Recent Updates
Recently added Catalysts

Glucagon RTU

Phase 2

Hyperinsulinemic Hypoglycemia | Small molecule | Metabolic |Xeris Biopharma Holdings, Inc.|Last Updated: May 21, 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Glucagon RTU · 1 trial · 1 indication

Phase 2 1
NCT03770637Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric SurgeryHyperinsulinemic Hypoglycemia
COMPLETED14 Analytics
PHASE2COMPLETED
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Hyperinsulinemic HypoglycemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Blood glucose recovery: CRC
At 15 minutes following administration of study drug

Number of subjects with blood glucose \> 70 mg/dL

Blood glucose recovery: Out-patient
At 15 minutes following administration of study drug

Frequency of blood glucose \> 70 mg/dL

Secondary Endpoints

Symptomatic Recovery: CRC
At 15, 30, and 60 minutes following administration of study drug
Incidence of severe hypoglycemia: CRC
At 0-240 minutes following administration of study drug
Incidence of severe hypoglycemia: Out-patient
During 12 weeks of out-patient treatment
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Glucagon RTU (glucagon injection)EXPERIMENTALGlucagon Ready-to-Use (RTU); 60 μL injection (0.3 mg glucagon)
PlaceboPLACEBO_COMPARATORNon-active vehicle for Glucagon RTU; 60 μL injection

Interventions

NameTypeDescription
Glucagon RTUDRUGGlucagon RTU is a sterile subcutaneous injectable non-aqueous solution formulation supplied in a vial and administered via syringe.
PlaceboOTHERThe placebo is a non-active version of Glucagon RTU formulation, containing the same solvent and excipients (i.e., vehicle).
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Male or female 2. Aged 18 to 75 years of age, inclusive 3. Symptoms of hypoglycemia that developed after bariatric surgery (Roux-en-Y gastric bypass \[RYGB\] only) in the absence of antidiabetic medications 4. History of bariatric surgery (RYGB only), at least 6 months prior ...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Glucagon RTU

What is Glucagon RTU used for?

Glucagon RTU is an investigational ready-to-use glucagon formulation being studied for hyperinsulinemic hypoglycemia and hypoglycemia. It is being evaluated for use in patients with hyperinsulinemic hypoglycemia after bariatric surgery and for prevention of exercise-induced hypoglycemia in adults with type 1 diabetes.

Who makes Glucagon RTU?

Glucagon RTU is being developed by Xeris Biopharma Holdings, Inc., a company traded on the stock exchange under the ticker XERS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in metabolic conditions.

What phase is Glucagon RTU in?

Glucagon RTU is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating hypoglycemia-related conditions.

What clinical trials is Glucagon RTU in?

Glucagon RTU has been studied in two completed Phase 2 trials. NCT03770637 evaluated the drug in patients with hyperinsulinemic hypoglycemia after bariatric surgery in the United States. NCT03841526 assessed its use for preventing exercise-induced hypoglycemia in adults with type 1 diabetes in Canada.

Is Glucagon RTU the same as regular glucagon?

Glucagon RTU is a ready-to-use formulation of glucagon, a hormone that raises blood sugar. Unlike traditional glucagon emergency kits that require mixing before injection, this formulation is designed to be used directly without reconstitution, potentially offering greater convenience for managing hypoglycemia.