Post Bariatric Hypoglycemia (PBH)
Post bariatric hypoglycemia is an increasingly recognized chronic side effect of bariatric surgeries that are commonly performed as a treatment for obesity and related comorbidities. Postoperative prevalence of hypoglycemia symptoms in bariatric surgery patients is thought to be as high as 38.5%. PBH is associated with uncontrolled spikes in postprandial insulin secretion leading to dangerous hypoglycemic events. Neuroglycopenic symptoms can include behavioral changes, shakiness, fatigue, dizziness, seizure, confusion, sweating, coma and potential death. These symptoms can be debilitating with a significant negative impact on quality of life, can dangerously impair normal day-to-day activities and can be life-threatening.
In patients diagnosed with PBH, Mizagliflozin has been shown to significantly reduced secretion of Insulin and GIP while improving both postprandial peak glucose and glucose nadir.
Clinical Study VGX-001-011
This phase 2 clinical study (NCT05541939) was a randomized, sequential crossover single dose study to determine the effect of Mizagliflozin on safety, tolerability and postprandial glucose and insulin in patients with PBH after a mixed meal tolerance test (MMTT).
Clinical Study VGX-001-012
This multicenter, randomized, single-blind, placebo-controlled, dose-ranging and regimen-finding study enrolled 15 patients actively struggling with symptoms of PBH. Each patient was dosed with two doses of mizagliflozin and placebo, each for seven days (21-day study period) with a one-week washout period between regimens. Mixed meal tolerance tests were administered at the conclusion of each treatment period, and all patients wore blinded continuous glucose monitors throughout each treatment period. We expect topline data from this study to be available summer of 2024.
Patients and investigators interested to learn more about upcoming studies should contact the Vogenx clinical team here.