Clinical Trials Register

Summary
EudraCT Number:	2017-003726-32
Sponsor's Protocol Code Number:	NN9536-4378
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-15
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

2017-003726-32

A.3

Full title of the trial

Two-year effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity

Studio clinico della durata di 2 anni per valutare l’efficacia di semaglutide 2.4 mg in persone in sovrappeso o obese

A.3.1

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

STEP 5: Two-year research study investigating how well semaglutide works in people suffering from overweight or obesity

STEP 5: Studio clinico della durata di 2 anni per valutare l’efficacia di semaglutide in persone in sovrappeso o obese

A.3.2

Name or abbreviated title of the trial where available

NN9536-4378

A.4.1

Sponsor's protocol code number

NN9536-4378

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1202-1740

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	Bagsvaerd
B.5.3.3	Post code	2880
B.5.3.4	Country	Denmark
B.5.4	Telephone number	0018668677178
B.5.5	Fax number	0018668677178
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
D.3.2	Product code	[NN9536]
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.3.9.1	CAS number	910463-68-2
D.3.9.2	Current sponsor code	NN9536
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.IMP: 2
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 1.0 mg/ml PDS290
D.3.2	Product code	[NN9536]
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.3.9.1	CAS number	910463-68-2
D.3.9.2	Current sponsor code	NN9536
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	1
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

Obesity
Overweight

Obesità
Sovrappeso

E.1.1.1

Medical condition in easily understood language

Abnormal or excessive body fat accumulation/excess proportion of total body fat
Overweight

Eccessiva o anormale proporzione del grasso corporeo rispetto sul totale
Sovrappeso

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 compare the two-year effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight.

Valutare l’effetto sul peso corporeo di due anni di trattamento settimanale con semaglutide 2,4 mg in confronto a semaglutide/placebo, in aggiunta a una dieta a ridotto apporto calorico e ad un intensificazione dell’attività fisica in soggetti in sovrappeso od obese.

E.2.2

Secondary objectives of the trial

1. To compare the two-year effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on:
- Cardiovascular risk factors
- Glucose metabolism
2. To compare the one-year effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight
3. To compare the two-year safety and tolerability of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity.

1. Valutare l’effetto di due anni di trattamento settimanale con semaglutide 2,4 mg in confronto a semaglutide/placebo in aggiunta a una dieta a ridotto apporto calorico e ad una intensificazione dell’attività fisica in persone in sovrappeso o obese, su:
- Fattori di rischio cardiovascolari,
- Metabolismo del glucosio.
2. Confrontare l’effetto sul peso corporeo dopo un anno di trattamento settimanale con semaglutide 2,4 mg in confronto a semaglutide/placebo in aggiunta a una dieta a ridotto apporto calorico e ad una intensificazione dell’attività fisica in persone in sovrappeso o obese.
3. Valutare la sicurezza e la tollerabilità di due anni di trattamento settimanale di semaglutide 2,4 mg in confronto a semaglutide/placebo in aggiunta a una dieta a ridotto apporto calorico e ad un incremento dell’attività fisica in persone in sovrappeso o obese.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, age 18 years or older at the time of signing informed consent
2. Body mass index (BMI) equal to or above 30 kg/sqm or equal to or above 27 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
3. History of at least one self-reported unsuccessful dietary effort to lose body weight

1. Sesso maschile o femminile, =18 anni di età al momento della firma del modulo di consenso informato
2. Indice di massa corporea (IMC) =30 kg/m2 o =27 kg/m2 in presenza di almeno una delle seguenti comorbidità (trattate o non trattate) correlate al peso: ipertensione, dislipidemia, apnea ostruttiva del sonno o malattia cardiovascolare
3. Anamnesi di almeno un precedente tentativo fallito, riferito dal paziente, di perdita di peso con una dieta a ridotto apporto calorico

E.4

Principal exclusion criteria

1. HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening
2. A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records

1. Valori di HbA1c = 6,5% (48 mmol/mol) allo screening analizzata dal laboratorio centrale
2. Variazione riferita dal paziente di peso corporeo >5 kg nei 90 giorni prima dello screening indipendentemente da quanto riportato nella cartella clinica

E.5 End points

E.5.1

Primary end point(s)

The primary endpoints addressing the primary objective:
1. Change in body weight (%)
2. Subjects who achieve (yes/no):
- Body weight reduction equal to or above 5%

L'end point primario è in supporto dell'obiettivo primario:
1. Variazione del peso corporeo (%)
2 Soggetti che raggiungono (si/no):
- Riduzione del peso corporeo = 5%

E.5.1.1

Timepoint(s) of evaluation of this end point

1. + 2. From baseline (week 0) to week 104

1. + 2 dal valore basale (settimana 0) fino alla settimana 104

E.5.2

Secondary end point(s)

Confirmatory secondary endpoints:
1. Subjects who achieve (yes/no):
- Body weight reduction equal to or above 10% from baseline (week 0)
- Body weight reduction equal to or above 15% from baseline (week 0)
2. Change in:
- Waist circumference (cm)
- Systolic blood pressure (mmHg);
Confirmatory secondary endpoints: 1. Subjects who achieve (yes/no): - Body weight reduction equal to or above 10% from baseline (week 0) - Body weight reduction equal to or above 15% from baseline (week 0) 2. Change in: - Waist circumference (cm) - Systolic blood pressure (mmHg)

Endpoint secondario di conferma:
1. Soggetti che raggiungono (SI/NO):
- Riduzione del peso corporeo uguale o superiore al 10 % rispetto il valore basale (settimana 0)
- Riduzione del peso corporeo uguale o superiore al 15 % rispetto il valore basale (settimana 0)
2. Variazioni di:
- Riduzione della circonferenza vita (cm)
- Riduzione della pressione sistolica (mmHg); Endpoint secondario di conferma:
1. Soggetti che raggiungono (si/no):
- Riduzione uguale o superiore del 10 % del peso corporeo rispetto il valore basale (alla settimana 0) - riduzione uguale o superiore del 15 % dal valore basale (settimana 0) .
2. Modifiche: circonferenza della visita (cm) - Pressione sistolica (mmHg)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. After 104 weeks
2. From baseline (week 0) to week 104; 1. After 104 weeks 2. From baseline (week 0) to week 104

1. Dopo 104 settimane
2. Dal valore basale (settimana 0) alla settimana 104; 1. Dopo 104 settimane.
2. Dal valore basale (settimana 0) fino alla 104 ° settimana.

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tollerabilità

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

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

Canada

United States

European Union

E.8.7

Trial has a data monitoring committee

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:

270

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

130

F.4.2.2

In the whole clinical trial

300

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

Nessuno

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

2018-09-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-09

P. End of Trial
P.	End of Trial Status	Completed

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