NCT05541939

Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects

Phase 2 Randomized Single Ascending Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin Formulations on Postprandial Glucose and Insulin Levels

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Vogenx, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).

Detailed description

This is a Phase 2 randomized, sequential crossover single ascending dose study in PBH subjects to determine the effect of two mizagliflozin formulations This study will examine single doses of mizagliflozin in either a liquid or encapsulated formulation. Subjects will be randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (MMTT).

Conditions

• Postbariatric Hypoglycemia

Interventions

Type	Name	Description
DRUG	Mizagliflozin	Encapsulated or Liquid Formulation

Timeline

• Start date: 2022-09-13
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2022-09-15
• Last updated: 2024-06-25
• Results posted: 2024-06-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study