Last updated 12 days ago
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
119 patients around the world
Available in Spain, United States, Belgium, Brazil
Debiopharm International SA
1Research sites
119Patients around the world
This study is for people with
Endocrine disorders
Acromegaly
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Patients ≥18 years of age.Patients who are 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 ≤1x ULN.Acromegaly diagnosis, defined as per protocol.Adequate bone marrow, hepatic and renal function.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.Other protocol-defined criteria apply.
- Compression of optic chiasm causing visual defects.Symptomatic cholelithiasis or bile duct dilatation.Planned cholecystectomy during the trial duration.Acute or chronic pancreatitis.Pituitary radiotherapy.Uncontrolled hypothyroidism.Uncontrolled diabetes.Pituitary surgery within 6 months before screening or planned on trial.Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening.Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism.Other protocol-defined criteria apply.
Sites
Núcleo de Pesquisa e Desenvolvimento de Medicamentos da UFC - NPDM
Recruiting
StudyOXTEND™-03
SponsorDebiopharm International SA
Study typeInterventional
Conditions
Acromegaly
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06930625
