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

• ClinicalTrials.gov Identifier: NCT05721729
• Recruitment Status: Active, not recruiting
• First Posted: February 10, 2023
• Last Update Posted: March 20, 2024
• Sponsor: Vogenx, Inc.
• Information provided by (Responsible Party): Vogenx, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postbariatric Hypoglycemia	Drug: Mizagliflozin; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: June 23, 2023
• Estimated Primary Completion Date: May 2024
• Estimated Study Completion Date: August 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Adverse Events [ Time Frame: Through study completion, 43 days ]
   Number of participants with adverse events
2. Vital Signs [ Time Frame: Through study completion, 43 days ]
   Number of participants with abnormal vital signs
3. Laboratory Tests [ Time Frame: Through study completion, 43 days ]
   Number of participants with abnormal laboratory tests
4. Glucose nadir after dosing [ Time Frame: 0-3 hours following liquid meal ]
   Time course of glucose concentrations during MMTT

Secondary Outcome Measures :

1. MMTT peak glucose concentration after dosing [ Time Frame: 0-3 hours following liquid meal ]
   Time course of glucose concentrations during MMTT
2. MMTT peak insulin concentration after dosing [ Time Frame: 0-3 hours following liquid meal ]
   Time course of insulin concentrations during MMTT
3. MMTT time to peak glucose concentration after dosing [ Time Frame: 0-3 hours following liquid meal ]
   Time course of glucose concentrations during MMTT
4. MMTT time to peak insulin concentration after dosing [ Time Frame: 0-3 hours following liquid meal ]
   Time course of insulin concentrations during MMTT
5. MMTT glucose concentration [ Time Frame: 0-3 hours following liquid meal ]
   MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
6. MMTT insulin concentration [ Time Frame: 0-3 hours following liquid meal ]
   MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford

Palo Alto, California, United States, 94304

United States, Colorado

University of Colorado / Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Sponsors and Collaborators

Vogenx, Inc.

More Information

• Responsible Party: Vogenx, Inc.
• ClinicalTrials.gov Identifier: NCT05721729
• Other Study ID Numbers: VGX-001-012
• First Posted: February 10, 2023
• Last Update Posted: March 20, 2024
• Last Verified: March 2024

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypoglycemia; Glucose Metabolism Disorders; Metabolic Diseases