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Glucagon RTU

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03770637Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric SurgeryPHASE2 COMPLETED 14 — — May 10, 2019Feb 26, 2020May 21, 20205 United States
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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
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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).
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Eligibility Criteria
Age Range18 Years — 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
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