Exendin 9-39 has been studied in a Phase 1 study in patients with bariatric surgery induced hyperinsulinemic hypoglycemia. This double-blinded, randomized placebo-controlled study evaluated the efficacy of a single IV infusion of exendin 9-39 in subjects with hyperinsulinemic hypoglycemia after an oral glucose challenge.
Subjects for this study suffered from hypoglycemia due to high levels of insulin secretion resulting in plasma glucose levels 50 mg/dL or lower 1-2 hours after meals.
Eight patients were given an oral glucose challenge and randomized to a 3.5 hour exendin 9-39 infusion or placebo in cross-over design. Endpoints included hypoglycemia and associated symptoms.
Mean data of 8 patients from the Phase 1 infusion study is shown in the figure below. All eight patients treated with exendin 9-39 mirrored glucose levels of healthy patients, with none of their glucose levels falling below 50 mg/dL. In contrast, all eight placebo patients had a steep glucose fall, with glucose levels falling below 50 mg/dL, and patients had to be rescued with IV dextrose. In this single-dose study, exendin 9-39 was tolerated with no observed side-effects.
Results published in Diabetologia 2016.
See clinicaltrials.gov NCT02550145
Eiger Bio has recently completed a single-ascending dose, subcutaneous administration of Exendin 9-39 in 8 patients to explore the pharmacokinetic and pharmacodynamic profile of subcutaneously injected exendin 9-39. Data was presented at the American Diabetes Association in June.
Eiger Bio has recently completed a multiple-ascending dose, subcutaneous administration of Exendin 9-39 in 20 patients to export the pharmacokinetic profile of subcutaneously injected exendin 9-39. Data was presented at the American Diabetes Association in June 2017 (with link). See clinicaltrials.gov NCT02771574.
A Phase 2, Multicenter, Randomized, SinglE-Blind, Placebo-Controlled, Cross-oVer Study to Assess the Efficacy and Safety of ExeNdin 9-39 in PaTients with Postbariatric Hypoglycemia (PREVENT)