Clinical Trials Register

Summary
EudraCT Number:	2009-010198-19
Sponsor's Protocol Code Number:	CLCQ908A2204
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-04-28
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2009-010198-19

A.3

Full title of the trial

Estudio de Fase 2, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, de diseño adaptativo y de 12 semanas de seguimiento, para evaluar la seguridad y eficacia de LCQ908 en la reducción de peso y la reducción del colesterol LDL en pacientes con obesidad y dislipidemia mixta

A.4.1

Sponsor's protocol code number

CLCQ908A2204

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Farmaceutica SA
B.1.3.4	Country	Spain
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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.3.2	Product code	LCQ908
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	LCQ908
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
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	Information not present in EudraCT
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	Information not present in EudraCT
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.3.2	Product code	LCQ908
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	LCQ908
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
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	Information not present in EudraCT
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	Information not present in EudraCT
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.3.2	Product code	LCQ908
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	LCQ908
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
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	Information not present in EudraCT
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	Information not present in EudraCT
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	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Obesidad y dislipidemia mixta

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10029883
E.1.2	Term	Obesity

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10058110
E.1.2	Term	Dyslipidemia

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Los objetivos principales del estudio son 1) evaluar la eficacia potencial y la respuesta a la dosis de LCQ908 como terapia para el tratamiento de la obesidad y 2) evaluar la posible eficacia y respuesta a la dosis de LCQ908 como un tratamiento para la dislipidemia asociada al síndrome metabólico.

E.2.2

Secondary objectives of the trial

Los objetivos secundarios consistirán en evaluar los efectos de LCQ908 en el estado de pérdida de peso (≥ 5%, o < 5%), los cambios en la circunferencia de la cintura, la sensibilidad a la insulina, y los elementos específicos del perfil lipídico incluidos los restos de quilomicrones y los subtipos de HDL.
Los objetivos adicionales consistirán en evaluar el efecto de otras características del síndrome metabólico incluidas la presión arterial y los marcadores de la inflamación. Finalmente, un subestudio con RM para determinar el efecto de LCQ908 en la fracción de grasa hepática (FGH) proporcionará datos piloto con respecto a otros posibles beneficios terapéuticos en pacientes con enfermedad del hígado graso no alcohólica (EHGNA) o esteatohepatitis no alcohólica (EHNA).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Criterios de inclusión (evaluados durante la selección)
1. Pacientes que otorguen su consentimiento informado por escrito para participar en el estudio, antes de que se realice ninguna actividad relacionada con el estudio, y que probablemente cumplan todos los requisitos del estudio, incluidas las guías alimenticias.
2. De 18 a 75 años de edad, ambas edades inclusive.
3. Hombres, mujeres estériles, y mujeres que no estén en edad fértil. Las mujeres deben (a) estar en estado postmenopáusico, que se define como >48 años de edad con 12 meses de amenorrea natural (es decir, espontánea) o >42 años de edad con >6 meses de amenorrea espontánea con niveles de FSH sérico > 30 mUI/mL y de estradiol <30 pg/ml; (b) haberse sometido a una ooforectomía bilateral quirúrgica con o sin histerectomía 6 semanas antes; o (c) presentar antecedentes documentados de ligadura de trompas al menos un año antes de la selección.
4. Pacientes con antecedentes de sobrepeso durante un año o más con un índice de masa corporal (IMC) de 30 a 42 kg/m2, ambos incluidos.
5. Peso corporal en la Visita 1 que esté dentro del 5% del peso que ellos mismos hayan notificado durante los últimos tres meses y que acepten seguir la dieta que recomienda el estudio (se les asesorará durante la selección) y practicar ejercicio regularmente durante todo el estudio. Los pacientes no deberán haber participado en ningún programa formal para perder peso durante los 3 meses previos a la Visita 1 de selección.
6. Pacientes con dislipidemia mixta en ayunas en la primera visita de selección que incluya:
- niveles elevados de colesterol LDL de 2,6 a 4,14 mmol/L (100-160 mg/dl), ambos incluidos
y o bien
- niveles de triglicéridos en ayunas de 1,7 a 5,0 mmol/L (150-520 mg/dl), ambos incluidos
o
- niveles de colesterol HDL <1,1 mmol/L (<42 mg/dl) en hombres y <1,3 mmol/L (<50 mg/dl) en mujeres
7. Los pacientes que estén recibiendo estatinas deberán cumplir los criterios de dislipidemia mientras continúen con esta terapia y deberán haber tomado una dosis estable durante al menos 2 meses antes de la Visita 1 de selección de seguridad y lípidos en ayunas. Deberán estar de acuerdo en mantener la misma dosis de estatinas durante todo el estudio.
8. Los pacientes que no hayan recibido terapias de reducción lipídica con derivados del ácido fíbrico o nicotínico (niacina) en los 2 meses anteriores a la Visita 1 serán elegibles para la selección siempre y cuando cumplan todos los demás criterios. Los pacientes que estén tomando aceites de pescado de venta sin receta, aceites de pescado de venta con receta (Lovaza hasta 4 g/día) o cualquier otro producto natural para la reducción de lípidos podrán mantener la dosis siempre y cuando cumplan los demás criterios de inclusión.

E.4

Principal exclusion criteria

Criterios de exclusión clave (evaluados durante la selección)
1. Antecedentes de diabetes tipo 1 o diabetes tipo 2 diagnosticada, u otras formas de diabetes mellitus. Las mujeres con antecedentes de diabetes gestacional que se presente durante los 5 años previos a la selección o antes, serán elegibles si cumplen los demás criterios metabólicos.
2. Glucosa plasmática en ayunas > 7,0 mmol/L (>126 mg/dl) o HbA1c >6,5 %
3. Trastornos endocrinos conocidos que den lugar a obesidad incluidos los trastornos hipotalámicos, enfermedad de Cushing o hipotiroidismo diagnosticado recientemente (en los 6 meses anteriores)
4. Síndromes de obesidad genética, incluido el Síndrome de Prader-Willi
5. Síndromes de dislipidemia que precisen ácido nicotínico o fibratos para su control o que necesiten tratamiento acelerado, que incluyan triglicéridos >5,0 mmol/L (520 mg/dl) y colesterol LDL > 4,14 nmol (160 mg/dl)
6. Pacientes con quilomicronemia conocida Tipo I o Tipo V
7. En los pacientes a quienes se considere incluir en el subestudio de RM: claustrofobia, circunferencia de la cintura que exceda el diámetro del equipo de RM, y presencia de implantes ferromagnéticos, tales como marcapasos antiguos.
Para el resto de criterios de exclusión por favor dirijirse al protocolo.

E.5 End points

E.5.1

Primary end point(s)

Las variables de eficacia principales son el cambio porcentual en el peso desde la basal y el cambio porcentual en los niveles de colesterol LDL en ayunas desde la basal a las 12 semanas

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

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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.8.3

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

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	Information not present in EudraCT
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
F.3.3.3	Pregnant women	Information not present in EudraCT
F.3.3.4	Nursing women	Information not present in EudraCT
F.3.3.5	Emergency situation	Information not present in EudraCT
F.3.3.6	Subjects incapable of giving consent personally	Information not present in EudraCT
F.3.3.7	Others	Information not present in EudraCT
F.4 Planned number of subjects to be included
F.4.1	In the member state	25
F.4.2	For a multinational trial
F.4.2.1	In the EEA	200
F.4.2.2	In the whole clinical trial	450

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

2009-07-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-06-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-05-06

Select Country:	Select Age Range:
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:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials