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

NCT04824872 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: ZP4207-20123
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Hypoglycemia; Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

• Nadir plasma glucose concentration

  From trial drug administration to 240 minutes after initiation of Mixed Meal Test

Secondary Outcomes (4)

• Percent time spent in hypoglycemia

  From trial drug administration to 240 minutes after initiation of Mixed Meal Test

• Percent time spent in clinical significant hypoglycemia

  From trial drug administration to 240 minutes after initiation of Mixed Meal Test

• Percent time spent in target range

  From trial drug administration to 240 minutes after initiation of Mixed Meal Test

• Percent time spent in hyperglycemia

  From trial drug administration to 240 minutes after initiation of Mixed Meal Test

Study Arms (6)

Sequence 1

EXPERIMENTAL

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

Drug: Dasiglucagon; Drug: Placebo

Sequence 2

EXPERIMENTAL

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

Drug: Dasiglucagon; Drug: Placebo

Sequence 3

EXPERIMENTAL

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

Drug: Dasiglucagon; Drug: Placebo

Sequence 4

EXPERIMENTAL

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

Drug: Dasiglucagon; Drug: Placebo

Sequence 5

EXPERIMENTAL

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

Drug: Dasiglucagon; Drug: Placebo

Sequence 6

EXPERIMENTAL

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

Drug: Dasiglucagon; Drug: Placebo

Interventions

Dasiglucagon DRUG

dasiglucagon SC, low dose

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Placebo DRUG

placebo for dasiglucagon

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand Pharma: lead

MeSH Terms

Conditions

Hypoglycemia; Glucose Metabolism Disorders

Interventions

dasiglucagon

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: February 1, 2023
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02