Clinical Trials Register

Summary
EudraCT Number:	2021-003612-31
Sponsor's Protocol Code Number:	I8F-MC-GPGV
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:	2022-08-26
Trial 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

2021-003612-31

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in
Pediatric and Adolescent Participants with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin, or Basal Insulin, or Both (SURPASS-PEDS)

Studio randomizzato, in doppio cieco, controllato con placebo, di fase 3 con un' estensione in aperto, per valutare l'efficacia, la sicurezza e la farmacocinetica/farmacodinamica di tirzepatide in soggetti pediatrici e adolescenti con diabete mellito di tipo 2 non adeguatamente controllati con metformina o insulina basale o entrambe (SURPASS-PEDS).

A.3.1

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

Study to Evaluate Tirzepatide Compared to Placebo in Pediatric and Adolescent Participants with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin, or Basal Insulin, or Both

Studio per valutare tirzepatide rispetto al placebo in partecipanti pediatrici e adolescenti con diabete mellito di tipo 2 non adeguatamente controllati con metformina o insulina basale o entrambe.

A.3.2

Name or abbreviated title of the trial where available

SURPASS-PEDS

A.4.1

Sponsor's protocol code number

I8F-MC-GPGV

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05260021

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/311/2019

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ELI LILLY & COMPANY, LILLY CORPORATE CENTER
B.1.3.4	Country	United States
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	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center, DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	46285
B.5.3.4	Country	United States
B.5.4	Telephone number	00000000
B.5.5	Fax number	0000000
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.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	Tirzepatide
D.3.2	Product code	[LY3298176]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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	Tirzepatide
D.3.9.2	Current sponsor code	LY3298176
D.3.9.4	EV Substance Code	SUB198055
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	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	Tirzepatide
D.3.2	Product code	[LY3298176]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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	Tirzepatide
D.3.9.2	Current sponsor code	LY3298176
D.3.9.4	EV Substance Code	SUB198055
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	15
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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: 3
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	Tirzepatide
D.3.2	Product code	[LY3298176]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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	Tirzepatide
D.3.9.2	Current sponsor code	LY3298176
D.3.9.4	EV Substance Code	SUB198055
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	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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: 4
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	Tirzepatide
D.3.2	Product code	[LY3298176]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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	Tirzepatide
D.3.9.2	Current sponsor code	LY3298176
D.3.9.4	EV Substance Code	SUB198055
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	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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 in pre-filled pen
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

Type 2 Diabetes Mellitus (T2DM)

diabete mellito di tipo 2 (T2DM)

E.1.1.1

Medical condition in easily understood language

Diabetes - type 2

Diabete - Tipo 2

E.1.1.2

Therapeutic area

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

MedDRA Classification

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 pooled 5 mg and 10 mg tirzepatide once weekly (QW) is superior to placebo at 30 weeks.

Dimostrare che 5 mg e 10 mg di tirzepatide QW aggregati è superiore al placebo a 30 settimane

E.2.2

Secondary objectives of the trial

To demonstrate that 5 mg and 10 mg tirzepatide QW, analyzed as pooled and/or separate treatment arms, is superior to placebo at 30 weeks.
To assess the effect of 5 mg and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, at 52 weeks.
To assess safety of 5 mg and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, at 30 weeks and at the end of the safety follow-up period.
To compare 5 mg, and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, to
placebo at 30 weeks.
To assess the safety of 5 mg and 10 mg tirzepatide QW, analyzed as separate and pooled arms, at 52
weeks for diabetic retinopathy.
Characterize the pharmacokinetics and pharmacodynamic relationships of tirzepatide.
To assess the effect of 5 mg, and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, on patient reported outcomes at 30 and 52 weeks.

