Status:
RECRUITING
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Lead Sponsor:
Debiopharm International SA
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 per...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
November 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT06930625
Start Date
November 26 2025
End Date
March 1 2029
Last Update
December 26 2025
Active Locations (67)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Harvard Medical School
Boston, Massachusetts, United States, 01952
4
Washington University-School of Medicine
St Louis, Missouri, United States, 63110