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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postbariatric Hypoglycemia
• Intervention / Treatment: Drug: Mizagliflozin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado / Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined.	Drug: Mizagliflozin; Encapsulated; Drug: Placebo; Encapsulated
Experimental: Cohort 2; 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; Encapsulated; Drug: Placebo; Encapsulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMTT peak glucose concentration after dosing	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
MMTT peak insulin concentration after dosing	Time course of insulin concentrations during MMTT	0-3 hours following liquid meal
MMTT time to peak glucose concentration after dosing	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
MMTT time to peak insulin concentration after dosing	Time course of insulin concentrations during MMTT	0-3 hours following liquid meal
MMTT glucose concentration	MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing	0-3 hours following liquid meal
MMTT insulin concentration	MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing	0-3 hours following liquid meal

Collaborators and Investigators

• Sponsor: Vogenx, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: VGX-001-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No