Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Camurus AB
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 long-acting repeatable (LAR) or lanreotide autogel (ATG) for at least 3 months as monotherapy prior to screening
Insulin-like growth factor-1 (IGF-1) levels ≤1x upper limit of normal (ULN) at screening
Adequate liver, pancreatic, renal and bone marrow functions
Normal ECG
You may not be if
Growth hormone (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%)
