Clinical trial • Phase III • Endocrinology|Rare Disease

OCTREOTIDE for Acromegaly

Phase III trial of OCTREOTIDE for Acromegaly.

Overview

Trial Therapeutic Area
Endocrinology|Rare Disease
Trial Disease
Acromegaly
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
06-03-2025
First CTIS Authorization Date
30-06-2025

Trial design

Randomised, open-label, placebo (ready-to-use suspension resembling 30, 60, or 90 mg debio 4126 doses) and debio 4126 (suspension for injection; octreotide active substance; intramuscular injection; doses resembling 30 mg, 60 mg, or 90 mg; 12-week octreotide formulation).-controlled Phase III trial in Belgium, Denmark, Estonia and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo (ready-to-use suspension resembling 30, 60, or 90 mg Debio 4126 doses) and Debio 4126 (suspension for injection; octreotide active substance; intramuscular injection; doses resembling 30 mg, 60 mg, or 90 mg; 12-week octreotide formulation).
Target Sample Size
100
Trial Duration For Participant
252

Eligibility

Recruits 100 Vulnerable population flag selected. Separate 'Pregnant Participant' informed consent forms are provided (documents titled 'Pregnant Participant ICF' listed alongside main ICFs). Participants are adults (≥18) so consent is provided by the participant; no assent procedures for minors are described in the available documents..

Vulnerable Population
Vulnerable population flag selected. Separate 'Pregnant Participant' informed consent forms are provided (documents titled 'Pregnant Participant ICF' listed alongside main ICFs). Participants are adults (≥18) so consent is provided by the participant; no assent procedures for minors are described in the available documents.

Inclusion criteria

  • {"criterion_text":"- Patients ≥18 years of age"}
  • {"criterion_text":"- Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks."}
  • {"criterion_text":"- IGF-1 at screening ≤1x ULN"}
  • {"criterion_text":"- Acromegaly diagnosis, defined as per protocol"}
  • {"criterion_text":"- Adequate bone marrow, hepatic and renal function"}
  • {"criterion_text":"- To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at W34, or up to W48 when treated with rescue medication"}
  • {"criterion_text":"- Other protocol-defined criteria apply"}

Exclusion criteria

  • {"criterion_text":"- Compression of optic chiasm causing visual defects"}
  • {"criterion_text":"- Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism"}
  • {"criterion_text":"- Other protocol-defined criteria apply"}
  • {"criterion_text":"- Symptomatic cholelithiasis or bile duct dilatation"}
  • {"criterion_text":"- Planned cholecystectomy during the trial duration"}
  • {"criterion_text":"- Acute or chronic pancreatitis"}
  • {"criterion_text":"- Pituitary radiotherapy"}
  • {"criterion_text":"- Uncontrolled hypothyroidism"}
  • {"criterion_text":"- Uncontrolled diabetes"}
  • {"criterion_text":"- Pituitary surgery within 6 months before screening or planned on trial"}
  • {"criterion_text":"- Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamin agonists within 3 months prior to screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of participants with IGF-1 ≤1x ULN at W36, where IGF-1 will be based on the average of 2 samples acquired at W34 and W36. If this average IGF-1 is ≤1x ULN, a participant is classified as a responder","definition_or_measurement_approach":"IGF-1 is based on the average of 2 samples acquired at W34 and W36; if the average IGF-1 ≤ 1x ULN the participant is classified as a responder."}

