WithdrawnPhase 2

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

Lead sponsor

Zealand Pharma

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Prediabetes / glucose intolerance

Eligibility highlights

•BMI ≤40

Primary endpoint

•Nadir plasma glucose concentration

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04824872

Org study IDZP4207-20123

Timeline

Milestones

Study first posted2021-04-01actual

Last update posted2023-02-21actual

Study start2023-02estimated (month precision)

Primary completion2023-02estimated (month precision)

Study completion2023-02estimated (month precision)

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Nadir plasma glucose concentration