A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
NCT ID: NCT06930625
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
119 participants
INTERVENTIONAL
2025-11-26
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: Debio 4126
During Period 1 (double-blind treatment period), participants will receive an intramuscular (IM) injection of Debio 4126 once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication.
Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
Debio 4126
IM injection, a 12-week extended-release formulation of octreotide
Arm B: Placebo + Debio 4126
During Period 1 (double-blind treatment period), participants will receive an IM injection of placebo once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication.
Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
Debio 4126
IM injection, a 12-week extended-release formulation of octreotide
Placebo
IM injection of mannitol suspension
Arm C: Debio 4126 (Open-Label Treatment Period)
During the Treatment Period, participants will receive an IM injection of Debio 4126 once every 12 weeks over a total of between 60 and 96 weeks (between 5 and 8 injections in total).
Debio 4126
IM injection, a 12-week extended-release formulation of octreotide
Interventions
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Debio 4126
IM injection, a 12-week extended-release formulation of octreotide
Placebo
IM injection of mannitol suspension
Eligibility Criteria
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Inclusion Criteria
2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
3. IGF-1 at screening ≤1x ULN
4. Acromegaly diagnosis, defined as per protocol
5. Adequate bone marrow, hepatic and renal function
6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication
7. Other protocol-defined criteria apply
Exclusion Criteria
2. Symptomatic cholelithiasis or bile duct dilatation
3. Planned cholecystectomy during the trial duration
4. Acute or chronic pancreatitis
5. Pituitary radiotherapy
6. Uncontrolled hypothyroidism
7. Uncontrolled diabetes
8. Pituitary surgery within 6 months before screening or planned on trial
9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening
10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
11. Other protocol-defined criteria apply
18 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
Harvard Medical School
Boston, Massachusetts, United States
Washington University-School of Medicine
St Louis, Missouri, United States
Palm Research Center Inc
Las Vegas, Nevada, United States
The Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University Graz
Graz, , Austria
Medizinische Universitaet Wien - Division of Endocrinology and Metabolism
Vienna, , Austria
UZ Gent
Ghent, , Belgium
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, , Brazil
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM)
Fortaleza, , Brazil
Instituto Estadual do Cérebro Paulo Niemeyer (IECPN)
Rio de Janeiro, , Brazil
Hospital das Clinicas - University of Sao Paulo Medical School
São Paulo, , Brazil
University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD
Sofia, , Bulgaria
Zealand University Hospital
Køge, , Denmark
East Tallinn Central Hospital
Tallinn, , Estonia
North Estonia Medical Centre Foundation
Tallinn, , Estonia
CHU d'Angers
Angers, , France
Hospices Civils de Lyon
Bron, , France
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille, , France
Hopital Haut-Leveque
Pessac, , France
CHU Toulouse - Hôpital Larrey
Toulouse, , France
Charité Universitätsmedizin Berlin
Berlin, , Germany
Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi
Munich, , Germany
Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog
Würzburg, , Germany
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, , Hungary
Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia
Budapest, , Hungary
University of Szeged Faculty of Medicine
Szeged, , Hungary
Bnai Zion Medical Center
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Rabin Medical Center - Beilinson Campus
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda ospedaliero Universitaria di Ferrara
Ferrara, , Italy
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedale Università di Padova
Padua, , Italy
Fondazione Policlinico Universitario A Gemelli
Roma, , Italy
University of Torino
Torino, , Italy
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Lithuanian Health Science University Hospital Kauno klinikos
Kaunas, , Lithuania
Vaidotas Urbanavicius Sole Proprietor Enterprise
Vilnius, , Lithuania
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
Gliwice, , Poland
Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medical Sciences
Poznan, , Poland
Uniwersytecki Szpital Kliniczny we Wroclawiu
Wroclaw, , Poland
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, , Romania
Delta Health Care
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, , Romania
University Clinical Center of Serbia
Belgrade, , Serbia
University Clinical Center of Serbia
Belgrade, , Serbia
Narodni endokrinologicky a diabetologicky ustav
Ľubochňa, , Slovakia
Hosiptal Universitario de la Ribera
Alzira, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Karolinska University Hospital
Stockholm, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-516616-24
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1310-8427
Identifier Type: OTHER
Identifier Source: secondary_id
Debio 4126-301
Identifier Type: -
Identifier Source: org_study_id