Dimostrare che 5 mge10 mg di tirzepatide QW, analizzati come bracci di trattamento raggruppati e/o separati, sono superiori al placebo a30 settimane;Valutare l'effetto di 5 mge10 mg di tirzepatide QW, analizzati come bracci di trattamento raggruppati e separati, a52 settimane; Valutare la sicurezza di 5mge10 mg di tirzepatide QW, analizzati come bracci di trattamento raggruppati e separati, a 30 settimane e alla fine del periodo di follow-up di sicurezza; Confrontare 5 mge10 mg di tirzepatide QW, analizzati come bracci di trattamento raggruppati e separati, per placebo a 30 settimane; Valutare la sicurezza di 5 mg e 10 mg di tirzepatide QW, analizzati come bracci separati e raggruppati, a 52 settimane per la retinopatia diabetica.
Caratterizzare la farmacocinetica e le relazioni farmacodinamiche di tirzepatide; Valutare l'effetto di 5 mg e 10 mg di tirzepatide QW, analizzati come bracci di trattamento raggruppati e separati, sui pazienti hanno riportato i risultati a 30 e 52 settimane.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participant must be 10 to <18 years of age, at the time of signing the informed consent/assent.
2. Participants have T2DM treated at the time of randomization with lifestyle measures (standardized diet and exercise program), and a. Metformin, or b. Basal insulin, or c. Metformin and basal insulin.
- If metformin is used, the dose must be =1000 mg/day and not more than the locally approved dose
a. Doses of metformin and basal insulin must have been stable (±15% for basal insulin) for at least 90 days prior to Visit 1 and until Visit 3.
3. Have HbA1c >6.5% to =11% at screening visit (determined by central laboratory).
4. Body weight =50 kg and BMI of >85th percentile of the general age and gender-matched population for that country or region.

1. Il partecipante deve avere un'età compresa tra 10 e <18 anni, al momento della sottoscrizione del consenso/assenso informato.
2. I partecipanti hanno T2DM trattato al momento della randomizzazione con misure dello stile di vita (dieta standardizzata e programma di esercizi) e a. metformina, oppure b. Insulina basale, o c. Metformina e insulina basale.
- Se viene utilizzata metformina, la dose deve essere = 1000 mg/die e non superiore alla dose approvata localmente
un. Le dosi di metformina e insulina basale devono essere state stabili (±15% per l'insulina basale) per almeno 90 giorni prima della Visita 1 e fino alla Visita 3.
3. Avere HbA1c da >6,5% a =11% alla visita di screening (determinata dal laboratorio centrale).
4. Peso corporeo = 50 kg e BMI > 85° percentile dell'età generale e della popolazione corrispondente al genere per quel paese o regione.

E.4

Principal exclusion criteria

1. Have T1DM.
2. AFTER the diagnosis of T2DM, have a history of diabetic ketoacidosis or hyperosmolar syndrome.
3. Have diabetes-associated autoantibodies (GAD65 and/or IA2), historically or at Visit 1.
4. Have had >=1 episode of severe hypoglycemia and/or >=1 episode of hypoglycemic unawareness within the last 6 months.
5. Have history of: proliferative diabetic retinopathy, or diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment.
6. Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
7. Had chronic or acute pancreatitis any time prior to study entry (Visit 1).
8. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than Nonalcoholic fatty liver disease (NAFLD), or ALT or AST level >5.0 times the upper limit of the age-adjusted reference range, or Total bilirubin = 1.5 times the upper limit of the age-adjusted reference range (except in the case of Gilbert’s syndrome) as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this study only if their ALT and AST levels are =5.0 times the ULN for the reference range and Total bilirubin level is < 1.5 times the ULN at screening.
9. Have an estimated glomerular filtration rate <45 mL/min/1.73 m2, calculated by Chronic Kidney
Disease-Epidemiology as determined by central laboratory at Visit 1.

1. Avere T1DM.
2. DOPO la diagnosi di T2DM, avere una storia di chetoacidosi diabetica o sindrome iperosmolare.
3. Avere autoanticorpi associati al diabete (GAD65 e/o IA2), storicamente o alla Visita 1.
4. Hanno avuto =1 episodio di ipoglicemia grave e/o =1 episodio di inconsapevolezza ipoglicemica negli ultimi 6 mesi.
5. Avere una storia di: retinopatia diabetica proliferativa o edema maculare diabetico o retinopatia diabetica non proliferativa che richiede un trattamento acuto.
6. Avere una storia familiare o personale di carcinoma midollare della tiroide (MTC) o di sindrome da neoplasie endocrine multiple di tipo 2 (MEN2).
7. Aveva pancreatite cronica o acuta in qualsiasi momento prima dell'ingresso nello studio (Visita 1).
8. Avere epatite acuta o cronica, segni e sintomi di qualsiasi altra malattia del fegato diversa dalla steatosi epatica non alcolica (NAFLD), o livelli di ALT o AST >5,0 volte il limite superiore dell'intervallo di riferimento aggiustato per l'età, o bilirubina totale = 1,5 volte il limite superiore dell'intervallo di riferimento corretto per l'età (tranne nel caso della sindrome di Gilbert) determinato dal laboratorio centrale all'ingresso dello studio; i partecipanti con NAFLD possono partecipare a questo studio solo se i loro livelli di ALT e AST sono = 5,0 volte l'ULN per l'intervallo di riferimento e il livello di bilirubina totale è < 1,5 volte l'ULN allo screening.
9. Avere una velocità di filtrazione glomerulare stimata <45 mL/min/1,73 m2, calcolata da Chronic Kidney
Malattia-Epidemiologia determinata dal laboratorio centrale alla Visita 1.

