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

Zealand Pharma

Status and phase: Withdrawn; Phase 2

Conditions: Hypoglycemia; Glucose Metabolism Disorders

Treatments: Drug: Placebo; Drug: Dasiglucagon

Study type: Interventional

Funder types: Industry

Identifiers

NCT04824872

ZP4207-20123

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose

Treatment:

Drug: Placebo

Drug: Dasiglucagon

Drug: Dasiglucagon

Sequence 2

Experimental group

Description:

Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo

Treatment:

Drug: Placebo

Drug: Dasiglucagon

Drug: Dasiglucagon

Sequence 3

Experimental group

Description:

Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose

Treatment:

Drug: Placebo

Drug: Dasiglucagon

Drug: Dasiglucagon

Sequence 4

Experimental group

Description:

Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo

Treatment:

Drug: Placebo

Drug: Dasiglucagon

Drug: Dasiglucagon

Sequence 5

Experimental group

Description:

Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose

Treatment:

Drug: Placebo

Drug: Dasiglucagon

Drug: Dasiglucagon

Sequence 6

Experimental group

Description:

Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose

Treatment:

Drug: Placebo

Drug: Dasiglucagon

Drug: Dasiglucagon