A Trial to Assess the Long-term 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
• 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 and ≤2.0xULN at screening or IGF-1 levels ≤1xULN at screening with or without prior pituitary radiotherapy
• Adequate liver, pancreatic, renal and bone marrow functions
• Normal ECG

Exclusion criteria

For Roll-over Patients from NCT04076462:

• Unresolved, drug-related serious adverse event (SAE) from the preceding trial
• Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation

For New Patients:

• 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 within 3 years prior to screening
• Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)