E.5 End points

E.5.1

Primary end point(s)

To measure a change in hemoglobin A1c (HbA1c) from baseline.

Misurare una variazione dell’emoglobina A1c (HbA1c) rispetto al basale

E.5.1.1

Timepoint(s) of evaluation of this end point

30 weeks.

30 settimane

E.5.2

Secondary end point(s)

Incidence of HbA1c <=6.5%.
Change in body mass index (BMI) standard deviation score (age- and sex-matched) from baseline.
Change in fasting serum glucose (FSG) from baseline.
Change in HbA1c from baseline.
Incidence of HbA1c <7.0%.
Incidence of HbA1c <5.7%.
Change in daily average 6-point self-monitored blood glucose profiles from baseline.
Change from baseline for serum lipid levels.
Incidence of new or worsening of dyslipidemia.
Treatment-emergent adverse events (TEAEs).
Discontinuation of study intervention due to adverse events (AEs).
Adjudicated pancreatic AEs.
Serum calcitonin.
Incidence of allergic, hypersensitivity reactions, and injection site reactions.
Incidence of treatment-emergent anti-drug antibodies to tirzepatide.
Change in systolic and diastolic blood pressure and heart rate from baseline.
Incidence of new or worsening of hypertension.
Incidence of new or worsening of albuminuria.
Occurrence of hypoglycemic events.
Incidence of initiation of rescue therapy for severe persistent hyperglycemia.
Incidence of new or worsening of diabetic neuropathy.
Change from baseline for physical and developmental measures (Height and weight, Height SDS and weight SDS, Waist circumference, and Tanner Staging).
Incidence of new or worsening of diabetic retinopathy or diabetic maculopathy in either eye.
Relationship between tirzepatide exposure and key safety and efficacy measures.
Change from baseline for PedsQL Generic Core Scales and PedsQL (3.2) Diabetic Module from baseline.

Incidenza di HbA1c = 6,5%.
Variazione del punteggio di deviazione standard dell'indice di massa corporea (BMI) (corrispondente a età e sesso) rispetto al basale.
Variazione della glicemia a digiuno (FSG) rispetto al basale.
Variazione dell'HbA1c rispetto al basale.
Incidenza di HbA1c <7,0%.
Incidenza di HbA1c <5,7%.
Variazione dei profili glicemici autocontrollati giornalieri a 6 punti rispetto al basale.
Variazione rispetto al basale per i livelli sierici di lipidi.
Incidenza di nuova o peggioramento della dislipidemia.
Eventi avversi emergenti dal trattamento (TEAE).
Interruzione dell'intervento in studio a causa di eventi avversi (AE).
AE pancreatici aggiudicati.
Calcitonina sierica.
Incidenza di reazioni allergiche, di ipersensibilità e reazioni al sito di iniezione.
Incidenza degli anticorpi anti-farmaco anti-tirzepatide emergenti dal trattamento.
Variazione della pressione arteriosa sistolica e diastolica e della frequenza cardiaca rispetto al basale.
Incidenza di nuovo o peggioramento dell'ipertensione.
Incidenza di nuova o peggioramento dell'albuminuria.
Presenza di eventi ipoglicemizzanti.
Incidenza di inizio della terapia di salvataggio per grave iperglicemia persistente.
Incidenza di nuova o peggioramento della neuropatia diabetica.
Modifica rispetto al basale per le misure fisiche e dello sviluppo (altezza e peso, altezza SDS e peso SDS, circonferenza vita e stadiazione dell'abbronzatura).
Incidenza di nuova o peggioramento della retinopatia diabetica o della maculopatia diabetica in entrambi gli occhi.
Relazione tra esposizione alla tirzepatide e misure chiave di sicurezza ed efficacia.
Modifica rispetto al basale per PedsQL Generic Core Scales e PedsQL (3.2) Modulo per diabetici rispetto al basale

E.5.2.1

Timepoint(s) of evaluation of this end point

At 30 weeks, 52 weeks and when an AE is reported.

A 30 settimane, 52 settimane e quando viene segnalato un evento avverso.

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

Yes

E.6.7

Pharmacodynamic

Yes

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

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

Australia

Brazil

India

Israel

Mexico

United States

France

Italy

United Kingdom

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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

2022-08-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-22

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

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Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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