Actively Recruiting
A Phase 3 Randomized Double-Blind and Open-Label Trial to Assess the Efficacy and Safety of Debio 4126, a 12-Week Octreotide Formulation, in Adults With Acromegaly Previously Treated With Somatostatin Analogs
Led by Debiopharm International SA · Updated on 2026-05-28
119
Participants Needed
71
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Debio 4126, a 12-week extended-release formulation of octreotide, in adults with acromegaly who have previously been treated with somatostatin analogs. The study aims to assess how well Debio 4126 maintains insulin-like growth factor 1 (IGF-1) levels at or below the upper limit of normal compared to a placebo during a double-blind period lasting 36 weeks. Participants will be randomly assigned to receive either Debio 4126 or a placebo by intramuscular injection once every 12 weeks for a total of three injections during the double-blind period. Those who meet specific IGF-1 criteria at week 34 may continue into an open-label period receiving Debio 4126 injections every 12 weeks for an additional 24 to 60 weeks. Rescue medication is available for participants whose acromegaly is not well controlled during the study. Throughout the study, participants will undergo regular assessments of IGF-1 and growth hormone levels, safety monitoring, and evaluations of local tolerability at the injection site. The main outcome is the percentage of participants maintaining IGF-1 levels at or below the upper limit of normal after 36 weeks. The study may last up to approximately 108 weeks for some participants, including follow-up and treatment periods.
CONDITIONS
Brief 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
- Currently receiving octreotide or lanreotide alone for acromegaly for at least 6 months, with a stable dose for the last 12 weeks
- Insulin-like growth factor 1 (IGF-1) at or below the upper limit of normal at screening
- Diagnosis of acromegaly as defined by the study protocol
- Adequate bone marrow, liver, and kidney function
- For Period 2 entry: IGF-1 at or below the upper limit of normal at Week 34 or up to Week 48 if treated with rescue medication
- Other criteria defined by the study protocol
You will not qualify if you...
- Visual defects caused by compression of the optic chiasm
- Symptomatic gallstones or bile duct enlargement
- Planned gallbladder removal during the study
- 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 before screening, pegvisomant or dopamine agonists within 3 months before screening
- Recent or ongoing heart or blood vessel problems including heart failure, heart attack, stroke, certain irregular heartbeats, or pulmonary embolism
- Other criteria defined by the study protocol
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 weeks
Participants receive intramuscular injections of Debio 4126 or placebo every 12 weeks during the initial 36-week double-blind period. Rescue medication may be given if acromegaly is not well controlled.
3 injections given every 12 weeks
Duration - 24 to 60 weeks
Eligible participants with controlled IGF-1 begin an open-label treatment period receiving Debio 4126 injections every 12 weeks for an additional 24 to 60 weeks, with rescue medication available until Week 48 if needed.
2 to 5 injections given every 12 weeks
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
Actively 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
Actively 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
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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