A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Start Date
11/26/2025
Completion Date
3/1/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Debio 4126
Placebo
Conditions
Locations
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Northwestern University
Chicago, Illinois 60611
United States
Harvard Medical School
Boston, Massachusetts 01952
United States
Washington University-School of Medicine
St Louis, Missouri 63110
United States
Palm Research Center Inc
Las Vegas, Nevada 89128
United States
NYU Grossman School of Medicine
New York, New York 10016
United States
The Cleveland Clinic
Cleveland, Ohio 44195
United States
The Ohio State University
Columbus, Ohio 43210
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Medical University Graz
Graz, A-8036
Austria
Medizinische Universitaet Wien - Division of Endocrinology and Metabolism
Vienna, 1090
Austria
UZ Gent
Ghent, 9000
Belgium
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, 80030-110
Brazil
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM)
Fortaleza, 60430-275
Brazil
Hospital das Clinicas da UFMG
Minas Gerais, 30130-100
Brazil
Instituto Estadual do Cérebro Paulo Niemeyer (IECPN)
Rio de Janeiro, 20231-092
Brazil
Hospital das Clinicas - University of Sao Paulo Medical School
São Paulo, 5403000
Brazil
University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD
Sofia, 1431
Bulgaria
Rigshospitalet, Blegdamsvej 9
Copenhagen, DK-2100
Denmark
Zealand University Hospital
Køge, 4600
Denmark
East Tallinn Central Hospital
Tallinn, 10138
Estonia
North Estonia Medical Centre Foundation
Tallinn, 13419
Estonia
CHU d'Angers
Angers, 49933
France
Hospices Civils de Lyon
Bron, 69677
France
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille, 13005
France
Hopital Haut-Leveque
Pessac, 33600
France
CHU Toulouse - Hôpital Larrey
Toulouse, 31059
France
Charité Universitätsmedizin Berlin
Berlin, 10117
Germany
Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi
Munich, 80336
Germany
Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog
Würzburg, 97080
Germany
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083
Hungary
Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia
Budapest, 1134
Hungary
University of Szeged Faculty of Medicine
Szeged, 6725
Hungary
Bnai Zion Medical Center
Haifa, 3104802
Israel
Rambam Health Care Campus
Haifa, 3109601
Israel
Rabin Medical Center - Beilinson Campus
Petah Tikva, 49100
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Israel
Azienda ospedaliero Universitaria di Ferrara
Ferrara, 44124
Italy
Ospedale Policlinico San Martino IRCCS
Genova, 16132
Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Milan, 20122
Italy
IRCCS Ospedale San Raffaele
Milan, 20132
Italy
AOU Federico II Napoli
Naples, 80131
Italy
Azienda Ospedale Università di Padova
Padova, 35124
Italy
Fondazione Policlinico Universitario A Gemelli
Roma, 00168
Italy
University of Torino
Torino, 10126
Italy
Pauls Stradins Clinical University Hospital
Riga, LV-1002
Latvia
Lithuanian Health Science University Hospital Kauno klinikos
Kaunas, LT-50161
Lithuania
Vaidotas Urbanavicius Sole Proprietor Enterprise
Vilnius, LT-09112
Lithuania
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, 85-605
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
Gliwice, 44-101
Poland
Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medical Sciences
Poznan, 60-355
Poland
Uniwersytecki Szpital Kliniczny we Wroclawiu
Wroclaw, 52-007
Poland
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, 011863
Romania
Delta Health Care
Bucharest, 014142
Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, 400347
Romania
University Clinical Center of Serbia
Belgrade, 11000
Serbia
University Clinical Center of Serbia
Belgrade, 11000
Serbia
Narodni endokrinologicky a diabetologicky ustav
Ľubochňa, 03491
Slovakia
Hosiptal Universitario de la Ribera
Alzira, 46600
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, 08916
Spain
Hospital Ramón y Cajal
Madrid, 28034
Spain
Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, 15705
Spain
Hospital Universitario Virgen del Rocio
Seville, 41013
Spain
Karolinska University Hospital
Stockholm, 17176
Sweden
Uppsala University Hospital
Uppsala, 751 85
Sweden
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW
United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
United Kingdom