A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Acromegaly
In brief
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.
Key facts
- Study ID
- NCT06930625
- Run by
- Debiopharm International SA
- People needed
- 119
- Starts
- 2025-11-26
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Washington University-School of Medicine — St Louis, Missouri, United States (enrolling)
- Palm Research Center Inc — Las Vegas, Nevada, United States (enrolling)
- Harvard Medical School — Boston, Massachusetts, United States (enrolling)
- The Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- The Ohio State University — Columbus, Ohio, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
- Medical University Graz — Graz, Austria (enrolling)
- Medizinische Universitaet Wien - Division of Endocrinology and Metabolism — Vienna, Austria (enrolling)
- UZ Gent — Ghent, Belgium (enrolling)
- CETI - Centro de Estudos em Terapias Inovadoras — Curitiba, Brazil (enrolling)
- Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM) — Fortaleza, Brazil (enrolling)
- Hospital das Clinicas da UFMG — Minas Gerais, Brazil (enrolling)
- Instituto Estadual do Cérebro Paulo Niemeyer (IECPN) — Rio de Janeiro, Brazil (enrolling)
- Hospital das Clinicas - University of Sao Paulo Medical School — São Paulo, Brazil (enrolling)
- University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD — Sofia, Bulgaria (enrolling)
- Rigshospitalet, Blegdamsvej 9 — Copenhagen, Denmark (enrolling)
- Zealand University Hospital — Køge, Denmark (enrolling)
- East Tallinn Central Hospital — Tallinn, Estonia (enrolling)
- North Estonia Medical Centre Foundation — Tallinn, Estonia (enrolling)
- CHU d'Angers — Angers, France (enrolling)
- Hospices Civils de Lyon — Bron, France (enrolling)
- APHP - Hôpital Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
Full record on ClinicalTrials.gov
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