Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery

Exclusion Criteria

• •1. Documented hypoglycemia occurring in the fasting state (\> 12 hours fast) within 12 months of study entry
• •2. Hypoglycemic unawareness as evidenced by a Gold Scale score \> 4 at screening
• •3. Early Dumping Syndrome
• •4. Known insulinoma or adrenal insufficiency
• •5. Active treatment with any insulin/insulin secretagogues, or other diabetes medications except for acarbose and glucagon-like peptide 1 (GLP-1) analogues
• •6. Chronic kidney disease Stage 4 or 5 or an estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2 at screening
• •7. Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 3 times the upper limit of normal (ULN); hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL
• •8. Congestive heart failure, New York Heart Association Class III or IV
• •9. History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening.
• •10. History of a cerebrovascular accident within 6 months prior to screening or with major neurological deficits
• •11. Seizure disorder (other than with suspected or documented hypoglycemia).
• •12. Active malignancy, except for basal or squamous cell skin cancers
• •13. Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease)
• •14. Major surgical operation within 30 days prior to screening
• •15. Hematocrit ≤ 30%
• •16. Bleeding disorder, treatment with warfarin, or platelet count \< 50,000 /mm3
• •17. Active alcohol abuse or substance abuse (per investigator assessment)
• •18. Current chronic administration of oral or parenteral corticosteroids, however topical, intraarticular, and inhaled corticosteroids are allowed
• •19. Use of an investigational drug within 15 days or 5 half-lives, whichever is longer, prior to screening
• •20. Member of a special vulnerable populations such as pregnant women, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable
• •21. Any other medical condition or finding that in the opinion of the investigator or sponsor, would compromise the safety of the subject or compromise the integrity of the study data