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

• Sponsor: Vogenx, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05721729
• Collaborator: (none)
• Enrollment: 15
• Arms: 2
• Anticipated Duration (Months): 6

Study Details

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	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
• Anticipated 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
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

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
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

Outcome Measures

Primary Outcome Measures

1. Adverse Events [Through study completion, 43 days]

   Number of participants with adverse events

2. Vital Signs [Through study completion, 43 days]

   Number of participants with abnormal vital signs

3. Laboratory Tests [Through study completion, 43 days]

   Number of participants with abnormal laboratory tests

4. Glucose nadir after dosing [0-3 hours following liquid meal]

   Time course of glucose concentrations during MMTT

Secondary Outcome Measures

1. MMTT peak glucose concentration after dosing [0-3 hours following liquid meal]

   Time course of glucose concentrations during MMTT

2. MMTT peak insulin concentration after dosing [0-3 hours following liquid meal]

   Time course of insulin concentrations during MMTT

3. MMTT time to peak glucose concentration after dosing [0-3 hours following liquid meal]

   Time course of glucose concentrations during MMTT

4. MMTT time to peak insulin concentration after dosing [0-3 hours following liquid meal]

   Time course of insulin concentrations during MMTT

5. MMTT glucose concentration [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 [0-3 hours following liquid meal]

   MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

No locations specified.

Sponsors and Collaborators

• Vogenx, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vogenx, Inc.
• ClinicalTrials.gov Identifier: NCT05721729
• Other Study ID Numbers: VGX-001-012
• First Posted: Feb 10, 2023
• Last Update Posted: Feb 10, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypoglycemia

Study Results

No Results Posted as of Feb 10, 2023