Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia

Phase 2 Completed 19 enrolled Tracey McLaughlin Eiger BioPharmaceuticals · collab

Non-randomizedSequentialDouble-blindTreatment

Summary

This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare disease with unmet clinical need.

Timeline

Start: 2016-05
Primary completion: 2017-06
Completion: 2017-06

Publications

Results Tan M, Lamendola C, Luong R, McLaughlin T, Craig C. Safety, efficacy and pharmacokinetics of repeat subcutaneous dosing of avexitide (exendin 9-39) for treatment of post-bariatric hypoglycaemia. Diabetes Obes Metab. 2020 Aug;22(8):1406-1416. doi: 10.1111/dom.14048. Epub 2020 May 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avexitide	Peptide	0.05 mg/kg	Subcutaneous
Subject	Avexitide	Peptide	0.15 mg/kg	Subcutaneous
Subject	Avexitide	Peptide	0.35 mg/kg	Subcutaneous
Subject	Avexitide	Peptide	0.38 mg/kg	Subcutaneous
Subject	Avexitide	Peptide	0.46 mg/kg	Subcutaneous

Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia

Summary

Timeline

Publications

Drugs

Indications