Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects

Inclusion Criteria:

• Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening
• Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates.
• Body mass index (BMI) ≤ 40 kg/m2
• Fasting plasma glucose between 72-106 mg/dL (4.0-6.0 mmol/l)

Exclusion Criteria:

• History of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients
• History of insulinoma, pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.
• Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 or end-stage renal disease at screening
• Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN)
• Active malignancy, except for basal or squamous cell skin cancers
• History of a cerebrovascular accident within 6 months prior to screening
• History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening.
• Congestive heart failure, New York Heart Association Class III or IV
• Concurrent administration of β-blocker therapy
• Clinically significant ECG abnormalities at screening