Secondary endpoints

  • {"endpoint_text":"- Percentage of Participants With IGF-1 ≤1x ULN at W36, in Arm C","definition_or_measurement_approach":"Responder defined by IGF-1 ≤1x ULN at W36 in Arm C (measurement approach analogous to primary endpoint)."}
  • {"endpoint_text":"- Change From Baseline in IGF-1 Values","definition_or_measurement_approach":"Change from baseline IGF-1 values over time (details per statistical analysis plan)."}
  • {"endpoint_text":"- Percent Change From Baseline in IGF-1 Values","definition_or_measurement_approach":"Percent change from baseline in IGF-1 values."}
  • {"endpoint_text":"- Percentage of Participants With IGF-1 ≤1x ULN","definition_or_measurement_approach":"Proportion of participants meeting IGF-1 ≤1x ULN threshold at assessed timepoints."}
  • {"endpoint_text":"- Percentage of Participants With GH Level <1 ng/mL","definition_or_measurement_approach":"Proportion of participants with Growth Hormone (GH) level <1 ng/mL."}
  • {"endpoint_text":"- Change From Baseline in GH Values","definition_or_measurement_approach":"Change from baseline in GH values over time."}
  • {"endpoint_text":"- Mean Logarithm With Base 10 (Log10) Change From Baseline in GH Values","definition_or_measurement_approach":"Mean log10 change from baseline in GH values."}
  • {"endpoint_text":"- Percentage of Participants With GH Value per Category (<1; ≥1 and <2.5; ≥2.5 (ng/mL)","definition_or_measurement_approach":"Categorical distribution of GH values by specified thresholds."}
  • {"endpoint_text":"- Number of Participants With at Least one Treatment-Emergent Adverse Event (TEAE), in Arms A and B, up to W36","definition_or_measurement_approach":"Count of participants with ≥1 TEAE in Arms A and B up to Week 36."}
  • {"endpoint_text":"- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs, Electrocardiogram (ECG), and Pituitary Tumor Size, in Arms A and B, up to W36","definition_or_measurement_approach":"Number of participants with clinically significant abnormalities in labs, vitals, ECG, and pituitary tumor size up to Week 36."}
  • {"endpoint_text":"- Number of Participants With at Least one TEAE in Arms A, B and C","definition_or_measurement_approach":"Count of participants with ≥1 TEAE in any arm (A, B, C)."}
  • {"endpoint_text":"- Time-at-Risk Exposure-Adjusted Incidence Rate for TEAEs","definition_or_measurement_approach":"Exposure-adjusted incidence rate for TEAEs (time-at-risk adjusted)."}
  • {"endpoint_text":"- Total Participant-Years at-Risk for TEAEs","definition_or_measurement_approach":"Total participant-years at risk for TEAEs."}
  • {"endpoint_text":"- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs, ECG, and Pituitary Tumor Size in Arms A, B and C","definition_or_measurement_approach":"Number of participants with clinically significant abnormalities in labs, vitals, ECG, and pituitary tumor size across all arms."}
  • {"endpoint_text":"- Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment","definition_or_measurement_approach":"Investigator assessment of erythema, swelling and induration at injection site to evaluate local tolerability."}
  • {"endpoint_text":"- Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score","definition_or_measurement_approach":"Pain at injection site measured using Visual Analog Scale (VAS) score (patient-facing VAS questionnaires provided)."}
  • {"endpoint_text":"- Percentage of Participants Taking Rescue Medication","definition_or_measurement_approach":"Proportion of participants who required rescue medication during the study."}
  • {"endpoint_text":"- PK parameters of Debio 4126, including but not limited to octreotide concentration at the end of the 12-week Treatment Interval (Ctrough)","definition_or_measurement_approach":"Pharmacokinetic parameters including octreotide concentration at end of 12-week treatment interval (Ctrough) and other standard PK metrics."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
100
Recruitment Window Months
45
Consent Approach
Informed consent obtained from adult participants (all subjects ≥18 years). Separate 'Pregnant Participant' ICFs are provided alongside main ICFs. Subject information and ICF documents are provided in multiple country/language versions (documents listed in English, French, Dutch, German, Spanish, Italian, Hungarian, Polish, Romanian, Swedish, Slovak, Bulgarian, Estonian, Latvian, Lithuanian and Russian where applicable). Consent is provided by the participant; no assent procedures for minors are described.

Methods

  • Country-specific K1/K2 recruitment materials (flyers, brochures) prepared for multiple participating Member States (examples: K1/K2 documents listed for BE, DK, EE, FR, DE, HU, LV, LT, RO, ES, SE, PL, AT, IT, BG, SK).
  • Email communications to potential participants (L2 'Email communication' documents).
  • Scout / ScoutPass materials (Reloadable ScoutPass Brochure, Scout Brochure, Scout Study Brochure) as recruitment/engagement materials.
  • GP letters (country-specific, e.g., Hungary 'GP Letter')
  • Site-based recruitment using site contact points (trial sites and site investigators listed for each country).
  • Patient concierge / travel reimbursement services (third-party 'Scout Clinical' listed with role 'Patient concierge services/travel reimbursement').

