Mizagliflozin for Low Blood Sugar
Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Vogenx, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
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.Inclusion Criteria
You had a specific type of stomach surgery more than 6 months ago.
You have been diagnosed with PBH.
Exclusion Criteria
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
You are currently taking insulin or certain medications that stimulate insulin production.
You have a medical condition that may cause low blood sugar, like insulinoma or adrenal insufficiency.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive placebo and two doses of encapsulated mizagliflozin in a crossover fashion
6 weeks
Multiple visits for dosing and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 week
Treatment Details
Interventions
- Mizagliflozin
- Placebo
Trial Overview 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.
Participant Groups
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.
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Who Is Running the Clinical Trial?
Vogenx, Inc.
Lead Sponsor
Trials
2
Recruited
20+
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