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Clinical Trials in the UK / NCT06930625
Recruiting Phase 3

A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

NCT06930625 · tracked via the Priya Life Science UK tracker
Sponsor
Debiopharm International SA
Phase
Phase 3
Started
2025-11-26
Last updated
2026-08-24

Condition(s) studied

Acromegaly

Investigational drug(s) / intervention(s)

Debio 4126Placebo

Debio 4126: IM injection, a 12-week extended-release formulation of octreotide

Placebo: IM injection of mannitol suspension

Study 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

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
Cedars Sinai Medical Center Los Angeles California Recruiting
Northwestern University Chicago Illinois Recruiting
Harvard Medical School Boston Massachusetts Recruiting
Washington University-School of Medicine St Louis Missouri Recruiting
Palm Research Center Inc Las Vegas Nevada Recruiting
NYU Grossman School of Medicine New York New York Not Yet Recruiting
The Cleveland Clinic Cleveland Ohio Recruiting
The Ohio State University Columbus Ohio Recruiting
Oregon Health & Science University Portland Oregon Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Medical University Graz Graz Austria Recruiting
Medizinische Universitaet Wien - Division of Endocrinology and Metabolism Vienna Austria Recruiting
UZ Gent Ghent Belgium Recruiting
CETI - Centro de Estudos em Terapias Inovadoras Curitiba Brazil Recruiting
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM) Fortaleza Brazil Recruiting
Hospital das Clinicas da UFMG Minas Gerais Brazil Recruiting
Instituto Estadual do Cérebro Paulo Niemeyer (IECPN) Rio de Janeiro Brazil Recruiting
Hospital das Clinicas - University of Sao Paulo Medical School São Paulo Brazil Recruiting
University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD Sofia Bulgaria Recruiting
Rigshospitalet, Blegdamsvej 9 Copenhagen Denmark Recruiting
Zealand University Hospital Køge Denmark Recruiting
East Tallinn Central Hospital Tallinn Estonia Recruiting
North Estonia Medical Centre Foundation Tallinn Estonia Recruiting
CHU d'Angers Angers France Recruiting
Hospices Civils de Lyon Bron France Recruiting
APHP - Hôpital Bicêtre Le Kremlin-Bicêtre France Recruiting
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception Marseille France Recruiting
Hopital Haut-Leveque Pessac France Recruiting
CHU Toulouse - Hôpital Larrey Toulouse France Recruiting
Charité Universitätsmedizin Berlin Berlin Germany Recruiting
Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi Munich Germany Recruiting
Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog Würzburg Germany Recruiting
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika Budapest Hungary Recruiting
Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia Budapest Hungary Recruiting
University of Szeged Faculty of Medicine Szeged Hungary Recruiting
Bnai Zion Medical Center Haifa Israel Recruiting
Rambam Health Care Campus Haifa Israel Recruiting
Rabin Medical Center - Beilinson Campus Petah Tikva Israel Recruiting
Tel Aviv Sourasky Medical Center Tel Aviv Israel Recruiting
Azienda ospedaliero Universitaria di Ferrara Ferrara Italy Recruiting

+ 33 more sites — see the full list on the official registry below.

More Debiopharm International SA trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06930625 on ClinicalTrials.gov ↗ ← All trials in the UK