Actively Recruiting
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Led by Debiopharm International SA · Updated on 2026-04-28
119
Participants Needed
71
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months at a stable dose for the last 12 weeks
- IGF-1 at screening at or below 1x upper limit of normal
- Diagnosed with acromegaly as defined by the study protocol
- Adequate bone marrow, liver, and kidney function
- For entry into Period 2: IGF-1 at or below 1x upper limit of normal at Week 34, or up to Week 48 if treated with rescue medication
- Other criteria defined by the protocol
You will not qualify if you...
- Compression of optic chiasm causing visual defects
- Symptomatic gallstones or bile duct dilation
- Planned gallbladder removal during the trial
- Acute or chronic pancreatitis
- Previous pituitary radiotherapy
- Uncontrolled hypothyroidism
- Uncontrolled diabetes
- Pituitary surgery within 6 months before screening or planned during the trial
- Treatment with pasireotide within 6 months prior to screening, or pegvisomant or dopamine agonists within 3 months prior
- Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, heart attack, stroke, certain arrhythmias, and pulmonary embolism
- Other criteria defined by the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 71 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Harvard Medical School
Boston, Massachusetts, United States, 01952
Actively Recruiting
4
Washington University-School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Palm Research Center Inc
Las Vegas, Nevada, United States, 89128
Actively Recruiting
6
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
7
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
8
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
9
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
10
Medical University Graz
Graz, Austria, A-8036
Actively Recruiting
11
Medizinische Universitaet Wien - Division of Endocrinology and Metabolism
Vienna, Austria, 1090
Actively Recruiting
12
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
13
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, Brazil, 80030-110
Actively Recruiting
14
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM)
Fortaleza, Brazil, 60430-275
Actively Recruiting
15
Hospital das Clinicas da UFMG
Minas Gerais, Brazil, 30130-100
Not Yet Recruiting
16
Instituto Estadual do Cérebro Paulo Niemeyer (IECPN)
Rio de Janeiro, Brazil, 20231-092
Actively Recruiting
17
Hospital das Clinicas - University of Sao Paulo Medical School
São Paulo, Brazil, 5403000
Actively Recruiting
18
University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD
Sofia, Bulgaria, 1431
Actively Recruiting
19
Rigshospitalet, Blegdamsvej 9
Copenhagen, Denmark, DK-2100
Actively Recruiting
20
Zealand University Hospital
Køge, Denmark, 4600
Actively Recruiting
21
East Tallinn Central Hospital
Tallinn, Estonia, 10138
Actively Recruiting
22
North Estonia Medical Centre Foundation
Tallinn, Estonia, 13419
Actively Recruiting
23
CHU d'Angers
Angers, France, 49933
Actively Recruiting
24
Hospices Civils de Lyon
Bron, France, 69677
Actively Recruiting
25
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
26
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille, France, 13005
Actively Recruiting
27
Hopital Haut-Leveque
Pessac, France, 33600
Actively Recruiting
28
CHU Toulouse - Hôpital Larrey
Toulouse, France, 31059
Actively Recruiting
29
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
30
Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi
Munich, Germany, 80336
Actively Recruiting
31
Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog
Würzburg, Germany, 97080
Actively Recruiting
32
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, Hungary, 1083
Actively Recruiting
33
Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia
Budapest, Hungary, 1134
Actively Recruiting
34
University of Szeged Faculty of Medicine
Szeged, Hungary, 6725
Actively Recruiting
35
Bnai Zion Medical Center
Haifa, Israel, 3104802
Actively Recruiting
36
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
37
Rabin Medical Center - Beilinson Campus
Petah Tikva, Israel, 49100
Actively Recruiting
38
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
39
Azienda ospedaliero Universitaria di Ferrara
Ferrara, Italy, 44124
Actively Recruiting
40
Ospedale Policlinico San Martino IRCCS
Genova, Italy, 16132
Actively Recruiting
41
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
42
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Milan, Italy, 20122
Actively Recruiting
43
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
44
AOU Federico II Napoli
Naples, Italy, 80131
Not Yet Recruiting
45
Azienda Ospedale Università di Padova
Padova, Italy, 35124
Actively Recruiting
46
Fondazione Policlinico Universitario A Gemelli
Roma, Italy, 00168
Actively Recruiting
47
University of Torino
Torino, Italy, 10126
Actively Recruiting
48
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV-1002
Actively Recruiting
49
Lithuanian Health Science University Hospital Kauno klinikos
Kaunas, Lithuania, LT-50161
Actively Recruiting
50
Vaidotas Urbanavicius Sole Proprietor Enterprise
Vilnius, Lithuania, LT-09112
Actively Recruiting
51
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, Poland, 85-605
Actively Recruiting
52
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
Gliwice, Poland, 44-101
Actively Recruiting
53
Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medical Sciences
Poznan, Poland, 60-355
Actively Recruiting
54
Uniwersytecki Szpital Kliniczny we Wroclawiu
Wroclaw, Poland, 52-007
Actively Recruiting
55
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, Romania, 011863
Actively Recruiting
56
Delta Health Care
Bucharest, Romania, 014142
Actively Recruiting
57
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, Romania, 400347
Actively Recruiting
58
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Actively Recruiting
59
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Not Yet Recruiting
60
Narodni endokrinologicky a diabetologicky ustav
Ľubochňa, Slovakia, 03491
Actively Recruiting
61
Hosiptal Universitario de la Ribera
Alzira, Spain, 46600
Actively Recruiting
62
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
63
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
64
Hospital Universitario Germans Trias i Pujol
Barcelona, Spain, 08916
Actively Recruiting
65
Hospital Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
66
Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Spain, 15705
Actively Recruiting
67
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
68
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
69
Uppsala University Hospital
Uppsala, Sweden, 751 85
Actively Recruiting
70
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
71
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
Research Team
D
Debiopharm International S.A
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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