Geography

Total Number Of Sites
50
Total Number Of Participants
100

Belgium

Earliest CTIS Part Ii Submission Date
30-05-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
31
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Endocrinology
Principal Investigator Name
Guy T'Sjoen
Principal Investigator Email
guy.tsjoen@ugent.be
Contact Person Name
Guy T'Sjoen
Contact Person Email
guy.tsjoen@ugent.be

Denmark

Earliest CTIS Part Ii Submission Date
18-06-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
12
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Kobenhavns Universitet
Department Name
Department of Nephrology and Endocrinology
Principal Investigator Name
Mikkel Andreasen
Principal Investigator Email
mikkel.andreassen.01@regionh.dk
Contact Person Name
Mikkel Andreasen
Site Name
Region Sjaelland
Department Name
Clinic for Pituitary Disorders, Department of Medicine
Principal Investigator Name
Jesper Krogh
Principal Investigator Email
jekrog@regionsjaelland.dk
Contact Person Name
Jesper Krogh
Contact Person Email
jekrog@regionsjaelland.dk

Estonia

Earliest CTIS Part Ii Submission Date
03-06-2025
Latest Decision Or Authorization Date
02-07-2025
Processing Time Days
29
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
East Tallinn Central Hospital
Department Name
Endocrinology
Principal Investigator Name
Ülle Jakovlev
Principal Investigator Email
ulle.jakovlev@itk.ee
Contact Person Name
Ülle Jakovlev
Contact Person Email
ulle.jakovlev@itk.ee
Site Name
North Estonia Medical Centre Foundation
Department Name
Endocrinology
Principal Investigator Name
Anu Ambos
Principal Investigator Email
anu.ambos@regionaalhaigla.ee
Contact Person Name
Anu Ambos
Contact Person Email
anu.ambos@regionaalhaigla.ee

France

Earliest CTIS Part Ii Submission Date
03-06-2025
Latest Decision Or Authorization Date
03-07-2025
Processing Time Days
30
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Endocrinology
Principal Investigator Name
Frédéric Castinetti
Principal Investigator Email
frederic.castinetti@ap-hm.fr
Contact Person Name
Frédéric Castinetti
Contact Person Email
frederic.castinetti@ap-hm.fr
Site Name
Hospices Civils De Lyon
Department Name
Endocrinology, Diabetology and Metabolic disease "A"
Principal Investigator Name
Gerald Raverot
Principal Investigator Email
gerald.raverot@chu-lyon.fr
Contact Person Name
Gerald Raverot
Contact Person Email
gerald.raverot@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Endocrinology, Diabetology and Nutrition
Principal Investigator Name
Amandine Ferriere
Principal Investigator Email
amandine.ferriere@chu-bordeaux.fr
Contact Person Name
Amandine Ferriere
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Endocrinology, Diabetology and Metabolic disease
Principal Investigator Name
Céline Mouly
Principal Investigator Email
mouly.ce@chu-toulouse.fr
Contact Person Name
Céline Mouly
Contact Person Email
mouly.ce@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Endocrinology and Reproductive diseases
Principal Investigator Name
Philippe Chanson
Principal Investigator Email
philippe.chanson@aphp.fr
Contact Person Name
Philippe Chanson
Contact Person Email
philippe.chanson@aphp.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Endocrinology, Diabetology and Nutrition
Principal Investigator Name
Claire Briet
Principal Investigator Email
claire.briet@chu-angers.fr
Contact Person Name
Claire Briet
Contact Person Email
claire.briet@chu-angers.fr

Germany

Earliest CTIS Part Ii Submission Date
03-06-2025
Latest Decision Or Authorization Date
02-07-2025
Processing Time Days
29
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Endocrinology
Principal Investigator Name
Christian Strasburger
Principal Investigator Email
christian.strasburger@charite.de
Contact Person Name
Christian Strasburger
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Endocrinology and diabetes
Principal Investigator Name
Martin Fassnacht
Principal Investigator Email
Fassnacht_M@ukw.de
Contact Person Name
Martin Fassnacht
Contact Person Email
Fassnacht_M@ukw.de
Site Name
Ludwig-Maximilians-Universitaet Muenchen
Department Name
Medical Clinic and Polyclinic IV
Principal Investigator Name
Katharina Schilbach
Principal Investigator Email
katharina.schilbach@med.uni-muenchen.de
Contact Person Name
Katharina Schilbach

