governments including

those of Portugal, Italy and Germany have now officially defined

obesity as a disease or disease process. 38-40

Look for long-lasting medical treatment options

Obesity is a manageable disease, and today’s options for tackling obesity are increasingly

growing. A holistic solution to treating obesity includes early diagnosis, lifestyle and

behavioural interventions, pharmacotherapy and bariatric surgery. 42,43

For more information on weight loss benefits, see slides 22–31 of the Semaglutide 2.4 mg Simplified Core Science Deck

How is Novo Nordisk helping?

Changing Obesity is our long-term commitment to improve the lives of people with

obesity and change how the world sees, prevents and treats obesity. As part of this,

we work to build healthier environments; foster empathy for people with obesity and

champion for obesity to become a healthcare priority; and ensure people living with

obesity have access to evidence-based care.

We have established and curate several platforms to educate about

obesity prevention and treatment:

Cities Changing

Diabetes

Obesity Clinics

Programme

Obesity Policy

Engagement Network

People with obesity:

Patient organisations, key influencers and obesity advocates are

contributing positively in the media and online by challenging

weight stigma and common perceptions of obesity. 41

Rethink Obesity ®

The Awareness, Care

and Treatment in Obesity

Management Study

Truth About Weight

For more information, please see the Changing Obesity portal.


4.1

People with obesity deserve

care and treatment

Novo Nordisk offers treatment solutions and an

industry-leading obesity pipeline

Lasting weight loss is possible

In Novo Nordisk, we are aiming to expand our ‘palette’ of treatment

options for people with obesity. We know that sustaining weight loss

can be challenging, so our aim is to bridge the gap in treating

obesity long-term.

Saxenda ® (liraglutide 3.0 mg)

Saxenda ® is currently the only GLP-1 RA approved for chronic weight

management in people living with obesity. 44

92% 3

1 IN 3

LOST 10%

BODY

WEIGHT

In adults treated with Saxenda ® , alongside lifestyle modification, 92%

achieved weight loss over one year and 1 out of 3 (33%) lost more than

10% of their body weight. 45 Furthermore, people treated with Saxenda ®

over three years were able to sustain their weight loss. 45,46

YEARS

Adolescents (aged 12–<18) living with

obesity who were treated with Saxenda ®

and underwent lifestyle therapy

demonstrated a significant reduction in

Body Mass Index (BMI) Standard Deviation

Score (BMI-SDS) and other weight-related

outcomes. 49 Saxenda ® is currently under

review with the regulatory authorities for

weight management in adolescents.

The long-term safety profile of Saxenda ® has

been well established by the SCALE clinical

trial programme in more than 5,000 patients

for up to three years and no new safety

signals were observed compared to the

profile of the wider GLP-1 RA class. 42

What is Saxenda ® ?

Saxenda ® is a once-daily GLP-1 analogue

with 97% similarity to naturally occurring

human GLP-1, the hormone that is released

in response to food intake. 42,50,51

Like natural GLP-1, Saxenda ® acts on specific

parts of the brain to reduce appetite and food

intake by increasing fullness and reducing

hunger, resulting in clinically relevant and

30, 37

maintained weight loss.

Saxenda ® is available in the US, Europe and

other countries. 42,52

For more information, see the Liraglutide

3.0 mg Core Science Deck.

Clinically relevant and maintained weight loss over three years had

additional health benefits including delayed time to onset of type

2 diabetes, 46 improvements in cardio-metabolic risk factors and

inflammatory biomarkers, 46,47 sleep apnoea, 48 and health-related

quality of life. 46


4.2


care and treatment



Semaglutide 2.4 mg

Semaglutide 2.4 mg is a new once-weekly GLP-1 analogue currently

under review with the regulatory authorities for chronic weight

management. If approved, semaglutide 2.4 mg has the potential to

transform obesity management. 53-56

Semaglutide provides significant and maintained weight loss in people

with obesity predominately through loss of fat and improved body

composition, 57 as shown in the STEP (Semaglutide Treatment Effect in

People with obesity) phase 3a clinical development programme. 58

15%

People with obesity treated with semaglutide 2.4 mg lost an average

of 15% in body weight sustained for more than one year, compared to

2.4% with placebo. 53

Continued treatment with semaglutide 2.4 mg supports people with

obesity to maintain weight loss and avoid weight regain. 54

Semaglutide has an established safety profile,

and the most commonly reported side effects

were gastrointestinal, as seen previously with

GLP-1 RAs. 53-56

In addition to weight loss, semaglutide

has been shown to provide consistent

improvements in cardio-metabolic risk

factors beyond weight loss, including

glycaemic parameters and lipid profile,

blood pressure and anti-inflammatory

biomarkers. 56,59-61 The SELECT trial is

designed to show if semaglutide 2.4 mg

may reduce risk of cardiovascular events in

people with overweight or obesity with prior

cardiovascular disease. 62

For more information, visit the Obesity

Communication semaglutide 2.4 mg

SharePoint page.

