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

NCT ID: NCT05721729

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-23

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postbariatric Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1

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

Group Type EXPERIMENTAL

Mizagliflozin

Intervention Type DRUG

Encapsulated

Placebo

Intervention Type DRUG

Encapsulated

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.

Group Type EXPERIMENTAL

Mizagliflozin

Intervention Type DRUG

Encapsulated

Placebo

Intervention Type DRUG

Encapsulated

Interventions

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Mizagliflozin

Encapsulated

Intervention Type DRUG

Placebo

Encapsulated

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vogenx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford

Palo Alto, California, United States

Site Status

University of Colorado / Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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VGX-001-012

Identifier Type: -

Identifier Source: org_study_id