A Study to Evaluate MAR002 for Acromegaly

Exclusion Criteria

• •1. History of hypersensitivity to monoclonal antibodies.
• •2. Participation in any other investigational drug study and received the last dose of investigational drug within 60 days or 5 half-lives (whichever is longer) of SV1.
• •3. History of severe allergic or anaphylactic reactions.
• •4. History of malignancy within 5 years prior to screening other than successfully treated basal or squamous cell carcinoma or localized cervical carcinoma. Any carcinoma in situ is allowed if appropriately treated within 2 years prior to screening. Subjects with a history of malignancy ≥ 5 years prior to screening should be considered cured of their oncological disease.
• •5. Pituitary surgery in the past 6 months prior to screening or any prior use of pituitary radiation therapy.
• •6. Pituitary adenoma with concern for mass effect on the optic chiasm or other critical structures within the study period as per judgment of the Investigator.
• •7. Poorly controlled diabetes mellitus, defined as having a hemoglobin A1c (HbA1c) ≥ 9.0%.
• •8. Severe renal insufficiency (estimated glomerular filtration rate \[eGFR by Chronic Kidney Disease Epidemiology Collaboration\] \< 30 mL/min/1.73 m2) or significant liver disease (including cirrhosis) prior to randomization.
• •9. History or evidence of any of the following within the previous 12 months: myocardial infarction, cardiac surgery revascularization (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty), hospitalization for heart failure, or stroke or transient ischemic attack.