A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs (NCT06930625)
A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cedars Sinai Medical Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (73 Sites)
Showing the first 25 of 73 sites.
- Cedars Sinai Medical Center — Los Angeles, California
- Northwestern University — Chicago, Illinois
- Harvard Medical School — Boston, Massachusetts
- Washington University-School of Medicine — St Louis, Missouri
- Palm Research Center Inc — Las Vegas, Nevada
- NYU Grossman School of Medicine — New York, New York
- The Cleveland Clinic — Cleveland, Ohio
- The Ohio State University — Columbus, Ohio
- Oregon Health & Science University — Portland, Oregon
- Thomas Jefferson University — Philadelphia, Pennsylvania
- Medical University Graz — Graz,
- Medizinische Universitaet Wien - Division of Endocrinology and Metabolism — Vienna,
- UZ Gent — Ghent,
- CETI - Centro de Estudos em Terapias Inovadoras — Curitiba,
- Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM) — Fortaleza,
- Hospital das Clinicas da UFMG — Minas Gerais,
- Instituto Estadual do Cérebro Paulo Niemeyer (IECPN) — Rio de Janeiro,
- Hospital das Clinicas - University of Sao Paulo Medical School — São Paulo,
- University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD — Sofia,
- Rigshospitalet, Blegdamsvej 9 — Copenhagen,
- Zealand University Hospital — Køge,
- East Tallinn Central Hospital — Tallinn,
- North Estonia Medical Centre Foundation — Tallinn,
- CHU d'Angers — Angers,
- Hospices Civils de Lyon — Bron,
📞 Contact the Study Coordinator
Phone: +41 21 321 01 11
Email: clinicaltrials@debiopharm.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acromegaly
- A Study to Evaluate MAR002 for Acromegaly — Phoenix, Arizona
- Study of MAR002 in Healthy Men — Tempe, Arizona
Explore by condition: All Acromegaly clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.