A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN — 36 Weeks
Trial sites (74)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | 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 |
| Hospital Medical Center L2 | Brasília | Brazil | Not Yet 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 |
+ 34 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
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