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

Phase 2

Completed

• Conditions: Postbariatric Hypoglycemia
• Interventions: Drug: Mizagliflozin

• Registration Number: NCT05541939
• Lead Sponsor: Vogenx, Inc.

Brief 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).

Study Timeline

• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-12
• Study Start: 2022-09-13
• Study First Posted: 2022-09-15
• Primary Completion: 2023-02-17
• Study Completion: 2023-02-17
• Status Verified: 2024-05
• Results First Submitted: 2024-05-02
• Results First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Results First Posted: 2024-06-25
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
• Diagnosis of PBH

Exclusion Criteria

• History of current medical conditions (other than PBH) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia.
• Current use of insulin or insulin secretagogues.
• History of current dumping syndrome.
• History of current fasting hypoglycemia.
• Pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Arm A	Mizagliflozin	Subjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin
Treatment Arm B	Mizagliflozin	Subjects will receive one dose of liquid formulation (Period 1), and one dose (optional) of encapsulated mizagliflozin (Period 2)

Primary Outcome Measures

Name	Time	Method
Glucose Nadir After Mizagliflozin Dosing	0-3 hours following liquid meal	Time course of glucose concentrations during MMTT

Trial Locations

Locations (2)

Stanford; 🇺🇸 Palo Alto, California, United States

University of Colorado / Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States