What is semaglutide?

Semaglutide is similar in structure (94%

homology) to the human GLP-1 hormone, 50,63

but it has been modified so that it is suitable

for once-weekly dosing. 64,65

Semaglutide induces weight loss by reducing

appetite and energy intake, improving control

of eating and reducing food cravings, and

lowering preference for fatty, energy-dense

foods .63,65-67

For more information, see the Semaglutide

2.4 mg Core Science Deck


4.3


care and treatment



As part of Novo Nordisk’s ambition to drive scientific progress and

understanding in obesity, we continue to invest in research and

development projects to identify and cultivate new and existing

obesity drug targets.

Hormones 101

Phase 2:

• AM833 – A long-acting amylin analogue intended as treatment for obesity

Phase 1:

• AM833-sema 2.4 mg – Combination of the amylin analogue and GLP-1

analogue semaglutide

• PYY 1875 – Novel analogue of appetite-regulating hormone PYY tested as single

and combination therapy with semaglutide

• LA-GDF15 – Long acting GDF15 analogue intended for appetite regulation

GLP-1:

GLP-1 stands for

glucagon-like peptide-1.

It is released in response

to food intake and helps

physiologically regulate

appetite. 50,63

GLP-1 medications can

be effective in weight

loss as they delay gastric

emptying, induce satiety,

and decrease food

intake. 50,63

Amylin:

Human amylin is a

pancreatic hormone

made and released

into the body alongside

insulin. 68-73

Human amylin is a

physiological regulator

of appetite. 68-73

It has the capacity to

induce weight loss

by reducing appetite

and delaying gastric

emptying. 68-70,74-76

PYY:

Human PYY is a

hormone produced

in the gut.

It helps regulate

appetite by slowing

gastric emptying. 31,32

GDF–15:

GDF-15 stands for

growth differentiation

factor–15.


How to use

the obesity

core story

Communication using the core story must be according to

local regulatory and legal guidelines.

Likewise, all external communication should be coordinated

with key internal stakeholders and made subject to local legal

review and any established approval procedures.

Please contact Jakob Jakobsen (JAJK) or Tove Iren

Spissøy Gerhardsen (TOIG) for questions or further guidance.

E: JAJK@novonordisk.com

M: +45 3079 0781

E: TOIG@novonordisk.com

M: +45 3077 7872

For more information, see the Core Obesity Deck.


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1

Obesity is a chronic disease

and it is not going away

D’S

650 million adults

We are acting on our purpose by

showing leadership in solving the global

obesity challenge

125 million children

Worldwide, obesity impacts

650 million adults 1

124 million

children living with

obesity globally 2

Novo Nordisk is committed to tackling obesity and the complications

associated with it. In order to find solutons and address barriers to

obesity care, we advocate for a shift from individual to shared

societal responsibility.

975

MILLION OVER

THE NEXT

DECADE 1

The individual

The majority of people with obesity

believe weight management is their

own responsibility and that only lifestyle

interventions work. Yet, studies show

this approach is not enough to have a

lasting effect. 3

This has consequences, as obesity is

linked to a large number of complications

and disorders – some of which may impact

life-expectancy and health-related quality

of life. 4 However, with increasing weight

loss the improvements in complications

increase, and additional improvements

to overall health are seen with a weight

loss of 10% or more. 5-8

Society

The significant burden of obesity and

obesity-related conditions such as diabetes

and cardiovascular disease is welldocumented.

9 However, as the COVID-19

pandemic has highlighted, obesity not

only increases the likelihood of long-term

complications, it also puts individuals at

increased risk of acute complications and

severe outcomes from infectious diseases.

This has brought obesity into the public

agenda and further underscored the need for

obesity to be treated as an urgent healthcare

priority. 10-13

Annually, obesity accounts for USD 2 trillion

(DKK 12 trillion) in global healthcare costs. 14

Outside of healthcare, obesity is also costly

in the form of lost productivity including

sick days, reduced efficiency at work and

permanent disability. 15


OBE07241_Novo_Obesity Core Story.lo1c

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