NCT05721729

Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions

Phase 2 Crossover, Randomized, Placebo-Controlled, Single-Blind, Repeat Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin on Adverse Events and Postprandial Glucose Excursions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Vogenx, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions.

Detailed description

This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions. This study will examine repeat doses of mizagliflozin and placebo while also evaluating dosing regimen. Up to 15 subjects are expected to complete the study. Subjects will be randomly assigned to a treatment arm within a cohort. Each subject should receive placebo and 2 active dose regimens in a crossover fashion.

Conditions

• Postbariatric Hypoglycemia

Interventions

Type	Name	Description
DRUG	Mizagliflozin	Encapsulated
DRUG	Placebo	Encapsulated

Timeline

• Start date: 2023-06-23
• Primary completion: 2024-05-01
• Completion: 2025-06-01
• First posted: 2023-02-10
• Last updated: 2025-12-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study