Hungary

Earliest CTIS Part Ii Submission Date
05-05-2025
Latest Decision Or Authorization Date
02-07-2025
Processing Time Days
58
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
University Of Szeged
Department Name
Department of Internal Medicine
Principal Investigator Name
Sandor Magony
Principal Investigator Email
magony.sandor@med.u-szeged.hu
Contact Person Name
Sandor Magony
Contact Person Email
magony.sandor@med.u-szeged.hu
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Division of Endocrinology
Principal Investigator Name
Erika Hubina
Principal Investigator Email
ehubina@gmail.com
Contact Person Name
Erika Hubina
Contact Person Email
ehubina@gmail.com
Site Name
Semmelweis University
Department Name
Department of Internal Medicine and Oncology, Endocronology
Principal Investigator Name
Miklos Toth
Principal Investigator Email
toth.miklos@med.semmelweis-univ.hu
Contact Person Name
Miklos Toth

Latvia

Earliest CTIS Part Ii Submission Date
03-06-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
28
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Pauls Stradins Clinical University Hospital
Department Name
Science department
Principal Investigator Name
Valdis Pirags
Principal Investigator Email
pirags@latnet.lv
Contact Person Name
Valdis Pirags
Contact Person Email
pirags@latnet.lv

Lithuania

Earliest CTIS Part Ii Submission Date
19-06-2025
Latest Decision Or Authorization Date
02-07-2025
Processing Time Days
13
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Vaidotas Urbanavicius Sole Proprietor Enterprise
Department Name
Endocrinology
Principal Investigator Name
Vaidotas Urbanavicius
Principal Investigator Email
Vaidotas.Urbanavicius@santa.lt
Contact Person Name
Vaidotas Urbanavicius
Contact Person Email
Vaidotas.Urbanavicius@santa.lt
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Endocrinology department
Principal Investigator Name
Birute Zilaitiene
Principal Investigator Email
birute.zilaitiene@kaunoklinikos.lt
Contact Person Name
Birute Zilaitiene

Romania

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
34
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Delta Health Care S.R.L.
Principal Investigator Name
Corin Badiu
Principal Investigator Email
badicrin@yahoo.co.uk
Contact Person Name
Corin Badiu
Contact Person Email
badicrin@yahoo.co.uk
Site Name
National Institute Of Endocrinology C.I. Parhon
Department Name
Endocrinology II
Principal Investigator Name
Ionela Florina Baciu
Principal Investigator Email
ionela.baciu@parhon.ro
Contact Person Name
Ionela Florina Baciu
Contact Person Email
ionela.baciu@parhon.ro
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Endocrinology Department
Principal Investigator Name
Carmen Georgescu
Principal Investigator Email
c_e_georgescu@yahoo.com
Contact Person Name
Carmen Georgescu
Contact Person Email
c_e_georgescu@yahoo.com

Sweden

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
30
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Karolinska University Hospital
Department Name
ME Endokrinologi
Principal Investigator Name
Charlotte Höybye
Principal Investigator Email
charlotte.hoybye@regionstockholm.se
Contact Person Name
Charlotte Höybye
Site Name
Uppsala University Hospital
Department Name
Endrinology and diabetes department
Principal Investigator Name
Britt Edén Engström
Principal Investigator Email
britt.eden_engstrom@medsci.uu.se
Contact Person Name
Britt Edén Engström

Poland

Earliest CTIS Part Ii Submission Date
02-06-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
35
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Centrum Medyczne Intercor Sp. z o.o.
Department Name
Specialist clinics
Principal Investigator Name
Roman Junik
Principal Investigator Email
intercor@farmepo.com
Contact Person Name
Roman Junik
Contact Person Email
intercor@farmepo.com
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Endocrinology, Metabolism and Internal Diseases
Principal Investigator Name
Marek Ruchala
Principal Investigator Email
mruchala@ump.edu.pl
Contact Person Name
Marek Ruchala
Contact Person Email
mruchala@ump.edu.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Nuclear Medicine and Endocrine Oncology
Principal Investigator Name
Lukasz Kluczinski
Principal Investigator Email
Lukasz.kluczynski@gliwice.nio.gov.pl
Contact Person Name
Lukasz Kluczinski
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Endocrinology, Oncological Endocrinology, Nuclear Medicine, and Internal Diseases
Principal Investigator Name
Aleksandra Gilis-Januszewska
Principal Investigator Email
myjanusz@cyf-kr.edu.pl
Contact Person Name
Aleksandra Gilis-Januszewska
Contact Person Email
myjanusz@cyf-kr.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Endocrinology and internal medicine
Principal Investigator Name
Marek Bolanowski
Principal Investigator Email
Marek.bolanowski@umw.edu.pl
Contact Person Name
Marek Bolanowski
Contact Person Email
Marek.bolanowski@umw.edu.pl

