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

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand Pharma

Criteria

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