DRUG
Debio 4126
IM injection, a 12-week extended-release formulation of octreotide
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Status
Recruiting
Phase
Phase 3
Enrollment
119
Locations
72
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
IM injection of mannitol suspension
Timeline
From registration to results.
First posted
Apr 16, 2025
Study start
Nov 26, 2025
Primary completion
Jun 2028
Study completion
Mar 2029
Results posted
Not reported
Registry updated
Jul 24, 2026
Outcomes
What the study measures.
Primary outcomes
Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN
Time frame · 36 Weeks
Secondary outcomes
Arm C: Percentage of Participants With IGF-1 ≤1x ULN
Time frame · 36 Weeks
Percent Change From Baseline in IGF-1 Values
Time frame · Up to 108 Weeks
Percentage of Participants With IGF-1 ≤1x ULN
Time frame · Up to 108 Weeks
Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL
Time frame · Up to 108 Weeks
Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame · Up to 36 Weeks
Percentage of Participants Who Experienced at Least One TEAE
Time frame · Up to 113 Weeks
Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment
Time frame · Up to 108 Weeks
Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score
Time frame · Up to 108 Weeks
Double-blind Period: Percentage of Participants Taking Rescue Medication
Time frame · Up to 36 Weeks
Trough Plasma Concentration (Ctrough) of Debio 4126
Time frame · Up to 96 Weeks
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion criteria 1. Patients ≥18 years of age 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 1. Compression of optic chiasm causing visual defects 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
Study locations
72 registered sites.
Austria · Belgium · Brazil · Bulgaria · Denmark · Estonia · France · Germany · Hungary · Israel · Italy · Latvia · Lithuania · Poland · Romania · Serbia · Slovakia · Spain · Sweden · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
NYU Grossman School of Medicine
New York, New York, 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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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