Clinical Trials Register

Summary
EudraCT Number:	2017-003380-35
Sponsor's Protocol Code Number:	EX9536-4388
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-003380-35

A.3

Full title of the trial

SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity

SELECT – Effetti di semaglutide sugli esiti cardiovascolari in persone obese o in sovrappeso

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

SELECT - Semaglutide effects on heart disease and stroke in patients with overweight or obesity

SELECT – Effetti di semaglutide sugli esiti cardiovascolari in persone obese o in sovrappeso

A.3.2

Name or abbreviated title of the trial where available

SELECT

A.4.1

Sponsor's protocol code number

EX9536-4388

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1200-5564

A.5.4

Other Identifiers

Name:

SELECT

Number:

EX9536-4388

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	NOVO NORDISK. S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novo Nordisk A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novo Nordisk A/S
B.5.2	Functional name of contact point	Clinical Disclosure (1452)
B.5.3	Address:
B.5.3.1	Street Address	Novo Allé
B.5.3.2	Town/ city	Bagsværd
B.5.3.3	Post code	2880
B.5.3.4	Country	Denmark
B.5.6	E-mail	clinicaltrials@novonordisk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Semaglutide B 3.0 mg/mL PDS290 - somministrazione settimanale
D.3.2	Product code	[EX9536]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	semaglutide
D.3.9.1	CAS number	910463-68-2
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	SEMAGLUTIDE
D.3.9.4	EV Substance Code	SUB32188
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Overweight
Obesity

Sovrappeso
Obesità

E.1.1.1

Medical condition in easily understood language

Overweight
Obesity

Sovrappeso
Obesità

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10033307
E.1.2	Term	Overweight
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10029883
E.1.2	Term	Obesity
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate that semaglutide subcutaneously (s.c) 2.4 mg once-weekly lowers the incidence of major adverse cardiovascular events (MACE) versus semaglutide placebo, both added to standard of care in subjects with established CV disease and overweight or obesity.

Dimostrare che il trattamento con semaglutide s.c. 2,4 mg una volta a settimana riduce l’incidenza di eventi avversi cardiovascolari maggiori (Major Adverse Cardiovascular Event, MACE) in confronto a placebo, in aggiunta allo
standard di cura in soggetti obesi o sovrappeso con patologie cardiovascolari accertate

E.2.2

Secondary objectives of the trial

To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo, both added to standard of care in subjects with established CV disease and overweight or obesity with regards to mortality

Confrontare l’effetto del trattamento con semaglutide s.c. 2,4 mg una volta a settimana rispetto al placebo in aggiunta allo standard di cura in soggetti obesi o sovrappeso con patologie cardiovascolari accertate in termini di
mortalità

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, age equal to or above 45 years at the time of signing informed consent
2. Body mass index (BMI) equal to or above 27 kg/sqm
3. Have established CV disease as evidenced by at least one of the following:
- prior myocardial infarction
- prior stroke (ischemic or haemorrhagic stroke) or
- symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) below 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease

1. soggetti di sesso maschile o femminile, con età maggiore o uguale a 45 anni al momento della firma del modulo di consenso informato
2. Indice di massa corporea (Body Mass Index, BMI) maggiore o uguale a 27 kg/m²
3. Presenza di malattia cardiovascolare accertata, evidenziata da almeno una delle seguenti condizioni:
a. precedente infarto del miocardio
b. precedente ictus (ischemico o ictus emorragico)
c. arteriopatia periferica (Peripheral Arterial Disease, PAD) sintomatica, evidenziata da claudicatio intermittente con indice
caviglia-braccio (Ankle-Brachial Index, ABI) < 0,85 (a riposo), o procedure di rivascolarizzazione arteriosa periferica o amputazione
dovuta a patologia aterosclerotica

E.4

Principal exclusion criteria

1. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
2. HbA1c equal to or above 48 mmol/mol (6.5 %) as measured by the central laboratory at screening
3. History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)

1. Uno qualsiasi dei seguenti eventi: infarto del miocardio, ictus, ricovero per angina pectoris instabile o attacco ischemico
transitorio nei 60 giorni precedenti il giorno dello screening
2. HbA1c maggiore o uguale a 48 mmol/mol (6,5%) allo screening misurata dal laboratorio centrale
3. Storia medica di diabete di tipo 1 o 2 (è consentita la presenza in storia medica di diabete gestazionale)

E.5 End points

E.5.1

Primary end point(s)

Time from randomisation to first occurrence of a composite endpoint consisting of: CV death, non-fatal myocardial infarction, or non-fatal stroke

Il tempo che intercorre tra la randomizzazione e il verificarsi di un endpoint composito costituito da: morte cardiovascolare, infarto del miocardio non fatale o ictus non fatale

E.5.1.1

Timepoint(s) of evaluation of this end point

Time from randomisation to first occurrence of a composite endpoint

Il tempo intercorso dalla randomizzazione al verificarsi del primo endpoint composito

E.5.2

Secondary end point(s)

1. Time from randomisation to CV death
2. Time from randomisation to all-cause death

1. Tempo intercorso dalla randomizzazione al verificarsi di morte cardiovascolare
2. Tempo intercorso dalla randomizzazione al verificarsi di morte per qualsiasi causa

E.5.2.1

Timepoint(s) of evaluation of this end point

1. + 2.: Time from randomisation to event

1. + 2.: Tempo dalla randomizzazione all'evento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

292

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Algeria

Australia

Brazil

Canada

Colombia

India

Israel

Japan

Malaysia

Mexico

Russian Federation

Serbia

South Africa

Taiwan

Thailand

Turkey

Ukraine

United States

Norway

European Union

Argentina

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

11375

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

6125

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

400

F.4.2

For a multinational trial

F.4.2.1

In the EEA

6096

F.4.2.2

In the whole clinical trial

17500

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Non sono previsti programmi per trattamento o assistenza al termine dello studio

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-12-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-12-10

P. End of Trial
P.	End of Trial Status	Ongoing

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