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

NCT05721729 | Completed Phase 2 FDA Drug

• 1 other identifier: VGX-001-012
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postbariatric Hypoglycemia

Outcome Measures

Primary Outcomes (4)

• Adverse Events

  Number of participants with adverse events

  Through study completion, 43 days

• Vital Signs

  Number of participants with abnormal vital signs

  Through study completion, 43 days

• Laboratory Tests

  Number of participants with abnormal laboratory tests

  Through study completion, 43 days

• Glucose nadir after dosing

  Time course of glucose concentrations during MMTT

  0-3 hours following liquid meal

Secondary Outcomes (6)

• MMTT peak glucose concentration after dosing

  0-3 hours following liquid meal

• MMTT peak insulin concentration after dosing

  0-3 hours following liquid meal

• MMTT time to peak glucose concentration after dosing

  0-3 hours following liquid meal

• MMTT time to peak insulin concentration after dosing

  0-3 hours following liquid meal

• MMTT glucose concentration

  0-3 hours following liquid meal

Study Arms (2)

Cohort 1

EXPERIMENTAL

Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined.

Drug: Mizagliflozin; Drug: Placebo

Cohort 2

EXPERIMENTAL

Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined.

Drug: Mizagliflozin; Drug: Placebo

Interventions

Mizagliflozin DRUG

Encapsulated

Cohort 1; Cohort 2

Placebo DRUG

Encapsulated

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Vogenx, Inc.: lead

Study Sites (2)

Stanford

Palo Alto, California, 94304, United States

Location

University of Colorado / Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

mizagliflozin

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 10, 2023
• Study Start: June 23, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (2)