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

Phase 2CompletedNCT05541939

Vogenx, Inc.9 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postbariatric Hypoglycemia

Interventions

MizagliflozinDRUG

Encapsulated or Liquid Formulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (2)

Stanford

Palo Alto, California, United States

University of Colorado / Anschutz Medical Campus

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Glucose Nadir After Mizagliflozin Dosing

Time course of glucose concentrations during MMTT

Time frame: 0-3 hours following liquid meal

Data from ClinicalTrials.gov

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