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G-Pump

Phase 2

Hypoglycemia | Small molecule | Metabolic |Xeris Biopharma Holdings, Inc.|Trials Updated: Oct 30, 2018

G-Pump target and mechanism

ModalitySmall molecule

Also known as G-Pump™ (glucagon infusion)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

G-Pump clinical trials

G-Pump · 1 trial · 2 indications

Phase 2 1
NCT02733588Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery PatientsHypoglycemia
COMPLETED8 Analytics
PHASE2COMPLETED
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
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Study Endpoints

Primary Endpoints

Detection/Notification of Hypoglycemia
0 - 120 minutes following dosing

Frequency with which the device controller software correctly identifies impending hypoglycemia (glucose \< 75 mg/dl) and notifies the investigator to initiate treatment. Reported as the number of successful identifications.

Secondary Endpoints

Number of Subjects With Severe Hypoglycemia
0 - 120 minutes following dosing
Number of Subjects With Rebound Hyperglycemia
0 - 120 minutes following dosing
Glucose Time in Range
0 - 120 minutes following dosing
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
G-Pump™ (glucagon infusion)EXPERIMENTAL0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump

Interventions

NameTypeDescription
G-Pump™ (glucagon infusion)DRUG0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose. * willingness to provide inform...

Countries:United States
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Frequently asked questions about G-Pump

What is G-Pump?

G-Pump is an investigational glucagon infusion therapy developed by Xeris Biopharma Holdings, Inc. for hypoglycemia. It is delivered from an OmniPod pump and was studied in post-bariatric surgery patients to prevent low blood glucose. It is a small molecule product in Phase 2 development and is not approved for commercial use.

What is G-Pump used for?

G-Pump is being developed to prevent hypoglycemia, with its clinical study focused on post-bariatric surgery patients who experience low blood sugar. The Phase 2 trial enrolled adults aged 18 and older of any sex in the United States. It remains investigational and has not been approved for any indication.

Who makes G-Pump?

G-Pump is developed by Xeris Biopharma Holdings, Inc., which trades on the Nasdaq under the ticker XERS. The company is the sponsor behind the glucagon infusion program and its delivery from an OmniPod pump for hypoglycemia prevention in post-bariatric surgery patients.

What phase is G-Pump in?

G-Pump is in Phase 2 development. Its single recorded trial, NCT02733588, is a completed Phase 2 study. Because no approval has been granted, G-Pump remains an investigational therapy rather than an approved product, and further clinical development would be required before any regulatory submission.

What clinical trials is G-Pump in?

G-Pump has been studied in one completed Phase 2 trial, NCT02733588, titled Delivery of G-Pump (Glucagon Infusion) From an OmniPod to Prevent Hypoglycemia in Post-Bariatric Surgery Patients. The uncontrolled, non-randomized study enrolled 8 participants in the United States and has completed; no active trials are ongoing.

Is G-Pump the same as glucagon infusion?

Yes. G-Pump is also known as G-Pump (glucagon infusion), so searches for either name refer to the same Xeris Biopharma Holdings, Inc. product. It is a small molecule glucagon therapy delivered continuously from an OmniPod pump, studied in Phase 2 for preventing hypoglycemia in post-bariatric surgery patients.