Mizagliflozin for Low Blood Sugar

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Vogenx, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing mizagliflozin, a medication that helps manage blood sugar levels after eating. It targets people who have low blood sugar after bariatric surgery. The study will see if mizagliflozin reduces negative effects and stabilizes blood sugar.

Eligibility Criteria

This trial is for individuals who have had Roux-en-Y gastric bypass surgery over 6 months ago and are diagnosed with post-bariatric hypoglycemia (PBH). Participants must not be pregnant, using insulin or drugs that increase insulin release, and should not have other conditions causing low blood sugar.

Participant Groups

The study tests the effects of Mizagliflozin—a drug—on adverse events and how it affects blood sugar levels after eating in people with PBH. It's a phase 2 trial where participants will receive either Mizagliflozin or a placebo without knowing which one they're getting.

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment2 Interventions

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

Group II: Cohort 1Experimental Treatment2 Interventions

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