Austria

Earliest CTIS Part Ii Submission Date
16-06-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
21
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Medicine III (Division of Endocrinology and Metabolism)
Principal Investigator Name
Greisa Vila
Principal Investigator Email
greisa.vila@meduniwien.ac.at
Contact Person Name
Greisa Vila
Contact Person Email
greisa.vila@meduniwien.ac.at
Site Name
Medical University Of Graz
Department Name
Division of Endocrinology and Diabetology
Principal Investigator Name
Barbara Obermayer-Pietsch
Principal Investigator Email
barbara.obermayer@medunigraz.at
Contact Person Name
Barbara Obermayer-Pietsch

Italy

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
19
Number Of Sites
9
Number Of Participants
16

Sites

Site Name
Azienda Ospedaliera di Padova
Department Name
Complex Operative Unit Clinica Medica 3
Principal Investigator Name
Pietro Maffei
Principal Investigator Email
pietro.maffei@unipd.it
Contact Person Name
Pietro Maffei
Contact Person Email
pietro.maffei@unipd.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Operative Unit of Endocrinology
Principal Investigator Name
Andrea Giustina
Principal Investigator Email
Giustina.andrea@hsr.it
Contact Person Name
Andrea Giustina
Contact Person Email
Giustina.andrea@hsr.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Complex Operative Unit Endocrinology and Diabetology
Principal Investigator Name
Antonio Bianchi
Principal Investigator Email
antonio.bianchi@policlinicogemelli.it
Contact Person Name
Antonio Bianchi
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Complex Structure of Endocrinology
Principal Investigator Name
Iacopo Chiodini
Principal Investigator Email
iacopo.chiodini@gmail.com
Contact Person Name
Iacopo Chiodini
Contact Person Email
iacopo.chiodini@gmail.com
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Endocrinology
Principal Investigator Name
Giovanna Mantovani
Principal Investigator Email
giovanna.mantovani@policlinico.mi.it
Contact Person Name
Giovanna Mantovani
Site Name
University Hospital Of Ferrara
Department Name
Section of Endocrinology and Metabolic Diseases
Principal Investigator Name
Maria Chiara Zatelli
Principal Investigator Email
ztlmch@unife.it
Contact Person Name
Maria Chiara Zatelli
Contact Person Email
ztlmch@unife.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Department of Internal Medicine, Endocrinology Unit
Principal Investigator Name
Federico Gatto
Principal Investigator Email
federico.gatto@hsanmartino.it
Contact Person Name
Federico Gatto
Contact Person Email
federico.gatto@hsanmartino.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Division of Endocrinology, Diabetology and Metabolism
Principal Investigator Name
Silvia Grottoli
Principal Investigator Email
Silvia.grottoli@unito.it
Contact Person Name
Silvia Grottoli
Contact Person Email
Silvia.grottoli@unito.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Complex Unit of Endocrinology and Metabolic Diseases
Principal Investigator Name
Annamaria Colao
Principal Investigator Email
colao@unina.it
Contact Person Name
Annamaria Colao
Contact Person Email
colao@unina.it

Bulgaria

Earliest CTIS Part Ii Submission Date
10-06-2025
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
24
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
Department Name
First Clinic of Endocrinology and Metabolic Diseases
Principal Investigator Name
Vladimir Vasilev
Principal Investigator Email
drvvv@mail.bg
Contact Person Name
Vladimir Vasilev
Contact Person Email
drvvv@mail.bg

