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.
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
Compression of optic chiasm causing visual defects
Symptomatic cholelithiasis or bile duct dilatation
Planned cholecystectomy during the trial duration
Acute or chronic pancreatitis