A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Inclusion Criteria:

   - Male or female patients, ≥18 years at screening

   - Able to provide written informed consent to participate in the trial prior to any
   trial related procedures are performed

   - Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly

   - Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months
   as monotherapy prior to screening

   - IGF-1 levels ≤1xULN at screening

   - Adequate liver, pancreatic, renal and bone marrow functions

   - Normal ECG

Exclusion Criteria:

   - GH ≥2.5 μg/L at screening (cycle)

   - Have received medical treatment for acromegaly with pasireotide (within 6 months prior
   to screening), pegvisomant (within 3 months prior to screening), dopamine agonists
   (within 3 months prior to screening) or other investigational agents (within 30 days
   or 5 half-lives prior to screening [whichever is longer]

   - Patients who usually take octreotide LAR or lanreotide ATG less frequently than every
   4 weeks (e.g. every 6 weeks or 8 weeks)

   - Patients with compression of the optic chiasm causing any visual field defect for whom
   surgical intervention is indicated

   - Patients who have undergone major surgery/surgical therapy for any cause within 1
   month from screening

   - Patients who have undergone pituitary surgery within 6 months prior to screening

   - Patients who have received prior pituitary irradiation

   - Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)