Spain

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
33
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Hospital Universitario De La Ribera
Department Name
Endocrinology and Nutrition
Principal Investigator Name
Carmen Fajardo Montañana
Principal Investigator Email
fajardo_carmon@gva.es
Contact Person Name
Carmen Fajardo Montañana
Contact Person Email
fajardo_carmon@gva.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Endocrinology and Nutrition
Principal Investigator Name
Betina Loys Biagetti Biagetti
Principal Investigator Email
betinaloys.biagetti@vallhebron.cat
Contact Person Name
Betina Loys Biagetti Biagetti
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Endocrinology
Principal Investigator Name
Queralt Asla Roca
Principal Investigator Email
QAsla@santpau.cat
Contact Person Name
Queralt Asla Roca
Contact Person Email
QAsla@santpau.cat
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Endocrinology and Nutrition
Principal Investigator Name
Rocio Villar Taibo
Principal Investigator Email
rotaibo22@gmail.com
Contact Person Name
Rocio Villar Taibo
Contact Person Email
rotaibo22@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Endocrinology and Nutrition
Principal Investigator Name
Eider Pascual Corrales
Principal Investigator Email
eider.pascual@salud.madrid.org
Contact Person Name
Eider Pascual Corrales
Contact Person Email
eider.pascual@salud.madrid.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Endocrinology and Nutrition
Principal Investigator Name
Eva Maria Venegas Moreno
Principal Investigator Email
evam.venegas.sspa@juntadeandalucia.es
Contact Person Name
Eva Maria Venegas Moreno
Site Name
Hospital Germans Trias I Pujol
Department Name
Endocrinology and Nutrition
Principal Investigator Name
Federico Vazquez San Miguel
Principal Investigator Email
fvazquezs.germanstrias@gencat.cat
Contact Person Name
Federico Vazquez San Miguel

Slovakia

Earliest CTIS Part Ii Submission Date
03-06-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
27
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Narodny Endokrinologicky A Diabetologicky Ustav
Department Name
Department of Endocrinology
Principal Investigator Name
Peter Vaňuga
Principal Investigator Email
peter.vanuga@nedu.sk
Contact Person Name
Peter Vaňuga
Contact Person Email
peter.vanuga@nedu.sk

Sponsor

Primary sponsor

Full Name
Debiopharm International S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Pharma Bio-Research Group
Responsibilities
sponsorDuties codes: 4
Name
Drug Development Solutions Limited
Responsibilities
sponsorDuties codes: 4
Name
Eresearchtechnology Inc.
Responsibilities
ECG (electrocardiogram) (sponsorDuties code 15)
Name
Allucent (UK) Limited
Responsibilities
sponsorDuties codes: 1,12,13,2,5
Name
Acm Global Central Laboratory Limited
Responsibilities
sponsorDuties codes: 4 (central laboratory)
Name
Medidata Solutions Inc.
Responsibilities
sponsorDuties code: 7 (electronic data services)
Name
Cytel Inc.
Responsibilities
sponsorDuties codes: 10,6 (statistical/other services)
Name
4G Clinical B.V.
Responsibilities
sponsorDuties code: 3
Name
A4p Consulting Limited
Responsibilities
Bioanalytical Monitoring (sponsorDuties code 15)
Name
SGS Belgium
Responsibilities
Safety case processing (sponsorDuties code 15)
Name
Scout Clinical
Responsibilities
Patient concierge services/travel reimbursement (sponsorDuties code 15)

Third parties

  • {"country":"Netherlands","full_name":"Pharma Bio-Research Group","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties: code 15 (ECG (electrocardiogram))","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Allucent (UK) Limited","duties_or_roles":"sponsorDuties codes: 1,12,13,2,5","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"sponsorDuties codes: 10,6","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Calvagone","duties_or_roles":"sponsorDuties code: 15 (Population PK-PD analysis)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Ludwig-Maximilians-Universitaet Muenchen","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Educational Institution"}
  • {"country":"United Kingdom","full_name":"A4p Consulting Limited","duties_or_roles":"sponsorDuties code: 15 (Bioanalytical Monitoring)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"sponsorDuties code: 15 (Safety case processing)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties code: 15 (Patient concierge services/travel reimbursement)","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Debio 4126
Active Substance
OCTREOTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
Intramuscular injection
Authorisation Status
prodAuthStatus 1 (as provided in productDictionaryInfo)
Starting Dose
30 mg
Dose Levels
30 mg | 60 mg | 90 mg
Frequency
Every 12 weeks (12-week octreotide formulation, as described in trial title)
Maximum Dose
90 mg

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