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A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Sponsor: Debiopharm International SA
Summary
The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.
Official title: A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
119
Start Date
2025-11-26
Completion Date
2029-03
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Debio 4126
IM injection, a 12-week extended-release formulation of octreotide
Placebo
IM injection of mannitol suspension
Locations (71)
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
Hospital das Clinicas da UFMG
Minas Gerais, 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
Rigshospitalet, Blegdamsvej 9
Copenhagen, Denmark
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
AOU Federico II Napoli
Naples, Italy
Azienda Ospedale Università di Padova
Padova, 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
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom